1. Participants receiving weekly and monthly subcutaneous buprenorphine depot formulations reported improved treatment satisfaction compared with those receiving sublingual buprenorphine in opioid dependence.
2. These findings suggest that treatment satisfaction and other patient-reported outcomes may serve as alternative end points to traditional markers of substance use in addiction management outcome studies.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Opioid dependence is a chronic relapsing disorder with considerable individual and public health burden. The current standard of care includes treatment with sublingual (SL) buprenorphine combined with psychosocial and behavioral support. However, SL formulations of buprenorphine are prone to nonmedical use, prompting models of care requiring frequent clinical monitoring. Long-acting injectable formulations have been developed to mitigate some of these concerns including a weekly and monthly formulation with flexible doses that has shown noninferiority and superiority to SL buprenorphine. This randomized controlled trial, DEBUT, sought to compare patient satisfaction between depot buprenorphine and daily SL buprenorphine in adult outpatients with opioid dependence. Participants were randomized for treatment over 24 weeks at 6 outpatient sites in Australia from October 2018 to September 2019. The primary outcome was the difference in global treatment satisfaction, assessed via the Treatment Satisfaction Questionnaire for Medication (TSQM) at week 24. Secondary objectives included other patient-reported outcomes such as quality of life, treatment burden, and health-related outcomes. In total, 119 participants were randomized to receive either SC depot buprenorphine (60 participants, 50.4%) or SL buprenorphine (59 participants, 49.6%). At 24 weeks, the mean TSQM global satisfaction score was significantly higher in the depot cohort compared to the SL cohort (82.5 vs 74.3; where higher scores indicate greater satisfaction). Improved outcomes were also observed for several secondary objectives in the depot cohort including treatment burden assessed via the Treatment Burden Questionnaire (TBQ) global score (13.2 vs 28.6; where lower scores indicate lower burden). No participants withdrew from the trial medication or the trial due to adverse events. A limitation of this study was that the sample size enrolled made it difficult to draw conclusions on the clinical relevance of the PROs, based on the number of participants enrolled and the length of the study.
In-Depth [randomized controlled trial]: This open-label, randomized parallel group-active-controlled trial was conducted among adult patients with opioid dependence at 6 outpatient sites in Australia from October 2018 to September 2019. Upon screening 131 participants with opioid dependence eligible for the study, 119 participants (70 [58.8%] men; mean [SD] age, 44.4 [10.5] years) were enrolled, randomized to, and received either depot buprenorphine (60 participants [50.4%]) or SL buprenorphine (59 participants [49.6%]). One participant (0.8%) who had been randomized to the SL buprenorphine group withdrew consent and did not receive study treatment. Prior to enrollment in the study, all participants were receiving SL buprenorphine for management. For the primary outcome, the mean TSQM global satisfaction score was significantly higher for the depot cohort compared to the SL cohort at week 24 (mean [SE] score, 82.5 [2.3] vs 74.3 [2.3]; difference, 8.2; 95%CI, 1.7 to 14.6; P = 0.01). Furthermore, improved outcomes were observed for several secondary outcomes after treatment with depot buprenorphine including treatment burden assessed via the TBQ global score, where a lower score indicates lower burden (mean [SE] score, 13.2 [2.6] vs 28.6 [2.5]; difference, −15.4; 95%CI, −22.6 to −8.2; P < 0.001). Lastly, 39 participants (65.0%) in the depot buprenorphine cohort experienced a total of 117 adverse drug reactions, mainly injection site reactions of mild intensity following SC administration, compared to 12 participants (20.3%) in the SL buprenorphine group with 21 total adverse drug reactions. No participants withdrew from the trial medication or the trial due to these adverse events.
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