Medical Management of Sleep Disturbance During Opioid Tapering
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Total Sleep Time During Buprenorphine Taper
研究概览
简要总结
This study will evaluate whether a dual orexin-receptor antagonist approved by the FDA for sleep disturbance, suvorexant (SUVO; Belsomra), will increase total sleep time in patients with opioid use disorder (OUD) undergoing supervised withdrawal. This study is designed as a dose-finding study of SUVO compared to placebo. Briefly, OUD patients seeking supervised withdrawal will be admitted into a clinical research unit and stabilized onto buprenorphine for three days before being randomly assigned to study condition. All participants will then undergo a routine four-day buprenorphine taper, followed by a four-day post-taper phase. Participants will be randomized to receive either placebo, Low Dose SUVO, or High Dose SUVO and the investigators hypothesize that one or both doses of SUVO will improve total sleep time relative to placebo. Patients will attend a single follow-up session, 5-10 days following discharge.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years old and above
- •Meets Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for OUD with evidence of physical dependence on opioids, and seeking treatment to stop using illicit opioids.
- •Provides a urine sample that tests positive for opioids.
- •Willing to comply with the 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
- •Seeking or currently enrolled in methadone or buprenorphine maintenance treatment for OUD
- •Pregnant or breast feeding
- •Have evidence of physical dependence on alcohol or benzodiazepines that requires medical detoxification
- •Have a known allergy to the study medications
- •Past 30-day prescribed use of suvorexant or benzodiazepines for the indication of insomnia
- •Current use of a Selective Serotonin Reuptake Inhibitor (SSRI) or Monoamine oxidase (MAO) inhibitor for depression or insomnia, or other medications that are contraindicated with suvorexant
- •Current narcolepsy, restless leg syndrome or sleep paralysis
- •High risk for current sleep apnea
- •Current major depressive disorder
- •Past year suicidal behavior
- •Severe hepatic or renal impairment
- •Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) >3x ULN
- •Total bilirubin >2x Upper Limit of Normal (ULN)
- •Creatinine >1.5x ULN
- •Have circumstances that would interfere with study participation (e.g., impending jail)
研究组 & 干预措施
Placebo
Placebo sleep medication (Placebo oral capsule)
干预措施: Placebo oral capsule (Drug)
Low Dose Suvorexant
Low dose sleep medication
干预措施: Low Dose Suvorexant (Drug)
High Dose Suvorexant
High dose sleep medication
干预措施: High Dose Suvorexant (Drug)
结局指标
主要结局
Total Sleep Time During Buprenorphine Taper
时间窗: Four nights during a buprenorphine taper
Area-under-the-curve scores of total number of minutes slept per night as measured by a 3-lead wireless electroencephalography and wrist worn actigraphy.
Subjective Opiate Withdrawal Scale During Buprenorphine Taper
时间窗: Three days during a buprenorphine taper
Area-under-the-curve of peak daily scores on the Subjective Opiate Withdrawal Scale (SOWS) (a 16-item self-reported scale that measures individual opioid withdrawal symptoms using a 0-4 Likert scale; total range of SOWS is 0-64; lower scores indicate mild opioid withdrawal relative to higher scores which indicate more severe opioid withdrawal).
Total Sleep Time During Post-taper
时间窗: Four nights following buprenorphine discontinuation
Area-under-the-curve scores of total number of minutes slept per night as measured by a 3-lead wireless electroencephalography and wrist worn actigraphy.
Subjective Opiate Withdrawal Scale During Post-taper
时间窗: Three days following buprenorphine discontinuation
Area-under-the-curve of peak daily scores on the Subjective Opiate Withdrawal Scale (SOWS) (a 16-item self-reported scale that measures individual opioid withdrawal symptoms using a 0-4 Likert scale; total range of SOWS is 0-64; lower scores indicate mild opioid withdrawal relative to higher scores which indicate more severe opioid withdrawal).
Abuse Liability as Assessed by Visual Analogue Scale
时间窗: 4 nights
Area-under-the-curve of self-reported feelings of drug "High" on the morning after study drug administration, measured each morning on a 0-100 point visual analogue scale of the question "Last night, did you feel HIGH?". A score of "0" indicates no abuse liability and a score of 100 indicates extreme abuse liability. This will be assessed over four nights during an opioid taper.
次要结局
未报告次要终点