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

Walter Ling, Vijay R Nadipelli, Caitlyn T Solem, Naoko A Ronquest, Yu-Chen Yeh, Susan M Learned, Vishaal Mehra, Christian Heidbreder, Walter Ling, Vijay R Nadipelli, Caitlyn T Solem, Naoko A Ronquest, Yu-Chen Yeh, Susan M Learned, Vishaal Mehra, Christian Heidbreder

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 < 0.001; 300/100 mg: difference = 3.2, P = 0.002). Satisfaction was significantly higher for participants receiving BUP-XR 300/300 mg (88%, P < 0.001) and 300/100 mg (88%, P < 0.001) than placebo (46%). Employment and percentage of insured participants increased by 10.8% and 4.1% with BUP-XR 300/300 mg and 10.0% and 4.7% with 300/100 mg but decreased by 12.6% and 8.4% with placebo. Participants receiving BUP-XR compared with placebo had significantly fewer hospital days per person-year observed.

Conclusions: These 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.

Conflict of interest statement

The authors report no conflicts of interest

Figures

FIGURE 1
FIGURE 1
Percentage of subjects who were satisfied or dissatisfied with treatment at week 25a. BUP-XR, buprenorphine extended-release monthly injection, for subcutaneous use [CIII]; IDC, individual drug counselling; MSQ, Medication Satisfaction Questionnaire. aThe MSQ is a 7-point scale with the following ratings: 1, extremely dissatisfied, 2, very dissatisfied, 3, somewhat dissatisfied, 4, neither satisfied nor dissatisfied, 5, somewhat satisfied, 6, very satisfied, and 7, extremely satisfied. MSQ scores were categorized as satisfied (5–7), neutral (4), or dissatisfied (1–3).
FIGURE 2
FIGURE 2
Net change in percentage of participants employed (A) and with health insurance (B) at week 25. BUP-XR, buprenorphine extended-release monthly injection, for subcutaneous use [CIII]; IDC, individual drug counselling.

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Source: PubMed

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