Atlas›Domain IX · Biomedical, neuro & digital›Guide 011
Guide IX-011

Addiction pharmacotherapy

A 28 · L 66 · M 620 interventions in the Trinity explorer
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[source: …] where a claim comes from[uncertain] not confirmed in a primary source[synthesis] the writer's reconstruction

1. Introduction

Version followed: United States: 42 CFR Part 8 as revised by the SAMHSA final rule "Medications for the Treatment of Opioid Use Disorder" (Federal Register, 2 February 2024; effective 2 April 2024, compliance 2 October 2024), together with the January 2023 removal of the buprenorphine DATA waiver ("X-waiver"), the MATE Act training requirement (from 27 June 2023) and SAMHSA TIP 63 Medications for Opioid Use Disorder (2020 update, which predates the waiver removal); confidentiality under 42 CFR Part 2 as amended by the 2024 final rule. United Kingdom: Drug misuse and dependence: UK guidelines on clinical management (the "Orange Book", 2017), NICE CG115 (alcohol-use disorders, 2011) as summarised by secondary sources and applied in an NHS service guideline (NHS Greater Glasgow and Clyde ADRS, 2020), and NICE NG209 (tobacco, 2021, updated 2025) as summarised in NICE quality standard QS207. Medicine warnings follow the US prescribing information: methadone (Dolophine label, revised 6/2021), buprenorphine–naloxone (Suboxone sublingual film label, revised 5/2025) and disulfiram; and FDA actions as reported (varenicline, 2016; over-the-counter naloxone nasal spray, 29 March 2023).

Sources include the methadone and buprenorphine–naloxone US labels, the FDA's March 2023 over-the-counter naloxone announcement (as republished), the HHS fact sheet on the 2024 42 CFR Part 2 final rule and a summary of the DEA's MATE Act letter. Still not verified from the primary page: the NICE CG115 recommendations page itself (two secondary summaries used instead), Orange Book chapter 4 onwards (pharmacological interventions, supervised consumption) and section 6.4 (naloxone), the DEA letter itself, and a naloxone or naltrexone label. These points stay marked [uncertain].

Addiction pharmacotherapy is not a psychotherapy. It is a group of prescribed medicines for opioid, alcohol and tobacco dependence, delivered by prescribers, opioid treatment programmes (OTPs), specialist drug and alcohol services, primary care and stop-smoking services. This guide is written for the psychotherapist working alongside them. The medicines act in different ways: methadone (which its label calls "a full opioid agonist") and buprenorphine ("a partial agonist at the mu-opioid receptor", per its label) replace and stabilise opioid effects; naltrexone blocks opioid effects and, in alcohol dependence, reduces drinking reward and craving; acamprosate reduces craving; disulfiram deters drinking through an unpleasant, potentially dangerous reaction to alcohol; nicotine replacement therapy (NRT) and varenicline reduce withdrawal and the reward of smoking. [source: methadone and Suboxone US prescribing information; TIP 63 executive summary; GG&C ADRS guideline; disulfiram prescribing information] [uncertain: naltrexone's antagonist action is from TIP 63 and the NHS guideline, not a label]

Core idea of how change happens: official sources treat dependence as a chronic, relapsing condition. Medication reduces the physiological drivers of use (withdrawal, craving, reward, overdose risk), which creates room for the psychosocial work of change. SAMHSA describes OUD as "a chronic, treatable illness" and says people taking OUD medication are in recovery; UK guidance says treatment means "a range of psychosocial treatment and support interventions, not just prescribing", and the NHS alcohol guideline reports better outcomes when medication is combined with ongoing psychosocial support. [source: TIP 63 executive summary; Orange Book 2017 §2.1; GG&C ADRS guideline]

The therapist does not prescribe, choose medicines, set or change regimens, or advise anyone to start, stop or change a medicine. The therapist's work is referral, collaboration with the prescriber or programme, psychoeducation, motivational work, reducing stigma, integrating psychosocial treatment, and planning for crisis and overdose risk. Every medication question goes to the prescriber. [synthesis, consistent with TIP 63 Part 4 as summarised]

2. Framework

There is no fixed session count. Medication for opioid dependence is often long-term; alcohol and tobacco medicines run for a course the prescriber decides. Below is the pathway as the therapist meets it, with the therapist's goals at each stage. Moving between stages is a shared clinical decision between the client and the prescriber or programme, not the therapist's call. [synthesis built on the sources below]

Stage A. Recognition and referral. Goal: notice opioid, alcohol or tobacco dependence, explain that medicines exist, and connect the client to a prescriber. Format: within ordinary therapy sessions. Move on when the client has an assessment appointment or has declined after an informed conversation. [synthesis]

Stage B. Assessment and treatment entry (prescriber-led). In US OTPs the 2024 rule removed the requirement for a one-year history of opioid addiction; admission now rests on clinical criteria such as active moderate-to-severe OUD, OUD in remission, or high risk of recurrence or overdose. Telehealth assessment is permitted for starting buprenorphine (audio-visual or audio-only) and for starting methadone by audio-visual telehealth, but not audio-only except in narrow circumstances. In the UK a named keyworker develops a care plan that is reviewed at set intervals. Therapist goal: support attendance, share relevant history with consent, manage anxiety about starting. [source: Federal Register 2024 final rule; Orange Book §2.2.4]

Stage C. Starting medication (prescriber-led). The prescriber handles the start. The therapist stays alert to the warning signs in section 4 (for example precipitated withdrawal, sedation, a disulfiram–alcohol reaction) and passes them on to the prescriber. Therapist sessions may be shorter or more supportive in this period. [synthesis]

