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

Drug Alcohol Depend. 2022 Oct 1:239:109604. doi: 10.1016/j.drugalcdep.2022.109604. Epub 2022 Aug 17.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Buprenorphine* / therapeutic use
  • Buprenorphine, Naloxone Drug Combination / therapeutic use
  • Craving
  • Humans
  • Methadone / therapeutic use
  • Naloxone / therapeutic use
  • Narcotic Antagonists / therapeutic use
  • Opiate Substitution Treatment / methods
  • Opioid-Related Disorders* / drug therapy
  • Opioid-Related Disorders* / rehabilitation
  • Prescriptions

Substances

  • Buprenorphine, Naloxone Drug Combination
  • Narcotic Antagonists
  • Naloxone
  • Buprenorphine
  • Methadone

Associated data

  • ClinicalTrials.gov/NCT03033732