Long-term safety of a weekly and monthly subcutaneous buprenorphine depot (CAM2038) in the treatment of adult out-patients with opioid use disorder.

ABSTRACT:

Aims

To assess the long-term safety of subcutaneous buprenorphine (CAM2038) weekly and monthly depots.

Design

Phase 3, open-label, observational, multi-centre 48-week trial (ClinicalTrials.gov NCT02672111).

Setting

Twenty-six out-patient sites (United States, United Kingdom, Hungary, Denmark, Sweden, Germany, Australia) between 14 December 2015 and 12 April 2017.

Participants

Two hundred and twenty-eight adults with opioid use disorder; 227 received CAM2038 (37 initiated onto CAM2038 and 190 converted from sublingual buprenorphine).

Interventions

CAM2038 weekly (8, 16, 24 or 32 mg) or monthly (64, 96, 128 or 160 mg) with flexible dosing and individualized titration utilizing multiple CAM2038 weekly and monthly doses.

Measurements

Safety variables,

SUBMITTER: Frost M 

PROVIDER: S-EPMC6771955 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature