Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder: A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in wake after sleep onset measured via actigraphy watch
研究概览
简要总结
The purpose of this study is to determine the effects of suvorexant (SUVO), on sleep, stress, and drug craving during early abstinence from stimulants and to determine the effects of treatment (SUVO vs. treatment as usual (TAU)) on post-treatment (Days 13-30) residential program length of stay (LOS) and completion rate.
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
- None
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
- •Meet Diagnostic and Statistical Manual of Mental Disorders(DSM-5)criteria for primary stimulant use disorder (either cocaine or methamphetamine)
- •Be fluent in English and able to understand the consent form
排除标准
- •Have an opioid use disorder of any severity
- •Have a greater than moderate substance use disorder on any other substance
- •Undergoing medication-assisted treatment for withdrawal of any substance
- •Have any medical conditions contraindicating SUVO (e.g., severe pulmonary disease, severe cardiovascular disease or clinically abnormal ECG, severe liver or kidney disease, seizure disorder, or sleep disorder -particularly narcolepsy)
- •Are currently taking medications with known drug interactions with SUVO (e.g., Monoamine oxidase (MAO) inhibitors, anticonvulsants, haloperidol, phenothiazines, anesthetics, and any sedative)
- •Are pregnant or breast feeding
- •BMI > 30 (women only)
- •Have a current DSM-5 psychiatric disorder or neurological disease requiring on-going treatment that would make participation unsafe
- •Have history of seizure disorder
- •Have a head injury with loss of consciousness in the last 5 years
研究组 & 干预措施
SUVO
干预措施: SUVO (Drug)
SUVO
干预措施: TAU (Drug)
TAU
干预措施: TAU (Drug)
结局指标
主要结局
Change in wake after sleep onset measured via actigraphy watch
时间窗: Baseline (Day 4), Day 5, day 6, day 7, day 8, day 9, day 10, day 11
Changes in self reported Sleep-Related Impairment as assessed by the Patient Reported Outcomes Measurement Information System Short Form (PROMIS-SF)
时间窗: Day 5 and Day 12
This is an 8 item questionnaire and each is scored from 1-5 for a total score range of 8-40, higher number indicating worse outcome
Change in total sleep duration as assessed by the actigraphy watch
时间窗: Baseline (Day 4), Day 5, day 6, day 7, day 8, day 9, day 10, day 11
Change in self-reported stress as assessed by the Visual Analog Scale (VAS)
时间窗: Day 5 and Day 12
This is measured from 0=no stress, 10=extreme stress
Change in self reported sleep quality as assessed by the Insomnia Severity Index (ISI)
时间窗: Day 5 and Day 12
This is a 7 item questionnaire and is rated on a five-point Likert scale ('0' representing none or not at all and '4' representing very much). Total scores range from 0 to 28, with higher combined scores indicating worse insomnia severity.
Changes in self reported sleep disturbance as assessed by the Patient Reported Outcomes Measurement Information System Short Form (PROMIS-SF)
时间窗: Day 5 and Day 12
This is a 4 item questionnaire and each is scored from 1-5 for a score range of 4-20, higher number indicating worse outcome
Change in stress and anxiety as assessed by the Depression, Anxiety and Stress Scale (DASS)
时间窗: Day 5 and Day 12
The DASS 21 is a 21 item self report questionnaire. Each item is scored from 0 (did not apply to me at all over the last week) to 3 (applied to me very much or most of the time over the past week), higher score indicating a worse outcome
Change in craving as assessed by the self reported Stimulant Craving Questionnaire (STCQ)
时间窗: Day 5 and Day 12
This is a 10 item questionnaire, each is scored from 0 (strongly disagree) to 6 (strongly agree) for a total score range of 0-60, higher score indicating worse outcome
次要结局
- Change in stress as indicated by the change in heart rate during the cold-pressor task(Day 5 and Day 12)
- Change in stress as indicated by the change in diastolic blood pressure during the cold-pressor task for upto 2 minutes(Day 5 and Day 12)
- Percentage of participants who complete the 30 day treatment(at time of discharge (up to 30 days form baseline))
- Change in the amplitude of the Reward Positivity (RewP) component in microvolts in response to feedback on the Doors Task(Day 5 and Day 12)
- Change in intensity of demand as assessed by the Drug Purchasing Task(Day 5 and Day 12)
- Change in resting state alpha power as assessed by EEG(Day 5 and Day 12)
- Change in side effects as assessed by the side effects questionnaire(Day 5 , Day 12)
- Change in stress as indicated by the amount of cortisol present in saliva during the cold-pressor task(Day 5 and Day 12)
- Change in stress as indicated by the change in systolic blood pressure during the cold-pressor task for upto 2 minutes(Day 5 and Day 12)
- Length of stay (LOS)(at time of discharge (up to 30 days form baseline))
研究者
Heather E. Webber, PhD
Assistant Professor
The University of Texas Health Science Center, Houston