Addiction recovery among opioid-dependent patients treated with injectable subcutaneous depot buprenorphine: Interim analysis of a non-randomized prospective observational study (ARIDE)

Once-weekly or once-monthly injectable depot buprenorphine is approved for opioid agonist therapy (OAT) and provides clinically relevant plasma concentrations without daily peaks. The prolonged release of injectable depot buprenorphine might have beneficial implications on the patients’ quality of life and social participation.

The primary objective of this prospective non-interventional observational study is to evaluate the effects of subcutaneous injectable depot buprenorphine on the quality of life of patients in routine OAT care in Germany.

Secondary outcomes like illicit substance use, psychological distress, social participation and activity are assessed to provide an overall evaluation towards addiction recovery. The present study is a non-randomized prospective observational study with a control group (treatment-as-usual). To ensure comparability between both patient groups, suitable control patients from the same OAT unit will be matched pairwise to each patient treated with injectable depot buprenorphine. Matching variables are gender, duration of OAT, take-home prescription and psychosocial functioning.

Primary study endpoint is the difference of change in quality of life, assessed with the recently developed Opioid Substitution Treatment Quality of Life scale (OSTQOL), within the depot buprenorphine group between baseline and month 12.

The primary analysis will be carried out according to the intention-to-treat principle by comparing OSTQOL mean scores using dependent t-tests. For secondary analyses, group comparisons will be done by mixed model approaches with baseline OSTQOL score and the (pairwise) cluster term as covariates.

The study is running. At the conference results from at least 120 patients with study completion will be presented. ARIDE combines clinical OAT data with patient reported outcome data. The pairwise matching allows conclusions on effects of different OAT medications. The study findings will provide new insights in the addiction recovery processes of OAT patients treated with depot buprenorphine, also in times of Covid-19.