Suvorexant as an Adjunct to Buprenorphine Induction and Maintenance in Persons Who Use Fentanyl
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Total Sleep Time
研究概览
简要总结
This is a 4-week, randomized-controlled trial of suvorexant vs placebo in persons with opioid use disorder who have recent fentanyl exposure. Participants will first undergo a 5-day residential phase wherein participants are stabilized on sublingual buprenorphine/naloxone, followed by a 3-week outpatient phase wherein participants are maintained on sublingual buprenorphine/naloxone and transitioned to extended-release buprenorphine).
详细描述
This study will enroll persons with opioid use disorder (N=120) who have recent fentanyl exposure (as assessed via urinalysis testing). Participants will be randomized to receive suvorexant or placebo for the duration of the study enrollment, which will serve as the between-groups experimental comparison. The study will consist of a brief (5 day) residential phase and 3-week outpatient phase. During the residential phase, all participants will be briefly maintained on a short acting opioid prior to induction onto sublingual (SL) buprenorphine (using either the buprenorphine or buprenorphine/naloxone product). At the end of the 5-day residential period, participants will be discharged to complete the ~3-week outpatient phase. During the outpatient period all participants will be maintained on SL buprenorphine/naloxone and continue to receive suvorexant or placebo, and at the end of the study participants will receive an injection of XR-buprenorphine (Sublocade). All buprenorphine procedures will be open label and will follow standard-of-care practices. Study medication during the outpatient period will be managed using an automated pill dispenser. Data collection will consist of forehead-based EEG monitoring, wrist-worn actigraphy/photoplethysmography, and questionnaires delivered during study visits or via cell-phone based ecological momentary assessments.
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)
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
- •Aged 18-65
- •Meets DSM-5 criteria for opioid use disorder (OUD) with evidence of physical dependence on opioids
- •Provides a urine sample that tests positive for fentanyl and/or fentanyl analogues
- •Interest in being maintained on buprenorphine for OUD
- •Plans to reside in current area for study period
- •Achieving a study maintenance dose of >=8mg sublingual buprenorphine/naloxone
- •Willing to comply with study protocol
- •Have no clinically significant chronic medical or surgical disorders or conditions that are judged by the investigators to prevent participation
排除标准
- •Medically contraindicated for buprenorphine, extended-release (XR)-buprenorphine (Sublocade), or suvorexant (as per medication labels)
- •Pregnant or breast feeding
- •Severe Diagnostic and Statistical Manual (DSM)-5 alcohol or benzodiazepine use disorder or evidence of alcohol/benzodiazepine physical dependence
- •Have a known allergy to the study medications
- •Past 30-day prescribed use of suvorexant for the indication of insomnia
- •Current benzodiazepine or other prescribed medication for the indication of insomnia
- •Urine sample testing positive for benzodiazepine at screening and admission to residential treatment
- •Current narcolepsy, restless leg syndrome or sleep paralysis
- •High risk for current sleep apnea
- •Current (past 30-day) suicidal behaviors
- •Severe hepatic or renal impairment
- •aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3x upper limit of normal (ULN)
- •Total bilirubin >2x ULN
- •Creatinine >1.5x ULN
- •Past year clinically-significant psychiatric condition judged to interfere with study participation
- •Lack of access to stable housing (necessary for electronic pill dispenser charging)
- •Have circumstances that would interfere with study participation (e.g., impending jail)
研究组 & 干预措施
Placebo
Nightly dosing of placebo
干预措施: Placebo (Drug)
Suvorexant
Nightly dosing of suvorexant
干预措施: Suvorexant (Drug)
结局指标
主要结局
Total Sleep Time
时间窗: 3 nights during the initial residential phase and 1 night at the end of outpatient treatment
Duration of nightly total sleep time in minutes, as measured by electroencephalography (EEG) and supplemented by actigraphy/photoplethysmography (e.g., if EEG malfunctions).
Buprenorphine compliance as assessed by the number of study days complying with buprenorphine treatment
时间窗: 25 days across residential and outpatient treatment
Buprenorphine compliance will be assessed by the number of study days complying with buprenorphine treatment.
次要结局
未报告次要终点