Addition of High Dose Stimulant and Engagement-focused Contingency Management to Treatment as Usual for Methamphetamine Use Disorder: Canadian Multi-centre Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating whether giving a high dose stimulant combined with Contingency Management helps adults who use methamphetamine reduce their days of use better than usual treatment. This multi-center, randomized, double-blind, placebo-controlled trial includes participants diagnosed with moderate to severe methamphetamine use disorder and aims to answer if the stimulant or the stimulant plus Contingency Management is more effective than placebo and usual care. Participants are randomly assigned to one of four groups: treatment as usual plus placebo, treatment as usual plus placebo with Contingency Management, treatment as usual plus high dose lisdexamfetamine, or treatment as usual plus high dose lisdexamfetamine with Contingency Management. The stimulant is taken orally once daily for 15 weeks with dosing starting lower and increasing in the first week, followed by a maintenance phase and then tapering. Contingency Management is provided for 12 weeks alongside the other treatments. During the 20-week trial, participants visit the clinic weekly for treatment and biweekly for study assessments lasting about an hour. At these visits, urine samples are collected and questionnaires completed to monitor methamphetamine use and other outcomes. Researchers will track medication adherence, safety events, quality of life changes, and treatment satisfaction. The main measure is the total number of days using methamphetamine during the 12-week maintenance phase.

Clinical Trial of High Dose Lisdexamfetamine and Contingency Management in MA Users