Depot buprenorphine administered with subcutaneous (SC) injections led to improved treatment satisfaction compared with daily sublingual (SL) buprenorphine, according to a randomized clinical trial of adult patients with opioid dependence.
The researchers conducted the Depot Evaluation-Buprenorphine Utilization Trial (DEBUT) (Identifier: ANZCTR12618001759280) at 6 outpatient drug treatment centers in Australia.
The study included 119 participants (70 men; mean age=44.4 years), who were randomly assigned to receive either depot buprenorphine (n=60) or SL buprenorphine (n=59). A total of 54 participants in the depot buprenorphine group and 27 participants in the SL buprenorphine group attended all 7 assessment visits.
A total of 76 participants had primarily used heroin, not prescription opioids.
The mean daily dose of SL buprenorphine administered was 15.6 mg/d. A total of 29 participants in the depot buprenorphine group received at least 1 dose per week (mean of 21.5 mg/week, 107.4 mg/month).
The mean Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score at baseline was 71.2 (standard deviation (SD): 18.0) in the depot buprenorphine group and 73.8 (SD: 17.5) in the SL buprenorphine group. The mean score at week 24 was 82.5 for the depot buprenorphine group and 74.3 for the SL buprenorphine group (95% CI, 1.7-14.6; P =.01).
The corresponding mean scores for the overall study period were 82.4 for the depot buprenorphine group and 73.8 for the SL buprenorphine group (difference, 8.6; 95% CI, 3.3-13.9; P =.002). The analysis population for the primary outcome was 59 (98.3%) in the depot buprenorphine group and 57 (96.6%) in the SL buprenorphine group.
The study researchers identified a significant improvement in TSQM convenience score at 4 weeks after initiation of study treatment, and that difference lasted until week 24 while treatment effectiveness score increased steadily from baseline until week 24. They found that the number of participants with a TSQM global satisfaction score of 80 or greater was higher in the depot buprenorphine group (32 participants [53.3%]) than in the SL buprenorphine group (20 participants [33.9%]) at week 24. The numbers needed to treat (NNT) to achieve the threshold of 80 or greater was 5.1 (95% CI, 2.8-61.1).
Adverse drug reactions (ADR) and treatment-emergent adverse events (TEAEs) were higher among the depot buprenorphine group (39 participants experienced 117 ADR) than in the sublingual buprenorphine group (12 participants experienced 21 ADR) while the same number of serious adverse events (SAE) occurred in each group (n=9).
The incidence of all TEAEs reported during the trial was higher in the depot buprenorphine group (54 participants [90.0%]) than the SL buprenorphine group (49 participants [83.1%]), mainly related to injection site reactions of generally mild intensity in the depot buprenorphine group.
Limitations of the study included the fact that it was conducted under naturalistic conditions in Australia and some findings, such as treatment convenience and burden, may be “less straightforward in countries and regions with different frequency and grade of supervision during dispensing of medication, such as France and the United States,” the study authors said.
Disclosure: This research was supported by Camurus AB. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies, including Camurus.
Please see the original reference for a full list of disclosures.
Lintzeris N, Dunlop AJ, Haber PS, et al. Patient-reported outcomes of treatment of opioid dependence with weekly and monthly subcutaneous depot vs daily sublingual buprenorphine: a randomized clinical trial. JAMA Network Open. Published online May 10, 2021. doi: 10.1001/jamanetworkopen.2021.9041