Monthly Injectable BUP for MA Use Disorder (MURB) Trial (NCT05283304) | Clinical Trial Compass
TerminatedPhase 2
Monthly Injectable BUP for MA Use Disorder (MURB) Trial
Stopped: Side effects of medication
United States18 participantsStarted 2023-03-24
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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;
Exclusion criteria
✕. 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;