#223 Buprenorphine-Naloxone (Suboxone®) for Pharmaceutical Opioid Use Disorder
CLINICAL QUESTION
Is buprenorphine (with or without naloxone) effective as maintenance therapy in pharmaceutical opioid use disorder?
BOTTOM LINE
Retention in treatment at 15 weeks was seen in 75% taking buprenorphine compared to 26% in detoxification and/or counselling, with 37% reporting ongoing substance use compared to 60% in control. Outcomes between buprenorphine and methadone in this population are similar. The evidence is at moderate to high risk of bias.
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EVIDENCE
Systematic review of six randomized controlled trials (RCTs) of 607 patients with “pharmaceutical” opioid dependence (23% female, mean age 32, mean study duration 15 weeks). Source of opioids often not described (example prescribed versus diverted).1
- Comparing buprenorphine to detoxification and/or psychological treatment:
- Retention in treatment (three RCTs, 247 patients): 75% versus 26% control, Number Needed to Treat (NNT)=3.
- Self-reported substance use (three RCTs, 204 patients): 37% versus 60% control, NNT=5.
- End of treatment opioid-positive drug screen (three RCTs, 206 patients): 40% versus 61% control, NNT=5.
- No difference: Days of unsanctioned opioid use or drug-related risk behaviours.
- Unspecified adverse effects (one RCT, 53 patients): 0% versus 8% control.
- Comparing buprenorphine to methadone:
- No difference: Retention in treatment, substance use, risk behaviours, health scales or adverse effects.
- No data on mortality, quality of life, function, or overdose reported.1
- Limitations: All RCTs open-label; high drop-out rates; one study only included illicit buprenorphine users.
- Systematic review (five RCTs):
- No opioid-related deaths (four RCTs);2
- Four deaths (placebo) versus zero (buprenorphine) after one year (one RCT, 40 patients).2,3
- Versus methadone: No difference in mortality (one RCT, secondary analysis).4
- Adding naloxone (an opioid antagonist) to buprenorphine has little impact orally due to poor absorption but can cause withdrawal if crushed for IV use.5
- In Ontario, 33% of people with opioid-related death had active opioid prescriptions.6
- 58% of those had only prescribed opioids on post-mortem toxicology.6
- Observational studies (included heroin users and multiple confounders) report:
- Decreased mortality with opioid agonist therapy.7,8
- Lower mortality with buprenorphine/naloxone compared to methadone.9
- In heroin users, methadone results in more treatment retention than buprenorphine, NNT=4-10 at 12-24 weeks.2,10
- Buprenorphine/naloxone dosing information available online.11
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