Dual-Orexin Antagonism as a Mechanism for Improving Sleep and Drug Abstinence in Opioid Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Opioid abstinence
研究概览
简要总结
Summary of Study Protocol. This project is designed to test neurobehavioral mechanisms underlying effects of the dual orexin-1/2 receptor antagonist suvorexant on sleep efficiency and opioid abstinence, and whether these outcomes are independent of one another. This will be the first study to investigate whether suvorexant improves outpatient opioid abstinence and sleep efficiency; and whether improving sleep mediates the improved opioid abstinence outcome. 120 participants with opioid use disorder (OUD) will complete this intent-to-treat study.
详细描述
Study Design. Using a placebo-controlled, parallel-group, randomized clinical trial design, we will prospectively evaluate whether nightly treatment with the orexin-1/2 receptor antagonist suvorexant (20 mg/day PO), relative to placebo, can increase outpatient opioid abstinence and improve sleep efficiency (sleep time per time-in-bed) as a mediator/moderator among patients with OUD. We include current medication for treating OUD, as well as treatment site, as stratification factors in the group allocation. Using power and sample size calculations, we estimate that 120 participants will suffice to test our hypotheses.
The study aims to test three co-primary hypotheses:
Hypothesis 1: Relative to placebo, suvorexant (20 mg/day) will significantly increase percentage opioid abstinence during outpatient weeks 1-13.
Hypothesis 2: Relative to placebo, suvorexant will improve sleep efficiency.
Hypothesis 3: Higher inpatient sleep efficiency will be associated with increased outpatient opioid abstinence (independent of experimental group assignment).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Suvorexant (20mg) and placebo research tablets will appear identical.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years old
- •Males and non-pregnant females who agree to medically accepted birth control for the duration of the study
- •Meet DSM-5 criteria for opioid use disorder (any severity level) alone or comorbid with stable medical diseases (except for certain medications [see below])
排除标准
- •Body mass index >38
- •Acute/unstable illness: conditions making it unsafe for participation, conditions with potential to disturb sleep (i.e. acute pain, respiratory infection)
- •Chronic illnesses; renal failure, liver disease, seizures, and dementing illnesses
- •Current psychiatric disease: psychosis, bipolar disorder, PTSD
- •Smoking during the night (11pm-7am). Nicotine replacement therapy is allowed
- •Medications including anxiolytics, hypnotics (both prescription and OTC), sedating antidepressants, anticonvulsants, sedating H1 antihistamines (non-sedating second generation H4 antihistamines are allowed), systemic steroids, respiratory stimulants and decongestants, prescription and OTC stimulants, prescription and OTC diet aids, herbal preparations, and narcotic analgesics. All medications and doses will be documented
- •Sleep-disordered breathing and periodic leg movements (PLMs) defined as ≥ 10 apnea-hypopneas or PLM events related to EEG arousal per hour of sleep time, or any other primary sleep (e.g. narcolepsy, restless legs syndrome) or circadian disorder
- •Night-shift work, which would alter circadian rhythm and be a confound in this trial.
研究组 & 干预措施
Suvorexant placebo
Placebo (inert) tablet
干预措施: Suvorexant Placebo (Drug)
Suvorexant 20mg
Suvorexant 20mg tablet
干预措施: Suvorexant (Drug)
结局指标
主要结局
Opioid abstinence
时间窗: up to 13 weeks
Percentage of opioid-free urine drug screens (UDS)
Sleep efficiency
时间窗: Sleep efficiency is measured on the evening of the first medication dose
Sleep efficiency equals sleep time (determined by standardized scoring of electroencephalogram recordings) divided by time in bed
次要结局
- Daily sleep questionnaire(Change in sleep quality scores from inpatient stay to outpatient weeks 2, 6 and 10)
- Actigraphic assessment of sleep(Change in total activity counts across outpatient weeks 2, 6 and 10)
- Urinary cortisol(Measured at 11pm on nights 4, 6, 8 (coordinated with sleep efficiency and melatonin assessments) and the following day (7am and 3pm on days 5, 7, 9) on the inpatient unit)
- Medication satisfaction(Change in medication satisfaction score across outpatient weeks 4, 8, and 12)
- Short Form-36 v2 Health Survey(Change in overall health total score across outpatient weeks 4, 8, and 12)
- Urinary melatonin(Measured at 11pm on nights 4, 6, 8 (coordinated with sleep efficiency and cortisol assessments) and the following day (7am and 3pm on days 5, 7, 9) on the inpatient unit)
- Timeline followback interview assessment of substance use(Once weekly (in conjunction with urine drug screen) on outpatient weeks 1 through 13)
- Clinical Global Impression (CGI)(Change in CGI subscale scores across outpatient weeks 4, 8, and 12)
- Weekly sleep questionnaire(Change in sleep quality scores across outpatient weeks 1, 4, 8 and 12)
研究者
Mark Greenwald, PhD
Professor of Psychiatry and Behavioral Neurosciences; and Director, Substance Abuse Research Division
Wayne State University