Stage D. Stabilisation and integrated psychosocial treatment. Goal: psychosocial treatment alongside medication, such as motivational work, CBT or behavioural therapies, contingency management where the service offers it, family or couples work, linkage to mutual aid, and treatment of co-occurring depression, anxiety or trauma. US OTPs must offer counselling, medical, vocational and educational services onsite or by referral, but medication continuity is not contingent on counselling. [source: Federal Register 2024; Orange Book §3.1 and Table 1; GG&C ADRS guideline]

Stage E. Maintenance, review and recovery-building. Goal: relapse prevention, recovery capital, work, relationships, health. The NHS alcohol guideline sets prescriber review every 6 to 12 months or sooner if clinically indicated. Decisions to continue, change or end medication belong to the prescriber and client. [source: GG&C ADRS guideline; Federal Register 2024 on shared decision-making]

Stage F. Transitions and after treatment. Leaving treatment, finishing withdrawal, leaving prison or stopping naltrexone are high-risk points for overdose because tolerance falls. Goal: overdose-risk planning, naloxone awareness, rapid re-entry routes, continued therapy. [source: Orange Book §2.2.6; GG&C ADRS guideline on naltrexone]

3. Guiding principles

  • Dependence is a chronic, treatable condition. Expect long-term care and recurrences; treat a recurrence as clinical information, not failure. [source: TIP 63; GG&C ADRS]
  • Medication-supported recovery is recovery. Do not frame people on methadone or buprenorphine as "not really clean"; SAMHSA states patients on OUD medication are in recovery. [source: TIP 63]
  • Medication is not conditional on therapy. In US OTPs counselling is offered, not imposed as a condition of medication. Never use therapy attendance as leverage over someone's medication. [source: Federal Register 2024]
  • Combined care works better. Medication plus psychosocial support gives better outcomes for alcohol dependence, so integrate the two actively; NICE pairs alcohol medicines with an individual psychological intervention, and the Suboxone label places buprenorphine within a plan including counselling and psychosocial support. [source: GG&C ADRS citing NICE CG115; Drug and Alcohol Findings summary of CG115; Suboxone US prescribing information]
  • Shared decision-making and patient-centred plans. The 2024 rule emphasises practitioner–patient shared decision-making and individual plans of care; the Orange Book asks that patients be involved in their own goals. Support the client's voice in prescriber decisions. [source: Federal Register 2024; Orange Book §1.2.5.4]
  • Stay within scope. Never advise starting, stopping or changing a medicine, or comment on dose. Route every medication question to the prescriber. [synthesis]
  • Language matters. Use person-first, non-stigmatising language ("person with opioid use disorder", "medication", "recurrence"); TIP 63: "The words you use to describe OUD and an individual with OUD are powerful." [source: TIP 63; Federal Register 2024 on replacing stigmatising terms]
  • Avoid stigmatising environments. Staff attitudes, the setting and communication all affect stigma; check your own. [source: Orange Book §2.7.1]
  • Harm reduction sits alongside recovery. The 2024 rule expects OTPs to provide harm-reduction services, including infection education and testing and drug-checking strips where lawful. Accept goals short of abstinence. [source: Federal Register 2024; Orange Book §2.2.3 milestones]
  • Overdose risk is the main safety issue. Risk is highest soon after leaving treatment or prison and when tolerance has fallen; plan for it explicitly. [source: Orange Book §1.2.3, §2.2.6]
  • Coordinate care for co-occurring mental health problems. Coexisting mental health and substance problems need coordinated care planning; you are often the mental-health half of that plan. [source: Orange Book §7.9 as listed]
  • Involve families and carers with consent. They are a valuable resource and should get information on overdose, naloxone and safe storage of medicines. [source: Orange Book §1.2.5.5, §2.7.12]
  • Safeguard children. Assess risks to dependent children early, including storage of medicines and drugs. [source: Orange Book §1.2.4, §2.2.2.2]
  • Trauma-informed, client-centred care. Build environments that promote treatment and recovery capital. [source: TIP 63]

4. Intervention inventory

Part A describes how each medicine is delivered and regulated and its key warnings, at a descriptive level, so you can follow your client's treatment and know what to pass on. It contains no doses, starting, titration, switching or stopping details; those belong to the prescriber. Part B gives the psychotherapist's own interventions.

Part A. How the medicines are delivered

A1. Methadone (opioid use disorder)

