Randomized, Placebo-Controlled, Multi-Site Trial of Extended-Release Naltrexone Injection/Bupropion XL Tablets in the Treatment of Methamphetamine Use Disorder
National Institute on Drug Abuse (NIDA)
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.
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 "respo…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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 bi…
Interventions
- Drugextended-release naltrexone (XR-NTX)
Once per three weeks injections of extended-release naltrexone
- Drugextended release bupropion (BUP-XL) tablets (BUP-XL)
Daily oral extended release bupropion tablets
- DrugiPLB
Once per three weeks injections of placebo
- DrugoPLB
Daily oral placebo tablets
Locations (11)
- University of Arkansas for Medical SciencesLittle Rock, Arkansas
- University of California Los AngelesLos Angeles, California
- University of California at San DiegoSan Diego, California
- Indiana UniversityIndianapolis, Indiana
- University of Kansas Medical CenterKansas City, Kansas
- University of MinnesotaMinneapolis, Minnesota