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

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Mar 10, 2017

Keywords

ClinConnect Summary

There will be 400 adults with moderate or severe methamphetamine use disorder randomized into this multi-site study. Eligibility will be determined during a maximum 21 day screening period. After screening is completed and eligibility is confirmed, including successful administration of a naloxone challenge, participants will begin the 12 week medication phase of the trial. Participants will be randomized to either the 1) AMC arm and receive injections of extended release naltrexone (XR-NTX; as Vivitrol®) plus once-daily oral extended-release bupropion tablets (BUP-XL) or the 2) matching pl...

Gender

ALL

Eligibility 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.