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Buprenorphine treatment formulations: Preferences among persons in opioid withdrawal management.

ABSTRACT: BACKGROUND:In the current study, we examined factors predicting willingness to receive buprenorphine treatment and preferences for various buprenorphine formulations (oral, injection, implant) among persons in opioid withdrawal management. METHODS:Participants were three hundred thirty-eight persons entering brief inpatient opioid withdrawal management programs at two sites. We used t-tests and Pearson ?2 - tests of independence to compare participants willing and unwilling to be prescribed buprenorphine in the future. Among persons willing to receive buprenorphine, we used multinomial logistic regression to estimate the adjusted effects of potential correlates of type of buprenorphine formulation preferred. RESULTS:Participants averaged 33.9 (±9.5) years of age, 70.4% were male, 82.8% were White, and 11.0% were Latino/a. In all, 55.6% of participants had been prescribed buprenorphine in the past, and 54.7% were willing to use prescribed buprenorphine in the future. Those reporting past month illicit buprenorphine use and prior overdose were more willing to use prescribed buprenorphine. Of these (n?=?180), most preferred daily buprenorphine formulations (tablet or film) (48.6%) over a weekly or monthly injection (23.1%) or bi-annual implant (28.3%). CONCLUSIONS:Past buprenorphine prescription does not predict future willingness to restart. Among those willing to use buprenorphine, newer formulations of buprenorphine appealed to more than half of the participants.

SUBMITTER: Kenney SR

PROVIDER: S-EPMC6152924 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Buprenorphine treatment formulations: Preferences among persons in opioid withdrawal management.

Kenney Shannon R SR Anderson Bradley J BJ Bailey Genie L GL Stein Michael D MD

Journal of substance abuse treatment 20180828

<h4>Background</h4>In the current study, we examined factors predicting willingness to receive buprenorphine treatment and preferences for various buprenorphine formulations (oral, injection, implant) among persons in opioid withdrawal management.<h4>Methods</h4>Participants were three hundred thirty-eight persons entering brief inpatient opioid withdrawal management programs at two sites. We used t-tests and Pearson χ2 - tests of independence to compare participants willing and unwilling to be ...[more]

PMID: 30243418

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Project description:Importance:Buprenorphine treatment for opioid use disorder may be improved by sustained-release formulations. Objective:To determine whether treatment involving novel weekly and monthly subcutaneous (SC) buprenorphine depot formulations is noninferior to a daily sublingual (SL) combination of buprenorphine hydrochloride and naloxone hydrochloride in the treatment of opioid use disorder. Design, Setting, and Participants:This outpatient, double-blind, double-dummy randomized clinical trial was conducted at 35 sites in the United States from December 29, 2015, through October 19, 2016. Participants were treatment-seeking adults with moderate-to-severe opioid use disorder. Interventions:Randomization to daily SL placebo and weekly (first 12 weeks; phase 1) and monthly (last 12 weeks; phase 2) SC buprenorphine (SC-BPN group) or to daily SL buprenorphine with naloxone (24 weeks) with matched weekly and monthly SC placebo injections (SL-BPN/NX group). Main Outcomes and Measures:Primary end points tested for noninferiority were response rate (10% margin) and the mean proportion of opioid-negative urine samples for 24 weeks (11% margin). Responder status was defined as having no evidence of illicit opioid use for at least 8 of 10 prespecified points during weeks 9 to 24, with 2 of these at week 12 and during month 6 (weeks 21-24). The mean proportion of samples with no evidence of illicit opioid use (weeks 4-24) evaluated by a cumulative distribution function (CDF) was an a priori secondary outcome with planned superiority testing if the response rate demonstrated noninferiority. Results:A total of 428 participants (263 men [61.4%] and 165 women [38.6%]; mean [SD] age, 38.4 [11.0] years) were randomized to the SL-BPN/NX group (n = 215) or the SC-BPN group (n = 213). The response rates were 31 of 215 (14.4%) for the SL-BPN/NX group and 37 of 213 (17.4%) for the SC-BPN group, a 3.0% difference (95% CI, -4.0% to 9.9%; P < .001). The proportion of opioid-negative urine samples was 1099 of 3870 (28.4%) for the SL-BPN/NX group and 1347 of 3834 (35.1%) for the SC-BPN group, a 6.7% difference (95% CI, -0.1% to 13.6%; P < .001). The CDF for the SC-BPN group (26.7%) was statistically superior to the CDF for the SL-BPN/NX group (0; P = .004). Injection site adverse events (none severe) occurred in 48 participants (22.3%) in the SL-BPN/NX group and 40 (18.8%) in the SC-BPN group. Conclusions and Relevance:Compared with SL buprenorphine, depot buprenorphine did not result in an inferior likelihood of being a responder or having urine test results negative for opioids and produced superior results on the CDF of no illicit opioid use. These data suggest that depot buprenorphine is efficacious and may have advantages. Trial Registration:ClinicalTrials.gov Identifier: NCT02651584.

Project description:ImportanceIn 2017, the US Food and Drug Administration (FDA) approved a monthly injectable form of buprenorphine, extended-release buprenorphine; published data show that extended-release buprenorphine is effective compared with no treatment, but its current cost is higher and current retention is lower than that of transmucosal buprenorphine. Preliminary research suggests that extended-release buprenorphine may be an important addition to treatment options, but the cost-effectiveness of extended-release buprenorphine compared with transmucosal buprenorphine remains unclear.ObjectiveTo evaluate the cost-effectiveness of extended-release buprenorphine compared with transmucosal buprenorphine.Design, setting, and participantsThis economic evaluation used a state transition model starting in 2019 to simulate the lifetime of a closed cohort of individuals with OUD presenting for evaluation for opioid agonist treatment with buprenorphine. The data sources used to estimate model parameters included cohort studies, clinical trials, and administrative data. The model relied on pharmaceutical costs from the Federal Supply Schedule and health care utilization costs from published studies. Data were analyzed from September 2021 to January 2023.InterventionsNo treatment, treatment with transmucosal buprenorphine, or treatment with extended-release buprenorphine.Main outcomes and measuresMean lifetime costs per person, discounted quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs).ResultsThe simulated cohort included 100 000 patients with OUD receiving (61% male; mean [SD] age, 38 [11] years) or not receiving medication treatment (58% male, mean [SD] age, 48 [18] years). Compared with no medication treatment, treatment with transmucosal buprenorphine yielded an ICER of $19 740 per QALY. Compared with treatment with transmucosal buprenorphine, treatment with extended-release buprenorphine yielded lower effectiveness by 0.03 QALYs per person at higher cost, suggesting that treatment with extended-release buprenorphine was dominated and not preferred. In probabilistic sensitivity analyses, treatment with transmucosal buprenorphine was the preferred strategy 60% of the time. Treatment with extended-release buprenorphine was cost-effective compared with treatment with transmucosal buprenorphine at a $100 000 per QALY willingness-to-pay threshold only after substantial changes in key parameters.Conclusions and relevanceIn this economic evaluation of extended-release buprenorphine compared with transmucosal buprenorphine for the treatment of OUD, extended-release buprenorphine was not associated with efficient allocation of limited resources when transmucosal buprenorphine was available. Future initiatives should aim to improve retention rates or decrease costs associated with extended-release buprenorphine.

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Buprenorphine treatment formulations: Preferences among persons in opioid withdrawal management.

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Buprenorphine treatment formulations: Preferences among persons in opioid withdrawal management.

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