Actively Recruiting
Randomized Trial of Extended-Release Naltrexone Injection and Bupropion XL Tablets for Methamphetamine Use Disorder
Led by National Institute on Drug Abuse (NIDA) · Updated on 2026-06-04
360
Participants Needed
11
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of extended-release naltrexone combined with bupropion XL (XR-NTX/BUP-XL) compared to placebo injections and oral placebo tablets in reducing methamphetamine use in people with moderate or severe methamphetamine use disorder (MUD). This randomized, double-blind, placebo-controlled clinical trial involves 360 participants who want to stop or reduce their methamphetamine use. The study aims to see if XR-NTX/BUP-XL can increase the number of participants who have mostly negative methamphetamine urine tests during the last two weeks of treatment. Participants are randomly assigned to one of two groups: one group receives injections of extended-release naltrexone every three weeks along with daily oral extended-release bupropion tablets for 12 weeks. The other group receives matching placebo injections and daily placebo tablets on the same schedule. The treatment phase lasts 12 weeks, with injections given at Weeks 1, 4, 7, and 10, and daily pills taken throughout. During the study, participants will provide urine samples to test for methamphetamine use, and researchers will monitor safety by tracking adverse events. Other assessments include measuring cravings, depression symptoms, quality of life, treatment effectiveness, and medication adherence. Participants will use a smartphone app to record daily medication dosing. The main outcome is the number of participants with at least 75% methamphetamine-negative urine tests during Weeks 11 and 12. The study continues through follow-up visits to evaluate these measures over a total period of 16 weeks.
CONDITIONS
Brief Title
Trial of Naltrexone/Bupropion for the Treatment of Methamphetamine Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Is 18 to 65 years of age
- Meets DSM-5 criteria for moderate or severe methamphetamine use disorder (4 or more criteria)
- Interested in reducing or stopping methamphetamine use
- Able to speak English and provide written informed consent
- Self-reports methamphetamine use on 18 or more days in the 30 days before consent
- Provides at least 2 positive urine samples for methamphetamine out of 3 tests within 10 days
- If female at birth or has a uterus, is not pregnant, agrees to use birth control, and will have pregnancy tests unless hysterectomy documented
- Not physically dependent on opioids and confirmed opioid-free before naltrexone injection
- Willing to comply with study procedures and medication instructions
- Agrees to use a smartphone app to record daily medication dosing
You will not qualify if you...
- Has an acute medical or psychiatric disorder making participation difficult or unsafe
- Has suicidal or homicidal thoughts needing immediate attention
- History of epilepsy, seizure disorder, head trauma with neurological effects, current anorexia or bulimia, or other seizure risk conditions
- Has heart problems like second or third degree heart block, atrial fibrillation, prolonged QTc, or other ECG findings that preclude safe participation
- Stage 2 hypertension (≥160/100 in 2 of 3 readings during screening)
- Elevated bilirubin or liver function tests more than 5 times normal
- Low platelet count (<100,000/microliter)
- Body condition preventing intramuscular injection of extended-release naltrexone
- Known allergy to study drug components
- Participation in MUD treatment study within 6 months
- Use of investigational drug within 30 days
- Use of naltrexone or bupropion within 30 days
- Enrolled in formal substance use disorder treatment
- Taking medications that could interact adversely with study drugs
- Current use of alcohol, benzodiazepines, or sedative hypnotics that preclude safe participation
- Need for opioid medications during study
- Planned surgery during study
- Currently in jail, prison, inpatient facility, or with unstable living arrangements
- If female at birth or has a uterus, currently pregnant, breastfeeding, or planning conception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive either extended-release naltrexone injections every three weeks plus daily oral extended release bupropion tablets, or matching placebo injections and tablets, for methamphetamine use disorder.
Visits every three weeks for injections and daily oral medication administration
Duration - 4 weeks
Participants are monitored for safety, craving severity, depression, treatment effectiveness, and quality of life after completing the treatment phase.
Periodic visits during 4-week follow-up after treatment
Trial Site Locations
Total: 11 locations
1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
2
University of California Los Angeles
Los Angeles, California, United States, 90038
Actively Recruiting
3
University of California at San Diego
San Diego, California, United States, 92037
Actively Recruiting
4
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
5
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
6
University of Minnesota
Minneapolis, Minnesota, United States, 55415
Actively Recruiting
7
CODA
Portland, Oregon, United States, 97214
Active, Not Recruiting
8
MUSC/BHS
Pickens, South Carolina, United States, 29671
Active, Not Recruiting
9
University of Tennessee
Memphis, Tennessee, United States, 38119
Actively Recruiting
10
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75247
Actively Recruiting
11
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
J
Jennifer Wong, PhD
J
Jana Drgonova, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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