Safety and Efficacy of Suvorexant for Opioid/Stimulant Co-use Among Individuals in Treatment for Opioid Use Disorder (OUD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Opioid Use: Proportion of Positive Urine Drug Screens (UDS)
研究概览
简要总结
This study will evaluate whether Suvorexant 20mg reduces drug use and craving, and improves sleep and stress among persons with co-occurring opioid use disorder and stimulant use disorder.
详细描述
This between-subjects, double-blinded, randomized controlled pilot study will recruit patients who are receiving methadone or buprenorphine treatment for OUD and are using cocaine. Participants will be randomly assigned to receive up to 30-days of Suvorexant (SUVO) or placebo. They will visit the clinic regularly to provide urine drug screens and complete questionnaires and will wear a device that can measure their sleep parameters. We expect that relative to persons who receive placebo, individuals who receive SUVO will 1) be less likely to screen positive for cocaine and/or opioids on urine drug screens, 2) will report lower drug craving, 3) will have longer total sleep time, 4) will report fewer insomnia symptoms, and 5) will report overall lower stress than persons who receive placebo. We also expect that patients will not have side effects from SUVO. These preliminary data will inform whether this FDA-approved medication may help patients stop co-using opioids and stimulants, which can be scaled up to reduce public health consequences related to 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
The research pharmacy will manage all randomization and blinding.
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
- •Ages 18-65,
- •Meet criteria for stimulant use disorder, based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR)
- •Currently receiving methadone or buprenorphine treatment for OUD and considered to be stable on current dose for at least 30 days
- •Willingness to engage with study protocol
- •Use of birth control (as appropriate)
- •Exclusion criteria:
- •Psychiatric or medical conditions that are judged by the investigators to interfere with participation or that are contraindicated for use with SUVO
- •Pregnant or breastfeeding
- •Current use of benzodiazepines, tranquilizers, or other schedule IV sleep medications
- •Moderate or severe substance use disorder other than opioid or stimulant use disorder
- •SUVO consumption in the last 30 days
- •Use of medications that are contraindicated with the study
- •Past 30-day suicidal behavior
- •Use of continuous positive airway pressure (CPAP) device for sleep apnea
排除标准
- 未提供
研究组 & 干预措施
Suvorexant
20mg Suvorexant
干预措施: Suvorexant (dual orexin receptor antagonist) (Drug)
Placebo
Placebo oral capsules
干预措施: Placebo (Drug)
结局指标
主要结局
Opioid Use: Proportion of Positive Urine Drug Screens (UDS)
时间窗: Up to 30 days post-randomization
Opioid use (measured via uranalysis for qualitative opioid assay) other than prescribed methadone or buprenorphine at scheduled study visits up to 30 days post-randomization (yes vs. no)
Cocaine Use: Proportion of Positive UDS Screens
时间窗: Up to 30 days post-randomization
Cocaine use (measured via uranalysis for qualitative cocaine assay) at scheduled study visits up to 30 days post-randomization.
次要结局
- Insomnia Severity Regression Slope(Up to 30 days post-randomization)
- Total Sleep Time (TST) Regression Slope(Up to 30 days post-randomization)
- Opioid Craving Visual Analog Scale (VAS) Regression Slope(Up to 30 days post-randomization)
- Cocaine Craving Visual Analog Scale (VAS) Regression Slope(Up to 30 days post-randomization)
- Perceived Stress Scale Regression Slope(Up to 30 days post-randomization)