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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
National Institute on Drug Abuse (NIDA)
Study ID
NCT06233799
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Methamphetamine Abuse
  • Methamphetamine-dependence

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • extended-release naltrexone (XR-NTX) — DRUG
    Once per three weeks injections of extended-release naltrexone
  • extended release bupropion (BUP-XL) tablets (BUP-XL) — DRUG
    Daily oral extended release bupropion tablets
  • iPLB — DRUG
    Once per three weeks injections of placebo
  • oPLB — DRUG
    Daily oral placebo tablets

Study Details

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.

Key Dates

Start date
Jul 1, 2024
Status verified
Feb 2026
Primary completion
Oct 30, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: XR-NTX/BUP-XL
    Participants randomized to the (XR-NTX/BUP-XL) arm will receive 450 mg of once-daily oral extended-release bupropion tablets and once every three weeks (Weeks 1, 4, 7, and 10) injections of extended-release naltrexone (Vivitrol®)
  • Placebo Comparator: PLB/PLB
    Participants randomized to the PLB arm will receive once-daily placebo tablets and once every three weeks (Weeks 1, 4, 7, and 10) placebo injections.

Primary Outcome Measure

Number of Participants with at least 75% methamphetamine-negative urine drug screen tests during the evaluation period (i. e., Weeks 11-12) [ Time Frame: 2 weeks (i. e., Weeks 11-12) ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
University of Arkansas for Medical SciencesLittle RockArkansas72205
Alison Oliveto, PhD
University of California Los AngelesLos AngelesCalifornia90038
Jesse Clark, MD
University of California at San DiegoSan DiegoCalifornia92037
Cassandra Henrickson, MAS
[email protected]
Indiana UniversityIndianapolisIndiana46202
Leslie Hulvershorn, MD
Olawale Ojo, MD
University of Kansas Medical CenterKansas CityKansas66160
Valerie Davis
[email protected]
913-588-6440
University of MinnesotaMinneapolisMinnesota55415
Gavin Bart, MDPhD
CODAPortlandOregon97214-
MUSC/BHSPickensSouth Carolina29671-
University of TennesseeMemphisTennessee38119
Ronald Cowan, MDPhD
University of Texas Southwestern Medical CenterDallasTexas75247
Manish Jha, MD
University of VirginiaCharlottesvilleVirginia22903
Nassima Ait-Daoud Tiouririne, MD

Find similar trials in Little Rock, AR

By research site
University of Arkansas for Medical Sciences· Little Rock, ARUniversity of California Los Angeles· Los Angeles, CAUniversity of California at San Diego· San Diego, CAIndiana University· Indianapolis, INUniversity of Kansas Medical Center· Kansas City, KSUniversity of Minnesota· Minneapolis, MN

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