PROTOCOL NIDA-CTN-0068


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

Principal Investigator
Madhukar Trivedi, MD
University of Texas Southwestern Medical Center
Madhukar.Trivedi@utsouthwestern.edu

Co-Lead Investigator & Project Director
Robrina Walker, PhD
University of Texas Southwestern Medical Center
Robrina.Walker@utsouthwestern.edu

The primary objective of this double-blind, placebo-controlled, adaptive, randomized clinical trial is to evaluate the efficacy of extended-release naltrexone plus bupropion as a combination pharmacotherapy for methamphetamine use disorder. Secondary outcomes will assess the safety of naltrexone plus bupropion and determine the efficacy of the combination pharmacotherapy on other substance use outcomes, on depression symptom scores, and on quality of life ratings. 370 individuals with moderate or severe methamphetamine use disorder will be randomly assigned to the active medication combination arm or the matching placebo arm. Participants will have visits twice weekly during the 12 week medication phase and complete follow-up visits in weeks 13 and 16.

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Supported by a grant from the National Institute on Drug Abuse to the University of Washington Alcohol and Drug Abuse Institute.
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Updated 1/2017 -- http://ctndisseminationlibrary.org/protocols/ctn0068.htm
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