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A new study compares patients self-reported outcomes after depot or daily sublingual buprenorphine treatment, including satisfaction and burden rates.
Patient-reported outcomes (PRO) in the treatment of opioid dependence may be affected by the method of treatment.
Investigators, led by Fredrik Tiberg, PhD, of Camurus, found that patients in treatment receiving depot buprenorphine self-reported an improved treatment satisfaction compared to those receiving daily sublingual (SL) buprenorphine.
According to investigators, there is an increased interest in using PRO as an alternative end point for assessment and comparison of different medication in addiction outcome studies.
The team compared depot buprenorphine versus daily SL buprenorphine, using the primary end point Treatment Satisfaction Questionnaire for Medication (TSQM).
As a result, the Depot Evaluation-Buprenorphine Utilization Trial (DEBUT) was an open-label, parallel group randomized clinical trial.
It was conducted in 6 outpatient drug treatment centers in Australia from October 2018 to September 2019.
Participants included patients aged ≥18 years who met criteria for opioid dependence. Excluded patients included those with severe respiratory and hepatic insufficiency and pregnancy.
Investigators used the primary efficacy outcome measure in global treatment satisfaction in the TQSM, with a range of 0 – 100, with higher scores showing greater satisfaction.
It was comprised of 14 items across 4 categories, including effectiveness, side effects, convenience, and global satisfaction. Each item was scored on a 5- or 7-point Likert scale, except for side effects (yes or no).
The secondary outcomes included other patient reported outcomes including satisfaction ratings (0 – 100), Patient Global Impression of Improvement (1 – 7, lower score indicating more improvement) and Treatment Burden Questionnaire (TBQ; 1 – 150, lower score indicating lower burden).
Other secondary outcomes included measures of opioid use, retention in treatment, and safety, including treatment-emergent adverse events (TEAEs), adverse drug reactions (ADRs), and serious AEs (SAEs).
During the treatment period, 131 patients with opioid dependence were screened for eligibility, with 119 patients enrolled in the study. The patients included 70 (58.8%) men with a mean age of 44.4 years. Patients were receiving SL buprenorphine treatment prior to the study start.
After randomization, 60 participants (50.4%) received depot buprenorphine and 59 participants received SL buprenorphine (49.6%). A participant in the SL buprenorphine group withdrew consent and did not participate in the study.
Investigators found the mean duration since diagnosis of opioid dependence before randomization was 13.0 years and the mean duration from the first illicit use of opioids to randomization was 19.3 years.
Data show the mean daily dose of SL buprenorphine was 15.6 mg/d and the mean weekly depot buprenorphine dose was 21.5 mg/week and mean monthly dose was 107.4mg/month.
The team found the primary outcome TSQM Satisfaction Score had a mean at baseline of 71.2 in the depot buprenorphine group and 73.8 in the SL buprenorphine group.
At week 24 in the mixed model for repeated measure (MMRM), investigators found the mean TSQM satisfaction score was significantly higher for the depot treatment group versus the sublingual group.
The mean score for depot buprenorphine was 82.5 versus a mean score of 74.3 in the SL buprenorphine group, with a difference of 8.2 (95% CI, 1.7 – 14.6; P = .01).
The overall study period had a mean score of 82.4 for the depot buprenorphine group and 73.8 for the SL buprenorphine group, with a difference of 8.6 (95% CI, 3.3 – 13.9; P = .002).
The team also noted improved results in the secondary outcomes after depot buprenorphine treatment. The treatment burden in the TBQ global score was (13.2 vs 28.6; 95% CI, −22.6 to −8.2; P <.001).
Data show 39 participants (65%) in the depot buprenorphine group experienced 117 adverse drug reactions, with most involving mild injection site reactions. In the sublingual buprenorphine group, the team saw 21 adverse drug reactions.
However, no participants in the trial withdrew due to adverse effects.
Investigators concluded that the study showed higher satisfaction in treatment with depot buprenorphine than SL buprenorphine, as well as improvement in treatment convenience, effectiveness, patient satisfaction, and treatment burden.
“In this study, participants randomized to receive depot buprenorphine administered weekly or monthly reported significantly higher and more sustained treatment global satisfaction than those randomized to continue to receive SL buprenorphine, adding to the evidence regarding depot buprenorphine from earlier double-blind RCTs,” investigators wrote.
The study, “Patient-Reported Outcomes of Treatment of Opioid Dependence With Weekly and Monthly Subcutaneous Depot vs Daily Sublingual Buprenorphine,” was published online in JAMA Network Open.