Efficacy and Safety of 24 Weeks Sustained-release Dexamphetamine in Patients With Moderate to Severe Cocaine Use Disorder With Comorbid Opioid Use Disorder - A Multicenter Randomized, Double-blind, Placebo-controlled Study

What this Trial Is About

Researchers are evaluating sustained-release dexamphetamine as a potential treatment for people with moderate to severe cocaine use disorder who are also receiving methadone maintenance treatment for opioid use disorder. This study aims to determine whether this medication can reduce cocaine use and improve overall health and quality of life in this population, addressing the current lack of approved medications for cocaine addiction. Participants will be randomly assigned to receive either sustained-release dexamphetamine tablets or a placebo for 24 weeks. The dexamphetamine dose will be gradually increased to a target of 90 mg per day if tolerated, taken daily in the morning. Medication is dispensed twice weekly under supervision. After the initial 24-week treatment phase, there is a 6-week double-blind phase to assess the effects of continuing versus discontinuing dexamphetamine. During the study, participants will visit the treatment center twice weekly to take medication under supervision and provide urine samples to measure cocaine abstinence. Researchers will assess cocaine use through self-report and urinalysis, monitor health status including physical, mental, and social functioning, and track medication adherence and safety. The primary outcome is the number of days abstinent from cocaine in the final four weeks of treatment. The total study duration is approximately 30 weeks including both treatment phases.

Efficacy and Safety of Sustained-release Dexamphetamine in Patients With Moderate to Severe Cocaine Use Disorder