  • Purpose: an opioid agonist, given as oral formulations (tablets, oral concentrate), that stabilises people with opioid dependence and reduces illicit use. The US label calls it "a full opioid agonist" and lists three indications: severe long-term pain where alternatives are inadequate, detoxification treatment of opioid addiction, and maintenance treatment of opioid addiction "in conjunction with appropriate social and medical services" (paraphrased). [source: methadone (Dolophine) US prescribing information, revised 6/2021; TIP 63 comparison table]
  • Who delivers it, US: for OUD, methadone is dispensed only by federally certified, accredited opioid treatment programmes (OTPs). OTP practitioners order it; nurses and pharmacists administer and dispense it. Under the 2024 rule a "practitioner" is a professional licensed by the state to prescribe or dispense OUD medicines and authorised to practise in an OTP, but state law still governs scope, and some states restrict nurse practitioners, physician assistants or pharmacists. Observed dosing at the clinic is the starting pattern; the 2024 rule removed the old take-home eligibility criteria and left early take-home access to the treating practitioner's clinical judgement, with patient grievance procedures for disputes. Interim treatment while waiting for full services can now run up to 180 days and is open to all OTPs. New patients can be assessed by audio-visual telehealth for methadone, but not audio-only except narrowly. [source: Federal Register 2024 final rule; TIP 63 table]
  • Who delivers it, UK: prescribed by specialist drug services or primary care within a keyworked care plan under the Orange Book. Attendance and supervision requirements should respect individual circumstances, and the Orange Book warns that stable patients may be over-supervised; it also says there is no justification for arbitrary requirements to attend several appointments before prescribing, and that people well known to a service can often be restarted quickly. Strategic care-plan reviews fall within about three months of starting (no later than six), then six-monthly, and at least yearly once stable. [source: Orange Book §2.2.4, §2.7.2, §2.7.4] Chapter 4 of the Orange Book covers prescribing, choosing between methadone and buprenorphine, supervised consumption (§4.5), reviewing progress, maintenance, detoxification and naltrexone. [source: Orange Book contents] [uncertain: chapter 4's detail on supervised consumption and prescriber competences]
  • Key warnings as sources state them: the US label carries boxed warnings on addiction, abuse and misuse; the Opioid Analgesic REMS (for pain use); life-threatening respiratory depression; accidental ingestion (especially by children); life-threatening QT prolongation; neonatal opioid withdrawal syndrome; interactions with drugs affecting cytochrome P450 enzymes; and use with benzodiazepines or other CNS depressants, including alcohol, which "may result in profound sedation, respiratory depression, coma, and death". For opioid addiction treatment, the boxed warning states that methadone may be dispensed only by certified OTPs under 42 CFR 8.12. Heart rhythm: QT prolongation and serious arrhythmia (torsades de pointes) have occurred; most cases involved large doses for pain, but cases have also occurred at maintenance doses for opioid addiction. The label asks prescribers to monitor closely people with risk factors for a prolonged QT interval (examples given include cardiac hypertrophy, diuretic use, low potassium and low magnesium), a history of conduction abnormalities, or other medicines affecting cardiac conduction, and to look at modifiable factors such as interacting medicines if QT prolongation develops. Starting or stopping other medicines that affect CYP450 enzymes can raise methadone levels to potentially fatal respiratory depression. [source: methadone (Dolophine) US prescribing information, revised 6/2021] Respiratory depression is more likely than with buprenorphine, especially early in treatment or with alcohol or benzodiazepines; stopping abruptly produces marked withdrawal; diversion is low with observed dosing and higher with take-homes, mitigated by a diversion-control plan. [source: TIP 63 table] Safe storage away from children is a safeguarding issue. [source: Orange Book Box 1, storage of drugs; label boxed warning on accidental ingestion] Any ECG schedule is the prescriber's decision. [uncertain: the label excerpt read did not specify one]
  • Watch for and pass on: drowsiness, slurred speech or nodding off in session; new use of alcohol, benzodiazepines or other sedatives; fainting, palpitations or a racing or irregular heartbeat (relevant to the label's QT warning); any new medicine started elsewhere, including antibiotics, antifungals, antidepressants or HIV medicines (the label warns of interactions and QT effects; the prescriber decides what matters); vomiting or diarrhoea that could upset potassium or magnesium; missed doses; signs that medicine at home is not stored safely. Fainting with chest pain, or a suspected overdose, is an emergency. [synthesis grounded in the methadone US prescribing information]

A2. Buprenorphine (opioid use disorder)

  • Purpose: a partial opioid agonist that stabilises opioid dependence with a lower respiratory-depression risk than methadone. The Suboxone label describes buprenorphine as "a partial agonist at the mu-opioid receptor", combined with naloxone (an opioid antagonist) in a sublingual film, indicated for opioid dependence; it "should be used as part of a complete treatment plan that includes counseling and psychosocial support". [source: Suboxone US prescribing information, revised 5/2025; TIP 63 table] The 2024 federal OTP rule separately says medication must not be made conditional on counselling in OTPs. [source: Federal Register 2024]
  • Who delivers it, US: on 12 January 2023 the DEA and SAMHSA announced the immediate elimination of the DATA waiver ("X-waiver"), following the MAT Act in the December 2022 omnibus bill. All clinicians with a current DEA registration that includes Schedule III authority can now prescribe buprenorphine for OUD, with no caps on patient numbers. [source: The Hospitalist, January 2023] Under the MATE Act in the same law, from 27 June 2023 every DEA-registered practitioner must attest, on their next initial or renewal registration, to a one-time eight-hour training on treating and managing patients with opioid or other substance use disorders. Board certification in addiction medicine or addiction psychiatry, or graduation within five years before that date from a curriculum with at least eight hours on the topic, counts as meeting it. [source: ASTRO summary of the DEA's 2023 letter to registrants] [uncertain: the DEA letter itself] Buprenorphine is prescribed in office settings and dispensed by community pharmacies, or given in OTPs, which can start it by audio-visual or audio-only telehealth after an adequate evaluation. Formulations include sublingual or buccal tablets and films and long-acting forms (implant or injection) given by specially trained providers to stabilised patients. [source: Federal Register 2024; TIP 63 table, which predates the waiver removal] [uncertain: which long-acting products are currently marketed in each country]
  • Who delivers it, UK: specialist services or primary care under the Orange Book, as for methadone; the Orange Book's chapter 4 covers choosing between methadone and buprenorphine and supervised consumption. [source: Orange Book contents and §2.2.4] [uncertain: chapter 4]
  • Key warnings: the Suboxone label shows no boxed warning. Its warnings cover: addiction, abuse, misuse and diversion (buprenorphine is Schedule III); life-threatening respiratory and CNS depression, with prescribers advised to consider naloxone; higher overdose risk with benzodiazepines or other CNS depressants, although the label says treatment should not be categorically denied to people taking them; severe, possibly fatal breathing problems if a child swallows it (store out of reach, dispose of unused medicine); neonatal opioid withdrawal syndrome, described as expected and treatable and weighed against untreated opioid addiction in pregnancy; adrenal insufficiency; withdrawal on abrupt stopping (typically milder than with full agonists); hepatitis and liver events, with liver tests at baseline and periodically; allergic reactions; precipitated withdrawal; dental problems (caries, tooth loss), including in people with no dental history, so regular dental care is advised; QTc caution in people with risk factors; impaired driving or machine use, especially early in treatment and after dose changes; and dizziness on standing. [source: Suboxone US prescribing information, revised 5/2025] Precipitated withdrawal can also occur if buprenorphine is started too soon after recent use of other opioids. [source: TIP 63 table and executive summary]
  • Watch for and pass on: a client describing sudden severe withdrawal after a first dose (a frightening experience that can put people off treatment), sedative or alcohol co-use, drowsiness that affects driving, yellowing of skin or eyes, dark urine or abdominal pain, tooth or gum problems (encourage a dentist visit), dizziness or fainting on standing, selling or sharing medicine, medicine stored where children can reach it, missed pharmacy pick-ups. [synthesis grounded in the Suboxone US prescribing information]

