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Trial of Naltrexone/Bupropion for the Treatment of Methamphetamine Use Disorder | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Trial of Naltrexone/Bupropion for the Treatment of Methamphetamine Use Disorder

Randomized, Placebo-Controlled, Multi-Site Trial of Extended-Release Naltrexone Injection/Bupropion XL Tablets in the Treatment of Methamphetamine Use Disorder

NCT06233799•National Institute on Drug Abuse (NIDA)

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate the efficacy of extended release naltrexone plus bupropion XL (XR-NTX/BUP-XL) compared to matched injectable and oral placebo (iPLB/oPLB) in reducing methamphetamine (MA) use in individuals with moderate or severe methamphetamine use disorder (MUD) seeking to stop or reduce MA use.

Detailed Description

This is a double-blind, placebo-controlled, randomized clinical trial in which 360 individuals with moderate or severe MUD will be randomly assigned at a 1:1 ratio to receive either 1) extended release naltrexone (XR-NTX; as Vivitrol®) plus once daily oral extended release bupropion (BUP-XL) tablets (the XR-NTX/BUP-XL group) or 2) both the matching injection placebo (iPLB) and once daily oral placebo (oPLB) tablets (the iPLB/oPLB group). The study intervention consists of a 12-week treatment phase. It is hypothesized that the XR-NTX/BUP-XL arm will be associated with a greater number of "responders," defined as participants who provide at least 3 MA-negative urine drug screens (UDS) out of 4 samples obtained during the evaluation period (i.e., Weeks 11-12) of the 12-week long treatment phase, relative to the iPLB/oPLB arm. Secondary objectives include evaluating the effect of the extended release naltrexone plus bupropion XL (XR-NTX/BUP-XL) arm compared to the iPLB/oPLB arm on safety, other substance use outcomes, depression scores, quality of life, overall functioning, clinic attendance, and medication adherence.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Is 18 to 65 years of age;
•2. Meets DSM-5 criteria for moderate or severe MUD (4 or more criteria);
•3. Is interested in reducing or stopping MA use;
•4. Is able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study;
•5. Self-reports MA use on 18 or more days in the 30-day period prior to consent using the Timeline Followback (TLFB);
•6. Provides at least 2 urine samples positive for MA out of up to 3 tests, which will occur at least 2 days apart within a 10-day period;
•7. If assigned as female at birth and/or currently has a uterus, is not pregnant, agrees to use acceptable birth control methods, and have periodic urine pregnancy testing done during participation in the study unless documentation of hysterectomy provided;
•8. Is not physically dependent on opioids and meets subjective and objective measures of being opioid-free prior to naltrexone injection per study medical clinician's determination, including, if clinically required, a negative naloxone challenge;
•9. Is willing to comply with all study procedures and medication instructions;
•10. Agrees to use a smartphone app (downloaded for free to own device or on a study provided smartphone device) to take daily videos of medication dosing.

Exclusion Criteria

•1. Has an acute medical or psychiatric disorder that would, in the judgment of the study medical clinician, make participation difficult or unsafe;
•2. Has suicidal or homicidal ideation that requires immediate attention;
•3. Has a history of epilepsy, seizure disorder, or head trauma with neurological sequelae (e.g., loss of consciousness that required hospitalization); current anorexia nervosa or bulimia; or any other conditions that increase seizure risk in the opinion of the study medical clinician;
•4. Has evidence of second or third degree heart block, atrial fibrillation, atrial flutter, prolongation of the QTc, or any other finding on the screening ECG that, in the opinion of the study medical clinician, would preclude safe participation in the study;
•5. Has Stage 2 hypertension as determined by the study medical clinician (e.g., greater than or equal to 160/100 in 2 out of 3 readings during screening);
•6. Has any elevated bilirubin test value per laboratory criteria OR any other liver function test (LFT) value \> 5 times the upper limit of normal per laboratory criteria;
•7. Has a platelet count \<100 x 10exp3/microliter;
•8. Has a body habitus that precludes gluteal intramuscular injection of XR-NTX in accordance with the administration equipment (needle) and procedures;
•9. Has a known allergy or sensitivity to bupropion, naloxone, naltrexone, PLG (polyactideco-glycolide), carboxymethylcellulose or any other component of the XR-NTX diluents;
•10. Has been in a prior study of pharmacological or behavioral treatment for MUD within 6 months of study consent;
+9 more criteria

Locations (11)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

University of California Los Angeles

Los Angeles, California, United States

University of California at San Diego

San Diego, California, United States

Indiana University

Indianapolis, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

University of Minnesota

Minneapolis, Minnesota, United States

CODA

Portland, Oregon, United States

MUSC/BHS

Pickens, South Carolina, United States

University of Tennessee

Memphis, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Key Dates

Start Date

July 1, 2024

Primary Completion Date

October 30, 2026

Completion Date

April 30, 2027

Last Updated

February 19, 2026

Enrollment

360

ESTIMATED participants

Conditions

Methamphetamine-dependenceMethamphetamine Abuse

Interventions

extended-release naltrexone (XR-NTX)

DRUG

extended release bupropion (BUP-XL) tablets (BUP-XL)

DRUG

iPLB

DRUG

oPLB

DRUG

Contacts

Jennifer Wong, PhD

CONTACT

301-827-6267 Jennifer.Wong3@nih.gov

Jana Drgonova, PhD

CONTACT

301-827-5933 jana.drgonova@nih.gov

Screen, Treat and Retain Meth-using People With Opioid Use Disorders at Methadone Clinics

NCT04706624

Methamphetamine AbuseOpioid-use Disorder+1 more

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COMPLETEDNA

tACS Treatment for Cognitive Impairments in Methamphetamine Addicts

NCT06292156

Methamphetamine Abuse

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Trial of Naltrexone/Bupropion for the Treatment of Methamphetamine Use Disorder

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