Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder

• Status: Completed
• Trial end date: 2019-07-25
• Target enrollment: 0
• Participant gender: All

Summary

This is a double-blind, placebo-controlled, randomized clinical trial evaluating the efficacy of extended-release naltrexone plus bupropion as a combination pharmacotherapy for methamphetamine use disorder. Participants will be randomly assigned to the active medication combination (AMC) group or matching placebo group and will receive medications over the course of 12 weeks. Follow-ups will occur in weeks 13 and 16.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborators: National Institute on Drug Abuse (NIDA); The Emmes Company, LLC; The EMMES Corporation
• Treatments: Bupropion; Methamphetamine; Naltrexone

Criteria

Inclusion Criteria:

• 18 to 65 years old;

• Interested in reducing/stopping methamphetamine use;

• Speak English;

• Agree to use acceptable birth control (if applicable);

• Be opioid-free at randomization;

• Willing to comply with all study procedures and medication instructions;

• Agree to use a cell phone (or similar study device) to take videos of medication dosing.

Exclusion Criteria:

• Medical or psychiatric condition which would make participation unsafe;

• Recently participated in a study of pharmacological or behavioral treatment for methamphetamine use disorder;

• Recently taken an investigational drug;

• Prescribed and taken naltrexone or bupropion ≤ 30 days from consent;

• Current or planned extended absence during study period (e.g., jail, surgery, pending legal action);

• Currently pregnant or breastfeeding.