A3. Naltrexone (opioid and alcohol use disorders)

  • Purpose: an opioid antagonist. In opioid use disorder it blocks opioid effects; in alcohol dependence it reduces the rewarding effects of alcohol and craving. [source: TIP 63; GG&C ADRS guideline]
  • Who delivers it: US: any prescriber can offer it, in office or clinic settings, as an oral tablet or an extended-release intramuscular injection. UK: prescribed by alcohol and drug services for relapse prevention in alcohol dependence, alongside psychosocial support, with a patient treatment card. [source: TIP 63; GG&C ADRS guideline]
  • Key warnings: an adequate opioid-free period is required before starting; otherwise severe precipitated withdrawal can occur. It blocks opioid-containing medicines (including some cough and anti-diarrhoeal products). People must not take large amounts of opioids to overcome the blockade; this can cause acute, possibly fatal overdose. After stopping, people may be more sensitive to opioids, raising overdose risk. It is avoided in people who are opioid-dependent, on opioid substitution, or have a positive opioid screen, and in acute hepatitis or severe liver impairment. Listed side effects include liver-enzyme rises and injection-site pain. TIP 63 lists "vulnerability to opioid overdose" among naltrexone's risks. [source: GG&C ADRS guideline; TIP 63 executive summary and table]
  • Watch for and pass on: talk of "testing" the blockade, a missed injection followed by return to use, pain needing medical treatment (the client should tell any doctor they take naltrexone), jaundice or abdominal pain. [synthesis]

A4. Acamprosate (alcohol dependence)

  • Purpose: an anti-craving medicine to help maintain abstinence. [source: GG&C ADRS guideline]
  • Who delivers it: prescribed by alcohol services or primary care, typically under shared-care arrangements, alongside psychosocial support. [source: GG&C ADRS guideline] NICE CG115, as summarised by secondary sources: for moderate and severe alcohol dependence, after successful withdrawal, consider offering acamprosate or oral naltrexone combined with an individual psychological intervention (cognitive behavioural, behavioural or social network and environment-based therapy) focused on alcohol; medicines should be given by competent specialist staff. [source: Drug and Alcohol Findings summary of CG115; North Yorkshire GP abstinence-therapy service specification citing CG115 §1.3.6] [uncertain: the NICE recommendations page itself is not drawn on, so exact wording and numbering are unconfirmed]
  • Key warnings: described as low-risk with few side effects or interactions. It is avoided in known hypersensitivity, severe liver impairment and significant kidney impairment, used in pregnancy only if benefit outweighs risk, and avoided in breastfeeding. Common side effects include gastrointestinal upset, rash and reduced libido. Routine blood tests are not required; drinking and psychosocial wellbeing are reviewed. [source: GG&C ADRS guideline]
  • Watch for and pass on: persistent gut upset or rash, mood change, and whether the client is drinking (relapse is information for the prescriber, not a reason to judge). [synthesis]

A5. Disulfiram (alcohol dependence)

  • Purpose: US labelling describes it as "an aid in the management of selected chronic alcohol patients who want to remain in a state of enforced sobriety", used within supportive and psychotherapeutic treatment; it is not a cure. The NHS guideline describes it as working mainly as a psychological deterrent. [source: disulfiram prescribing information; GG&C ADRS guideline]
  • Who delivers it: prescribed by specialist services. In the NHS guideline supervision may be by a community pharmacy, a service day unit, or a responsible family member or carer who knows the signs of a reaction and agrees to contact the service if one happens or the client stops. Clients carry a treatment card. [source: GG&C ADRS guideline] As paraphrased from NICE CG115 §1.3.6, disulfiram is considered for people whose goal is abstinence when acamprosate and naltrexone are not suitable, or who prefer it and understand the relative risks; service users and family should be told about the reaction with alcohol, including traces in some foods and sprays. [source: North Yorkshire GP abstinence-therapy service specification citing CG115] [uncertain: NICE wording]
  • Boxed warning: disulfiram "should never be administered to a patient when he is in a state of alcohol intoxication" or without the patient's full knowledge; relatives should be told this. [source: disulfiram prescribing information]
  • The disulfiram–alcohol reaction: even small amounts of alcohol can trigger flushing, throbbing in the head and neck, headache, breathing difficulty, nausea, vomiting, sweating, fast heartbeat, low blood pressure, fainting, confusion and blurred vision; severe reactions can involve cardiovascular collapse, arrhythmias, heart attack, convulsions, unconsciousness and death. The reaction can occur for up to about two weeks after the last dose. Hidden alcohol (sauces, vinegars, cough medicines, aftershave, perfumes, aerosols) can trigger it. The NHS guideline tells clients who drink on disulfiram to attend an emergency department and tell their worker. [source: disulfiram prescribing information; GG&C ADRS guideline]
  • Other warnings: severe, sometimes fatal hepatitis has been reported; early signs include fatigue, jaundice and dark urine, and liver tests are done at baseline and follow-up. Contraindications include recent alcohol or alcohol-containing products, recent metronidazole or paraldehyde, severe heart disease and psychoses. [source: disulfiram prescribing information]
  • Watch for and pass on: any drinking while on it, feeling unwell, fever or yellowing, pressure from a partner or family to take it (consent must be the client's own), psychotic symptoms. [synthesis grounded in the label's full-knowledge requirement]

