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Randomized Controlled Trial
. 2022 Oct 1:239:109604.
doi: 10.1016/j.drugalcdep.2022.109604. Epub 2022 Aug 17.

Buprenorphine/naloxone and methadone effectiveness for reducing craving in individuals with prescription opioid use disorder: Exploratory results from an open-label, pragmatic randomized controlled trial

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Free article
Randomized Controlled Trial

Buprenorphine/naloxone and methadone effectiveness for reducing craving in individuals with prescription opioid use disorder: Exploratory results from an open-label, pragmatic randomized controlled trial

Christina McAnulty et al. Drug Alcohol Depend. .
Free article

Abstract

Background: Craving reduction is an important target in the treatment of prescription-type opioid use disorder (POUD). In this exploratory analysis, we compared the effectiveness of BUP/NX flexible model of care relative to methadone for craving reduction in individuals with POUD.

Methods: We analyzed data from a multicentric, pragmatic, 24-week open-label randomized controlled trial conducted in participants with POUD (N = 272) who were randomly assigned to BUP/NX model of care with flexible take-home dosing (n = 138) or the standard model of care with closely supervised methadone (n = 134). Treatments were prescribed and administered according to local guidelines, in diverse clinical settings. Craving was measured using the Brief Substance Craving Scale at baseline, week 2, 6, 10, 14, 18 and 22.

Results: Cravings decreased in both treatment groups over 22 weeks (BUP/NX adjusted mean difference = -5.52, 95% CI = -6.91 to -4.13; methadone adjusted mean difference = -3.95, 95% CI = -5.28 to -2.63; p < 0.001), and were overall lower in the BUP/NX group (adjusted mean = 4.04, 95% CI = 3.43-4.64) than the methadone group (adjusted mean = 5.13, 95% CI = 4.51-5.74; p < 0.001). The time by treatment group interaction (favoring BUP/NX) was statistically significant at week 2 (adjusted mean difference = -1.58, 95% CI = -3.13 to -0.03; p = 0.041).

Conclusions: Compared to the standard methadone model of care, flexible take-home dosing of BUP/NX was associated with lower craving in individuals with POUD. These findings can contribute to guiding shared decision-making regarding OAT treatment in this population.

Trial registration: ClinicalTrials.gov NCT03033732.

Keywords: Buprenorphine/naloxone; Craving; Methadone; Opioid; Opioid-related disorders.

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Conflict of interest statement

Conflict of interest DJA is supported by a research scholar award from the Fonds de Recherche du Québec en Santé. MES is supported by a Michael Smith Foundation for Health Research and St. Paul’s Foundation Scholar Award. CM received financial support from l'Institut universitaire sur les dépendances for the writing and publication of the article. GB received funding for an accelerated passage from master’s to doctorate scholarship from the Université de Montréal. JB is partly financed by a Tier 1 Canada Research chair in Addiction Medicine and receives or has received support from Gilead Sciences and AbbVie, outside of this study. BLF is supported by a clinician scientist award from the Department of Family and Community Medicine and by the Addiction Psychiatry Chair of the Department of Psychiatry, University of Toronto. BLF also receives or has received support from Pfizer Global Research Awards in Nicotine Dependence (GRAND) Program, Brainsway, Bioprojet, Alkermes, Canopy, ACS, and non-financial support from Aurora for work outside this study. MES is supported by a Michael Smith Foundation for Health Research and St. Paul’s Foundation Scholar Award. BLF has a relationship with Indivior that includes consulting and funding grants. SM has a relationship with Indivior that includes consulting. MES has received funding grants from Indivior. AT has a family member who works for ViiV USA. The authors declare no other conflict of interest.

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