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

NCT06233799 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2026-05-14

No results posted yet for this study

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.

Conditions

  • Methamphetamine-dependence
  • Methamphetamine Abuse

Interventions

DRUG

extended-release naltrexone (XR-NTX)

Once per three weeks injections of extended-release naltrexone

DRUG

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

Daily oral extended release bupropion tablets

DRUG

iPLB

Once per three weeks injections of placebo

DRUG

oPLB

Daily oral placebo tablets

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    lead NIH

Principal Investigators

  • Raul Mandler, MD · NIDA/NIH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2026-10-30
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06233799 on ClinicalTrials.gov