A6. Nicotine replacement therapy, varenicline and other stop-smoking medicines

  • Purpose: to reduce withdrawal and craving during a quit attempt. [source: NICE QS207]
  • What NICE recommends (England): behavioural support combined with a medicine or e-cigarette is more likely to succeed. Options are cytisinicline, combined short- and long-acting NRT, varenicline, or nicotine-containing e-cigarettes (age-dependent), chosen with the person's preferences. Cytisinicline, varenicline and bupropion should not be offered in pregnancy, while breastfeeding, or to under-18s; cytisinicline not to people aged 66 and over. Delivered by primary care and NHS stop-smoking services with staff trained to NCSCT standards. People with severe mental health conditions who need extra help "should be offered support by a specialist adviser with mental health expertise". [source: NICE QS207 statement 3, citing NG209 recs 1.12.1, 1.12.2, 1.13.1]
  • Varenicline warning history (US): the FDA removed the boxed warning on serious neuropsychiatric events from varenicline and bupropion after reviewing a large clinical trial, concluding that the risk to mood, behaviour or thinking is lower than previously suspected. The risk is still described as present, especially for people currently or previously treated for depression, anxiety disorders or schizophrenia; the Medication Guide continues with every prescription. [source: UW CTRI, January 2017]
  • Watch for and pass on: new or worsening low mood, agitation, unusual thoughts or behaviour, suicidal thinking, and sleep disturbance; also any change in psychiatric medicine effects after stopping smoking (smoking can affect some medicine levels, so the prescriber should know about a quit attempt). [synthesis] [uncertain: the smoking–medicine interaction point was not in the sources; it is a reason to inform the prescriber, not to change anything]

A7. Naloxone and overdose awareness

  • Purpose: naloxone is the standard emergency treatment for opioid overdose and acts quickly to reverse it; in people who are dependent on opioids it can cause severe withdrawal. [source: FDA news release, 29 March 2023, as republished by BioSpace] [uncertain]
  • Delivery: in the US, on 29 March 2023 the FDA approved Narcan naloxone nasal spray (Emergent BioSolutions) for sale without a prescription, for example in drug stores, convenience and grocery stores, petrol stations and online; the manufacturer sets timing and price, and other naloxone formulations and strengths remain prescription-only. [source: FDA news release, 29 March 2023, as republished by BioSpace] The Suboxone label also asks prescribers to consider naloxone for people on buprenorphine. [source: Suboxone US prescribing information] UK guidance says carers should be given information on overdose, naloxone availability and safe storage of medicines, and lists overdose and naloxone training among opportunistic interventions. [source: Orange Book §2.7.4, §2.7.12] [uncertain: Orange Book §6.4 on naloxone is not drawn on]
  • Who is at risk: people who have used opiates in treatment or the criminal justice system are "six times more likely to die prematurely" than the general population; risk peaks soon after leaving treatment or prison when someone has recently been abstinent; risk rises when opioids are combined with alcohol or benzodiazepines, and after stopping naltrexone. [source: Orange Book §1.2.3, §2.2.6; TIP 63; GG&C ADRS]
  • Therapist level: know where clients and families can get naloxone locally, encourage carrying it and telling others where it is, and know that the response to suspected overdose is to call emergency services and follow their instructions. [synthesis at public-health level]

Part B. The psychotherapist's interventions

The sources set the frame (counsellors work with clients on medication as with any client, communicate with prescribers, and build client-centred, trauma-informed settings) but give little step-by-step procedure for a psychotherapist. The steps below are therefore largely [synthesis] built on that frame; sourced points are tagged. [source for the frame: TIP 63 Part 4 as summarised in the executive summary]

B1. Screening and recognising when to suggest a medical review

  • Purpose: to notice dependence that medicines can help, and physical or psychiatric warning signs that need a prescriber now.
  • Steps: (1) Ask routinely about opioids (including prescribed painkillers), alcohol, tobacco and sedatives at intake and when mood or functioning changes. (2) Note withdrawal, loss of control, failed attempts to cut down, overdoses, and injecting. (3) Note urgent signs: recent overdose, mixing opioids with alcohol or benzodiazepines, recent release from prison or end of a withdrawal programme, drinking on disulfiram, jaundice, or alcohol withdrawal that is severe (shaking, confusion, seizures). (4) Separate routine referral ("medicines exist, worth an assessment") from same-day medical contact or emergency services. [synthesis; risk points from Orange Book §2.2.6, disulfiram label, GG&C ADRS]
  • Example language (illustrative): "Some of what you describe, the shaking in the mornings and needing a drink to settle, is the kind of thing a doctor can help with safely. Would you be open to me helping you get an assessment?"
  • Watch for: your own reluctance to ask about substance use; clients minimising. It is working when substance use becomes a routine, unembarrassed topic.

B2. Referral and warm handover

  • Purpose: to connect the client to a prescriber, OTP, specialist service, primary care or stop-smoking service quickly.
  • Steps: (1) Know the local routes: in the US, OTPs for methadone, any DEA-registered clinician with Schedule III authority for buprenorphine, any prescriber for naltrexone; in the UK, specialist drug and alcohol services, GPs and NHS stop-smoking services. (2) Ask permission to share relevant history. (3) Make the call together in session where possible. (4) Prepare the client for what assessment involves (history, drug testing, physical health checks) without predicting what the prescriber will decide. (5) Follow up at the next session. [source for routes: The Hospitalist 2023; TIP 63; NICE QS207; the rest synthesis]
  • Example language (illustrative): "I can't advise you on medication, that's the doctor's job, but I can help you get there. Shall we ring them now while you're here?"
  • Watch for: long waits (US interim treatment may be available, and telehealth starts are allowed in some cases, see A1–A2); client fear of being judged; practical barriers such as travel to a daily-dosing clinic. It is working when the client attends.

