Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder
Completed · Phase 3 · Has a placebo group
Conditions studied: Methamphetamine Use Disorder
In brief
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.
Key facts
- Study ID
- NCT03078075
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 403
- Starts
- 2017-05-05
- Expected to finish
- 2019-07-25
- Last updated by the study team
- 2021-05-03
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of California Los Angeles (UCLA) Center for Behavioral Addiction Medicine (CBAM) — Los Angeles, California, United States
- Substance Use Research Unit (SURU) at the San Francisco Dept. of Public Health — San Francisco, California, United States
- Hennepin County Medical Center- Berman Center for Research — Minneapolis, Minnesota, United States
- New York State Psychiatric Institute (NYSPI)- Substance Use Research Center (SURC) — New York, New York, United States
- CODA, Inc. — Portland, Oregon, United States
- Behavioral Health Services (BHS) of Pickens County — Pickens, South Carolina, United States
- University of Texas Southwestern Medical Center — Dallas, Texas, United States
- University of Texas Health Science Center - Center for Neurobehavioral Research on Addiction (CNRA) — Houston, Texas, United States
Full record on ClinicalTrials.gov
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