Testing Long-Term High-Dose Lisdexamfetamine with Usual Care for Adults with Moderate to Severe Methamphetamine Use Disorder

What this Trial Is About

Methamphetamine use disorder MUD is a growing public health concern. Researchers are evaluating the long-term use of high-dose stimulant agonist therapy with Lisdexamfetamine LDX-01 alongside standard treatment in people with moderate to severe MUD. This phase 2 trial aims to assess the feasibility of this approach, focusing on treatment retention, adherence, and satisfaction compared to a placebo group. Participants will be randomly assigned to one of two groups standard treatment plus high-dose LDX-01 or standard treatment plus a matched placebo. The medication is given once daily for 25 weeks in three phases induction with increasing doses during the first week, maintenance with a target dose from weeks 2 to 21, and tapering doses from weeks 22 to 25. Treatment is provided at a clinical site with weekly visits. During the 30-week participation, participants will attend weekly clinic visits for medication and assessments. Urine samples will be collected every two weeks from weeks 1 to 25, and again at weeks 26 and 30. Questionnaires will also be completed during visits. The main outcomes measured include retention in treatment and study, treatment satisfaction, and adherence throughout the study period.

Feasibility of Long-term, High-dose Stimulant for Methamphetamine Use Disorder