A pilot randomised controlled trial of brief versus twice weekly versus standard supervised consumption in patients on opiate maintenance treatment

Abstract

Introduction and aims: Methadone maintenance remains the mainstay of treatment for opiate dependence in Scotland. Guidelines recommend supervised self-administration for at least 3 months, yet this is often interpreted as long-term supervision. However, there is no evidence base for deciding the optimal period of supervision. We tested the feasibility of conducting a randomised controlled trial (RCT) of different supervision models.

Design and methods: Three armed pilot RCT, set in three Scottish treatment areas, recruited opiate-dependent patients who had received methadone treatment for 3 months. Participants were randomised to: (i) no supervision; (ii) twice weekly supervision; or (iii) daily supervision for further 3 months. As a pilot, key process measures were: recruitment rates, follow-up rates and treatment fidelity. We also wanted to estimate effect sizes of two co-primary outcomes for a full RCT: treatment retention and illicit heroin use. The recruitment target was 60 participants.

Results: One hundred and two eligible patients were identified, 60 (59%) participated, and 46 followed up (77%). Study fidelity was good with two participants moving group. Those randomised to no supervision were significantly happier with their group allocation. No significant differences were found in primary outcomes, although retention decreased with increased supervision, while illicit heroin use was least in those most supervised.

Discussion and conclusions: It is possible to recruit and randomise participants to an RCT comparing different forms of supervised consumption. Pilot data suggest increased supervision may reduce illicit heroin use, but may decrease retention. This should now be tested in a large-scale multicentre RCT.