Actively Recruiting
Trial of Naltrexone/Bupropion for the Treatment of Methamphetamine Use Disorder
Led by National Institute on Drug Abuse (NIDA) · Updated on 2026-05-14
360
Participants Needed
11
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trial of Naltrexone/Bupropion for the Treatment of Methamphetamine Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Meets DSM-5 criteria for moderate or severe methamphetamine use disorder
- 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 past 30 days
- Provides at least 2 positive methamphetamine urine samples out of up to 3 tests within 10 days
- If female with uterus, not pregnant, agrees to use birth control and have pregnancy tests unless hysterectomy documented
- Not physically dependent on opioids and opioid-free before naltrexone injection
- Willing to follow all 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 unsafe
- Has suicidal or homicidal thoughts needing immediate attention
- Has history of epilepsy, seizures, head trauma with neurological effects, current eating disorders, or other seizure risk conditions
- Has heart problems or abnormal ECG findings that prevent safe participation
- Has Stage 2 hypertension (≥160/100 in 2 of 3 readings)
- Has elevated liver function tests or bilirubin above limits
- Has low platelet count (<100,000/microliter)
- Has body size preventing safe injection of the study drug
- Allergic or sensitive to study medications or components
- Participated in pharmacological or behavioral treatment for methamphetamine use disorder in past 6 months
- Used investigational drugs in past 30 days
- Taken naltrexone or bupropion in past 30 days
- Currently enrolled in formal substance use disorder treatment
- Taking medications that may interact negatively with study drugs
- Has alcohol or sedative use that prevents safe participation
- Requires opioid medications during study
- Has planned surgery during study
- Is in jail, prison, inpatient facility, or has legal or unstable living situations preventing participation
- If female with uterus, is pregnant, breastfeeding, or planning conception
AI-Screening
AI-Powered Screening
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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
CONTACT
J
Jana Drgonova, PhD
CONTACT
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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