B3. Collaborative care with the prescriber or treatment programme

  • Purpose: to keep medication and psychosocial treatment joined up. TIP 63 describes ongoing communication with prescribers so that clients get the full benefit of both. [source: TIP 63]
  • Steps: (1) Get written consent for two-way information sharing, naming what will be shared. In the US, records that identify someone as a patient of a federally assisted substance use disorder programme are protected by 42 CFR Part 2. Under the 2024 final rule (announced 8 February 2024; compliance by 16 February 2026), a patient can give one consent for all future uses for treatment, payment and health care operations, after which HIPAA-covered recipients may redisclose under HIPAA rules; records still cannot be used in civil, criminal, administrative or legislative proceedings against the patient without specific consent or a court order; and "SUD counseling notes" kept apart from the record need their own specific consent, like psychotherapy notes under HIPAA. Breaches follow HIPAA breach-notification rules. Find out whether the programme you work with is Part 2-covered and use its consent forms; take legal or compliance advice on specifics. [source: HHS fact sheet on the 2024 Part 2 final rule] (2) Agree a contact route and what each side will flag (overdose, relapse, safeguarding, suicide risk, side effects). (3) Send brief updates focused on function and risk, not session content. (4) In the UK, link with the keyworker and care plan reviews; in US OTPs, with the counsellor and the individual plan of care. (5) Bring the client's own goals into those reviews. [source: Orange Book §2.2.4; Federal Register 2024 on plans of care; rest synthesis]
  • Example language (illustrative): "It helps if your prescriber and I aren't working in separate boxes. Could I let them know that your sleep has got worse since the change, and that you want to talk to them about it?"
  • Watch for: splitting (client tells each professional different things), sharing more than consented, the therapist being drawn into medication decisions. Working when both sides know the plan and the client feels it is one team.

B4. Psychoeducation about the medicines

  • Purpose: to give accurate, neutral information so the client can take part in decisions, and to correct myths.
  • Steps: (1) Explain in plain words what each medicine is for (Part A). (2) Correct myths with sources: medication-supported recovery is recovery (TIP 63); medication is not conditional on counselling in US OTPs (Federal Register 2024); disulfiram only works if the person consents and knows they are taking it (label). (3) Explain the main warnings at the level sources give them: precipitated withdrawal, the disulfiram–alcohol reaction and hidden alcohol, overdose risk after loss of tolerance, naltrexone blocking opioid painkillers. (4) Refer every specific question about dose, timing or suitability to the prescriber. (5) Offer written information from the service or official patient leaflets. [source as tagged; structure synthesis]
  • Example language (illustrative): "One thing worth knowing: if someone has been off opioids for a while, their body loses tolerance, so an amount they used to take can now stop their breathing. That's why the time after stopping treatment is the riskiest."
  • Watch for: information overload; the client hearing information as advice. It is working when the client can explain the main risks in their own words and brings questions to the prescriber.

B5. Addressing stigma

  • Purpose: stigma, including from professionals, families and mutual-aid groups, keeps people away from effective treatment.
  • Steps: (1) Use person-first language and medical terms ("medication", "recurrence", "withdrawal" rather than labels); the 2024 rule replaced stigmatising terms such as "detoxification". (2) Explore self-stigma ("swapping one drug for another") with curiosity, then share what official sources say. (3) Help the client prepare for stigmatising responses from family, employers or groups, including choosing groups that accept medication. (4) Check your service's documents and attitudes. [source: TIP 63; Federal Register 2024; Orange Book §2.7.1; steps synthesis]
  • Example language (illustrative): "You said you feel you're 'not really clean' on buprenorphine. Can we look at where that idea comes from? The national guidance actually counts people on medication as in recovery."
  • Watch for: your own beliefs leaking into tone. Working when the client speaks about their medication without shame.

B6. Supporting informed consent and shared decision-making

  • Purpose: to help the client weigh options and bring their values and questions to the prescriber, whose decision it is with the client. The 2024 rule "fosters greater shared decision-making". [source: Federal Register 2024]
  • Steps: (1) Ask what the client knows and wants. (2) Help list their questions for the prescriber (risks, how treatment fits work and family, what happens if they miss doses, what happens if they want to stop). (3) Explore values ("what matters most"). (4) Rehearse raising concerns with the prescriber. (5) For disulfiram, check consent is free and full, since the label requires full knowledge and the NHS guideline involves a supervising carer. (6) Do not express a preference for a particular medicine. [source as tagged; steps synthesis]
  • Example language (illustrative): "It's your decision with your doctor. What would you want to ask them so you feel you understand the choice?"
  • Watch for: the client looking to you for the decision; coercion by partners, courts or employers. Working when the client attends the prescriber with their own questions.

B7. Motivational work on ambivalence about medication and adherence (never advising a change)

  • Purpose: to help the client explore mixed feelings about starting, continuing or stopping a medicine, while the decision and any change go through the prescriber. Motivational interviewing techniques are part of UK keyworking. [source: Orange Book §3.2]
  • Steps: (1) Reflect both sides of the ambivalence. (2) Explore the client's own reasons and goals. (3) Ask about practical barriers (daily attendance, pharmacy hours, side effects, stigma). (4) If the client is thinking of stopping or is not taking it as prescribed, do not argue or advise; express that the prescriber needs to know and help them raise it, because stopping without a plan can bring withdrawal and, for opioids, overdose risk. (5) Summarise and agree a next step that involves the prescriber. [synthesis]
  • Example language (illustrative): "Part of you is fed up with going to the clinic every day, and part of you is scared of what happens without it. Both make sense. This is exactly the kind of thing to take to your prescriber. Would it help to plan what you'd say?"
  • Watch for: the righting reflex (pushing the client to stay on or come off); hidden non-adherence. Working when the client discusses doubts openly with both you and the prescriber.

