NCT05283304

Monthly Injectable BUP for MA Use Disorder (MURB) Trial

Randomized, Double-blind, Placebo-controlled Trial of Monthly Injectable Buprenorphine (BUP) for Methamphetamine (MA) Use Disorder

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Madhukar H. Trivedi, MD · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is a 12-week randomized, double-blind, placebo-controlled trial that will investigate the use of injectable buprenorphine (BUP-Inj) compared to injectable placebo (PBO-Inj) for the treatment of methamphetamine use disorder (MUD) among individuals with mild co-use of opioids.

Detailed description

Primary Objective: To evaluate whether assignment to 12 weeks of outpatient BUP-Inj compared to 12 weeks of outpatient PBO-Inj reduces MA use (as measured by twice-weekly urine drug screens (UDS)) during Weeks 9-12 in participants with moderate to severe MUD with co-occurring mild opioid use disorder (OUD) or opioid misuse not warranting medication for opioid use disorder (MOUD). Secondary Objectives: To evaluate whether assignment to 12 weeks of outpatient BUP-Inj compared to 12 weeks of outpatient PBO-Inj among participants with moderate to severe MUD with co-occurring mild OUD or opioid misuse not warranting MOUD improves: 1) outcomes related to alternate measures of MA use including total number of MA negative urine drug screens (UDS) during study and self-reported days of MA use; 2) measures of opioid use and self-reported frequency of opioid use; and 3) measures of MA and opioid co-use and self-reported days of MA and opioid co-use.

Conditions

• Methamphetamine-dependence

Interventions

Type	Name	Description
DRUG	Buprenorphine injection (BUP-Inj)	Sublingual Buprenorphine induction, then SublocadeTM, Indivior injectable (300mg)
OTHER	Placebo injection	Sublingual buprenorphine induction, then Placebo injectable (300 mg)

Timeline

• Start date: 2023-03-24
• Primary completion: 2023-10-20
• Completion: 2023-11-19
• First posted: 2022-03-16
• Last updated: 2025-03-21
• Results posted: 2025-03-21

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study