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Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder
Sponsor: University of Texas Southwestern Medical Center
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.
Official title: NIDA (National Institute on Drug Abuse) CTN (Clinical Trials Network) Protocol 0068: Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
403
Start Date
2017-05-05
Completion Date
2019-07-25
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
Naltrexone: Vivitrol®
Naltrexone: 380 mg vial, 4 intramuscular injections administered every 3 weeks
Placebo (PLB) Injectable
Placebo: 4 intramuscular injections administered every 3 weeks
Bupropion: Wellbutrin XL®
Bupropion: 450 mg oral dose daily
Placebo (PLB) Oral
Placebo: once-daily oral placebo tablets
Locations (8)
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