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

This double-blinded, placebo-controlled study will investigate the effectiveness and safety of a combination pharmacotherapy for adults with moderate to severe methamphetamine use disorder. A total of 370 treatment-seeking participants will be randomized to either the 1) Active Medication Condition and receive injections of extended release naltrexone (Vivitrol®) plus 450 mg of once-daily oral extended-release bupropion tablets or the 2) matching placebo arm and receive injections of placebo plus once-daily oral placebo tablets. Injections will be administered every 3 weeks. During this 12-week medication phase, participants may be re-randomized to another arm, as determined by the a priori adaptive aspect of the study design; participants appearing to respond well to their originally-assigned arm will not be re-randomized. The primary goal of the study is to evaluate the effectiveness of the active medication condition compared to the placebo arm. After the medication phase, participants will complete a medication taper and post-medication phase follow-up visits during weeks 13 and 16.

RELATED STUDIES
RELATED RESOURCES

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Publications about CTN-0068

ClinicalTrials.gov (NCT03078075)

NIDA protocol page

 


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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 6/2017 -- http://ctndisseminationlibrary.org/protocols/ctn0068.htm
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