Monthly Injectable BUP for MA Use Disorder (MURB) Trial

NCT05283304 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: NIDA CTN Protocol 0110
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Methamphetamine-dependence

Outcome Measures

Primary Outcomes (1)

• Number of Methamphetamine-negative Urine Samples

  Number of Methamphetamine (MA)-negative Urine Drug Screen (UDS) results obtained during Weeks 9 through 12 of the medication phase is measured for the BUP-Inj and PBO-Inj conditions. Number of UDS results / number of expected UDS results. Two UDS results were expected each week.

  weeks 9-12

Secondary Outcomes (6)

• Treatment Effective Score (TES) for MA-negative UDS Results

  weeks 1-12

• Number of Days of Methamphetamine Use During the Medication Phase

  weeks 1-12

• Treatment Effective Score (TES) for Opioid Negative UDS Results

  weeks 1-12

• Number of Days of Opioid Use During the Medication Phase

  weeks 1-12

• Treatment Effective Score (TES) for MA and Opioid Co-Use Compiled

  weeks 1-12

Study Arms (2)

Injectable Buprenorphine (BUP-inj)

EXPERIMENTAL

Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable buprenorphine (300 mg dose) every 4 weeks

Drug: Buprenorphine injection (BUP-Inj)

Injectable Placebo (PBO-inj)

PLACEBO COMPARATOR

Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable placebo (300 mg dose) every 4 weeks.

Other: Placebo injection

Interventions

Buprenorphine injection (BUP-Inj) DRUG

Sublingual Buprenorphine induction, then SublocadeTM, Indivior injectable (300mg)

Also known as: SublocadeTM, Indivior

Injectable Buprenorphine (BUP-inj)

Placebo injection OTHER

Sublingual buprenorphine induction, then Placebo injectable (300 mg)

Also known as: Placebo injection (PBO-Inj)

Injectable Placebo (PBO-inj)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study participants must:
• Be 18 to 65 years of age, inclusive;
• Able to understand and speak English or Spanish
• Be interested in reducing or stopping MA use;
• Meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for moderate or severe MUD (4 or more criteria);
• Self-report MA use on 18 or more days in the 30-day period prior to written consent using the TLFB;
• Provide at least 2 urine samples positive for MA out of a possible 3 tests to occur at clinic visits within a 10-day period with at least 2 days between visits;
• Meet DSM-5 criteria for mild OUD (at least 2 but no more than 3 criteria) prior to randomization OR opioid misuse demonstrated by self-report of opioid use of at least 2 days in the 30-day period prior to written consent using the TLFB;
• Provide a urine drug screen negative for opioids at least once during the screening period and on the day of expected randomization to indicate control over opioid use;
• Have a Clinical Opiate Withdrawal Scale (COWS) score of ≤8 at both a screening visit on which they provide a UDS negative for opioids and on the day of randomization.
• If female, agree to use acceptable methods of contraception and have periodic urine pregnancy testing during participation in the study unless unable to get pregnant;
• Be willing and able to provide consent and comply with all study procedures and medication instructions.

You may not qualify if:

• Study participants must not:
• Have suicidal or homicidal ideation that requires immediate attention;
• Have evidence of prolongation of the corrected QT interval (QTc) or any other finding on the screening ECG that, in the opinion of the Medical Clinician, would preclude safe participation in the study (e.g., hypokalemia, unstable atrial fibrillation) and be at significant risk for serious cardiac adverse events;
• Have a laboratory value with total bilirubin ≥1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) ≥3 × ULN, aspartate aminotransferase (AST) ≥5 × ULN, or serum creatinine \>2 × ULN;
• Have been in a study of pharmacological or behavioral treatment for addiction within 6 months prior to written study consent (smoking cessation excepted);
• Have taken an investigational drug in another study within 30 days prior to written study consent;
• Have been prescribed and taken buprenorphine or methadone within 30 days prior to written study consent;
• Be concurrently enrolled in formal behavioral or pharmacological addiction treatment services at the time of written consent;
• Be receiving ongoing treatment of medications that are clinically relevant Cytochrome P450 3A4 (CYP 3A4) or Cytochrome P4502C8 (CYP 2C8) inducers or inhibitors (e.g., rifampicin, azole antifungals, macrolide antibiotics), Class IA antiarrhythmic medications (e.g., quinidine, procainamide, disopyramide) or Class III antiarrhythmic medications (e.g., sotalol, amiodarone) at the time of randomization that, in the judgment of the Medical Clinician, could interact adversely with study medications or put them at significant risk for development of serotonin syndrome;
• Have a current pattern of alcohol, benzodiazepine, or other sedative hypnotic use which would preclude safe participation in the study as determined by the Medical Clinician;
• Have a surgery planned or scheduled, or other treatment that would require the use of opioid-containing medications (e.g., opioid analgesics) during the study period;
• Currently or soon to be in jail or prison; currently in any inpatient overnight facility as required by court of law or have pending legal action or other situation that could prevent participation in the study or in any study activities;
• If biologically female, be currently pregnant, breastfeeding, or planning on conception;
• Hypersensitivity (e.g., anaphylaxis) to buprenorphine or any component of the ATRIGEL formulation or their excipients;
• Have an abdominal area unsuitable for subcutaneous injections by the judgment of the Medical Clinician;

Sponsors & Collaborators

• Madhukar H. Trivedi, MD: lead

Study Sites (6)

UCLA Vine Street Clinic

Los Angeles, California, 90038, United States

Location

Highland Hospital, Alameda Health System

Oakland, California, 94602, United States

Location

Oklahoma State University, Center for Health Sciences

Tulsa, Oklahoma, 74107, United States

Location

CODA

Portland, Oregon, 97214, United States

Location

UTSW Medical Center, Center for Depression Research and Clinical Care

Dallas, Texas, 75247, United States

Location

University of Washington Medicine-Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Interventions

Buprenorphine

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Madhukar Trivedi
• Organization: UT Southwestern Medical Center

madhukar.trivedi@utsouthwestern.edu

214-648-0188

Study Officials

• Madhukar Trivedi, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the Data and Statistic Center (DSC) staff overseeing the random assignment schedule, a few Clinical Coordinating Center (CCC) staff, the central research pharmacy staff preparing the study medication and a single study staff role (Medical Personnel) to administer the injections are unblinded; all other study personnel and participants will remain blinded to treatment arm until the nationwide completion of the trial and the database is formally locked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 16, 2022
• Study Start: March 24, 2023
• Primary Completion: October 20, 2023
• Study Completion: November 19, 2023
• Last Updated: March 21, 2025
• Results First Posted: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After the study is complete and the data is analyzed
• Access Criteria: Study-specific de-identification notes will be posted on the website (URL provided here)

Locations

US (6)