CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 403 enrolled
Drug / intervention
Naltrexone: Vivitrol® +3 moredrug
Likely dose
Naltrexone: Vivitrol® 380 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03078075
NCT03078075Phase 3Completed
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NIDA (National Institute on Drug Abuse) CTN (Clinical Trials Network) Protocol 0068: Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder

University of Texas Southwestern Medical Center·interventional·Posted Mar 13, 2017·Updated May 3, 2021

In Brief

A Phase 3 clinical trial evaluating Naltrexone: Vivitrol®, Placebo (PLB) Injectable, and 2 other interventions for Methamphetamine Use Disorder. Completed, enrolled 403 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMethamphetamine Use Disorder
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA), The Emmes Company, LLC

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 13, 2017
Enrollment StartMay 5, 2017
Primary CompletionJul 3, 2019
Study CompletionJul 25, 2019
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 9.3 years ago

Interventions

Naltrexone: Vivitrol®drug

Naltrexone: 380 mg vial, 4 intramuscular injections administered every 3 weeks

Placebo (PLB) Injectabledrug

Placebo: 4 intramuscular injections administered every 3 weeks

Bupropion: Wellbutrin XL®drug

Bupropion: 450 mg oral dose daily

Placebo (PLB) Oraldrug

Placebo: once-daily oral placebo tablets