B8. Monitoring and passing on side effects and warning signs

  • Purpose: you often see the client more than the prescriber does; noticing and passing on warning signs is a safety task.
  • Steps: (1) Keep a short list of each client's medicine and its warning signs (Part A). (2) Ask briefly each session about sleep, mood, sedation, physical health and substance use. (3) For urgent signs (suspected overdose, a severe disulfiram–alcohol reaction, collapse, chest pain, confusion), call emergency services. For same-day concerns (jaundice or dark urine on disulfiram or naltrexone, drinking on disulfiram, heavy sedative co-use, new suicidal thinking), contact the prescriber or service that day; the NHS guideline tells clients who drink on disulfiram to attend an emergency department. For routine concerns, encourage the client to raise them and, with consent, send a note. (4) Record what you passed on and to whom. [source for warning signs: disulfiram label; GG&C ADRS; TIP 63; CTRI; steps synthesis]
  • Example language (illustrative): "You've mentioned feeling very drowsy since you started taking the sleeping tablets your friend gave you. Mixing those with your methadone can be dangerous. I'd like us to call the clinic today. Can we do that together?"
  • Watch for: reassuring when you should escalate, or interpreting symptoms yourself. Working when concerns reach the prescriber quickly and the client sees you as an ally, not an informer.

B9. Integrating psychosocial treatment

  • Purpose: to deliver or link to the psychosocial treatments that sources recommend alongside medication.
  • Named options in the sources: keyworking with motivational techniques; brief motivational interventions; contingency management and family and couples interventions ("There is a strong evidence base", Orange Book §3.1); the community reinforcement approach; formal psychotherapy for issues that impede change and for co-occurring depression or anxiety; active linkage to mutual aid (12-Step, SMART Recovery). [source: Orange Book §3.1–3.2 and Table 1] For alcohol, CG115 (as summarised) pairs acamprosate or naltrexone with cognitive behavioural, behavioural or social network and environment-based therapy; for 10–17-year-olds it advises individual CBT where comorbidity is low and support good, and multi-component family therapy otherwise; and for co-occurring depression or anxiety it advises treating the alcohol misuse first and reassessing mood after three to four weeks of abstinence. [source: Drug and Alcohol Findings summary of CG115; GG&C ADRS guideline] [uncertain: NICE recommendation numbers not confirmed] Delivery details of each named therapy are covered in their own guides.
  • Steps: (1) Formulate the client's substance use together with mental health, trauma, relationships and social needs. (2) Choose the psychosocial approach with the client and agree how it fits around medication appointments. (3) Use the stability medication offers to work on what drives use (craving cues, emotions, relationships, housing, work). (4) Treat co-occurring conditions in a coordinated plan with the prescriber. (5) Help the client find mutual-aid groups that accept medication. (6) Keep the work going if the client declines medicine or psychosocial work: the NHS guideline allows medicine without psychosocial engagement after informing the client of the benefits of combined treatment. [source: GG&C ADRS; Orange Book §7.9; steps synthesis]
  • Example language (illustrative): "Now that the cravings are less loud, we've got room to look at the evenings, which you said were when things used to fall apart."
  • Watch for: therapy that ignores the medication, or medication with no psychosocial attention. Working when goals move from crisis towards resilience and recovery milestones. [source: Orange Book §2.2.3]

B10. Crisis and overdose-risk planning

  • Purpose: to reduce the chance of overdose and suicide, which are linked in this population. [synthesis]
  • Steps: (1) Assess overdose risk factors at intake and at each transition: recent abstinence or loss of tolerance, leaving prison, hospital or residential treatment, stopping naltrexone or OUD medication, mixing opioids with alcohol or sedatives, using alone, previous overdose. (2) Write a joint plan: who to call, where naloxone is kept, who else knows, not using alone, rapid re-entry to treatment (the Orange Book recommends aftercare, rapid re-entry and mutual aid). (3) Combine it with a standard suicide safety plan: warning signs, coping strategies, contacts, professional and crisis lines, and lethal-means counselling (safe storage of medicines, including asking the prescriber or pharmacist about safe storage and disposal; the Orange Book covers safe storage). (4) Agree with the client what you will tell the prescriber if risk rises. (5) Review after any overdose, relapse or crisis. [source: Orange Book §2.2.6, §2.7.12; GG&C ADRS; suicide-planning steps synthesis following standard practice]
  • Example language (illustrative): "You're leaving the residential unit next week. Your tolerance will be lower than it used to be, which makes this a high-risk time. Can we make a plan now for what you'd do if things got hard, including where you'd keep naloxone and who you'd call?"
  • Watch for: the client hearing the plan as you expecting relapse (frame it as safety, like a seatbelt); intentional overdose hidden as accident. Working when the client can state the plan and someone in their life knows it.

B11. Working with families and carers

  • Purpose: families and carers are a valuable resource when the client agrees, and they need information to stay safe. [source: Orange Book §1.2.5.5, §2.7.12]
  • Steps: (1) With consent, invite a family member to a session. (2) Provide information on overdose, naloxone and safe storage of medicines. (3) For disulfiram, make sure supervising carers understand the reaction and when to contact the service, and that the medicine is never given without the client's knowledge. (4) Address family stigma about medication. (5) Assess and act on risks to children, following safeguarding procedures. (6) Consider family or couples-based interventions. [source: Orange Book §1.2.4, §2.7.12; disulfiram label; GG&C ADRS]
  • Example language (illustrative): "Your partner wants to help. Would it be useful for them to come once, so we can go through what the disulfiram reaction looks like and what to do?"
  • Watch for: carers becoming controllers or using medicine as punishment; domestic abuse. Working when family support feels to the client like help, not surveillance.

