Patient-centered Outcomes in Participants of a Buprenorphine Monthly Depot (BUP-XR) Double-blind, Placebo-controlled, Multicenter, Phase 3 Study.

ABSTRACT:

Objective

Opioid use disorder (OUD) is associated with physical, social, psychological, and economic burden. This analysis assessed the effects of RBP-6000, referred to as BUP-XR (extended-release buprenorphine), a subcutaneously injected, monthly buprenorphine treatment for OUD compared with placebo on patient-centered outcomes measuring meaningful life changes.

Methods

Patient-centered outcomes were collected in a 24-week, phase 3, placebo-controlled study assessing the efficacy, safety, and tolerability of BUP-XR 300/300?mg (6?×?300?mg) and 300/100?mg (2?×?300?mg followed by 4?×?100?mg) injections in treatment-seeking participants with moderate-to-severe OUD. Measures included the EQ-5D-5L, SF-36v2, Medication Satisfaction Questionnaire, employment/insurance status, and healthcare resource utilization (HCRU). Changes from baseline to end of study were compared across treatment arms, using mixed models for repeated measures.

Results

Participants receiving BUP-XR (n?=?389) versus placebo (n?=?98) had significantly greater changes from baseline on the EQ-5D-5L index (300/300?mg: difference?=?0.0636, P?=?0.003), EQ-5D-5L visual analog scale (300/300?mg: difference?=?5.9, P?=?0.017; 300/100?mg: difference?=?7.7, P?=?0.002), and SF-36v2 physical component summary score (300/300?mg: difference?=?3.8, P?ConclusionsThese results show the feasibility of measuring patient-centered life changes in substance use disorder clinical studies. Participants receiving up to 6 monthly injections of BUP-XR, compared with placebo, reported better health, increased medication satisfaction, increased employment, and decreased healthcare utilization.

SUBMITTER: Ling W 

PROVIDER: S-EPMC6844648 | biostudies-literature | 2019 Nov/Dec

REPOSITORIES: biostudies-literature