NCT06233799

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

Randomized, Placebo-Controlled, Multi-Site Trial of Extended-Release Naltrexone Injection/Bupropion XL Tablets in the Treatment of Methamphetamine Use Disorder

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 "responders," defined as participants who provide at least 3 MA-negative urine drug screens (UDS) out of 4 samples obtained during the evaluation period (i.e., Weeks 11-12) of the 12-week long treatment phase, relative to the iPLB/oPLB arm. Secondary objectives include evaluating the effect of the extended release naltrexone plus bupropion XL (XR-NTX/BUP-XL) arm compared to the iPLB/oPLB arm on safety, other substance use outcomes, depression scores, quality of life, overall functioning, clinic attendance, and medication adherence.

Conditions

• Methamphetamine-dependence
• Methamphetamine Abuse

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-10-30
• Completion: 2027-04-30
• First posted: 2024-01-31
• Last updated: 2026-02-19

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study