Randomized, Double-blind, Placebo-controlled Trial of Monthly Injectable Buprenorphine (BUP) for Methamphetamine (MA) Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 6
- 主要终点
- Number of Methamphetamine-negative Urine Samples
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •Have other medical, psychiatric or other factors that in the judgment of the Medical Clinician could make participation difficult or unsafe.
研究组 & 干预措施
Injectable Buprenorphine (BUP-inj)
Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable buprenorphine (300 mg dose) every 4 weeks
干预措施: Buprenorphine injection (BUP-Inj) (Drug)
Injectable Placebo (PBO-inj)
Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable placebo (300 mg dose) every 4 weeks.
干预措施: Placebo injection (Other)
结局指标
主要结局
Number of Methamphetamine-negative Urine Samples
时间窗: weeks 9-12
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.
次要结局
- 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)
- Number of Days of MA and Opioid Co-use During the Medication Phase(weeks 1-12)
研究者
Madhukar H. Trivedi, MD
PROFESSOR
University of Texas Southwestern Medical Center