B12. Transitions and support after treatment ends

  • Purpose: to hold continuity at the moments of highest risk, such as moving between services, prison release, ending a medicine with the prescriber, or a discharge.
  • Steps: (1) Find out early about planned transitions. (2) Coordinate with the prescriber and the next service so there is no gap; ask whether interim or telehealth options exist (US OTPs). (3) Repeat overdose-risk planning (B10). (4) Plan for the psychological side of ending a medicine (fear, identity, craving) while the prescriber manages the medical side. (5) Offer continued or booster sessions and a clear route back into treatment if use recurs. [source: Orange Book §2.2.6; Federal Register 2024 on interim treatment and telehealth; rest synthesis]
  • Example language (illustrative): "If you and your doctor decide to finish the medication, I'd like us to keep meeting through that time, and to agree how you'd get straight back into treatment if you needed to."
  • Watch for: clients dropping out at transfer points. Working when there is no week without contact through the transition.

B13. Supporting tobacco cessation in therapy

  • Purpose: to help clients stop smoking with the combination NICE recommends (behavioural support plus medicine or e-cigarette).
  • Steps: (1) Ask about smoking routinely, including with clients in addiction or mental health care. (2) Refer to primary care or NHS stop-smoking services (or local equivalents); for people with severe mental illness, ask for an adviser with mental health expertise. (3) Integrate quit support into therapy (triggers, stress, identity, relapse prevention). (4) Tell the prescriber about a quit attempt and pass on mood or behaviour changes, especially for clients with a history of depression, anxiety or schizophrenia. [source: NICE QS207; CTRI on varenicline; steps synthesis]
  • Example language (illustrative): "People who combine support with a stop-smoking medicine or e-cigarette do better. The stop-smoking service can talk you through the options. Shall we make a referral?"
  • Watch for: assuming smoking is "the least of their problems"; mood dips during quitting. Working when the client makes a supported quit attempt.

5. Handling problems

  • Client asks you whether to start, stop or change a medicine. Do not advise. Acknowledge the question, explore what's behind it, and help them take it to the prescriber, offering to contact the prescriber with consent. [synthesis]
  • Client wants to stop OUD medication suddenly (e.g. under family or group pressure). Explore ambivalence (B7) and the source of the pressure (B5); explain at public-health level that stopping is a decision to make with the prescriber and that loss of tolerance raises overdose risk; encourage an urgent prescriber conversation; do overdose planning (B10). [synthesis; risk from Orange Book §2.2.6]
  • Recurrence of use while on medication. Treat it as information about a chronic condition, not failure; inform the prescriber with consent; review the care plan. For alcohol, the NHS guideline says relapse should be considered in context and decisions about continuing or changing treatment made with medical staff. [source: GG&C ADRS; TIP 63]
  • Drinking on disulfiram. Treat as a medical concern: the guideline directs clients to an emergency department and to tell their worker; suitability is then reassessed with the prescriber. Explore without shaming what happened. [source: GG&C ADRS]
  • "Testing" the naltrexone blockade or using after a missed dose. Name the overdose danger plainly (large amounts to overcome the block can be fatal; sensitivity rises after stopping); inform the prescriber; overdose plan. [source: GG&C ADRS]
  • Precipitated withdrawal put the client off buprenorphine or naltrexone. Validate the experience; encourage the client to discuss it with the prescriber, who can explain what happened and what options exist. [source for the phenomenon: TIP 63; response synthesis]
  • Non-adherence and missed appointments. Explore practical barriers (daily attendance, travel, pharmacy hours, work); help the client raise them with the service, which in the US can use clinical judgement on take-homes and telehealth; avoid making therapy conditional on medication or vice versa. [source: Federal Register 2024; response synthesis]
  • Diversion or selling medicine. Explore the reasons (money, helping a friend); explain risks to others, including children; follow your confidentiality and safeguarding rules; encourage disclosure to the prescriber. [synthesis; diversion risk from TIP 63]
  • Coerced treatment (court, family, employer). Separate the client's goals from others'; protect informed consent, especially for disulfiram, which must not be given without the patient's full knowledge. [source: disulfiram label; response synthesis]
  • Stigma from the therapist's own service or a mutual-aid group. Name it, help the client find accepting groups, and raise the issue within your service. [source: Orange Book §2.7.1; synthesis]
  • Rupture with the prescriber or programme (e.g. over take-home decisions). Help the client prepare to raise it calmly; US OTPs must have complaint and grievance procedures for take-home disputes; avoid taking sides on medical decisions. [source: Federal Register 2024; synthesis]
  • Rupture with the therapist after you passed on a concern. Name the rupture, explain why you acted (safety, agreed consent), and repair; agree in advance what you will share (B3) to prevent this. [synthesis]
  • Overwhelm or sedation in session. Slow down and ground; if the client seems intoxicated or over-sedated, prioritise physical safety, do not do deep emotional work, and contact the service or emergency services as needed. [synthesis]
  • Mood changes during a quit attempt on varenicline. Pass on promptly to the prescriber; the label still warns of neuropsychiatric risk, particularly with a mental health history. [source: CTRI on FDA labelling]
  • Suicidal thinking. Follow standard risk assessment and safety planning (B10), with lethal-means counselling about safe storage of medicines, and inform the prescriber. [synthesis following standard practice]
  • Not addressed in the sources (all synthesis): pain management needs while on naltrexone (ask the client to make sure any doctor or dentist knows), pregnancy (refer to the prescriber and maternity services promptly), and clients using several of these medicines at once (the prescriber coordinates; your role is to keep a current list and pass on concerns).

Sources

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