The Effects of Suvorexant on Sleep, Stress, and Cue-reactivity in Methamphetamine Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Self-reported Stress as Assessed by the Visual Analog Scale (VAS)
研究概览
简要总结
The purpose of this study is to determine the effects of SUVO on sleep, stress, and cue reactivity/craving and to evaluate the preliminary safety and side effects profile of suvorexant (SUVO)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
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 DSM-5 criteria for MA use disorder
- •Be fluent in English and able to understand the consent form
排除标准
- •Have an alcohol use disorder or report binge drinking (>7 drinks for women and >14 drinks for men)
- •Have a greater than mild substance use disorder on any other illicit 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., 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
1 week Placebo, then 1 week suvorexant (SUVO)
After 1 week of placebo treatment there will be 1 week of wash out period before start of study medication
干预措施: suvorexant (SUVO) (Drug)
1 week Placebo, then 1 week suvorexant (SUVO)
After 1 week of placebo treatment there will be 1 week of wash out period before start of study medication
干预措施: Placebo (Drug)
1 week suvorexant (SUVO), then 1 week Placebo
After 1 week of SUVO treatment there will be 1 week of wash out period before start of placebo
干预措施: suvorexant (SUVO) (Drug)
1 week suvorexant (SUVO), then 1 week Placebo
After 1 week of SUVO treatment there will be 1 week of wash out period before start of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Self-reported Stress as Assessed by the Visual Analog Scale (VAS)
时间窗: 7 days
The Visual Analog Scale is scored from 0-10, with 0 being no stress, 10 being extreme stress.
Self-reported Sleep as Assessed by the PITTSBURGH SLEEP QUALITY INDEX (PSQI)
时间窗: 7 days
Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21, higher score indicating a worse outcome. The global PSQI score is reported.
Resting State Alpha Power as Assessed by EEG
时间窗: 7 days
EEG will be used to assess electrical activity in the brain, specifically, to assess alpha power, which is the level of activity in the 8-12Hz frequency range. Resting state EEG means that EEG will be assessed during wakeful rest. Alpha power will be assessed in each of the 4 brain lobes (frontal, central, parietal, and occipital) for 3 minutes during eyes closed wakeful rest and also for 3 minutes during eyes open wakeful rest. Alpha Power will be reported in microvolts squared (μV²). Higher alpha power indicates more sleepiness and lower alpha power indicates less sleepiness
Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by the EEG
时间窗: 7 days
The Picture Viewing Task will be used to elicit the late positive potential (LPP), reflecting the motivational salience of a stimulus. During this task, participants are asked to view a slideshow of images including pleasant, unpleasant, neutral, and Methamphetamine-related images. The amplitude of the LPP in microvolts in response to visual stimuli is reported.
Self-reported Stress as Assessed by the Stress Subscale of the Depression, Anxiety and Stress Scale (DASS-21)
时间窗: 7 days
The Stress Subscale of the Depression, Anxiety and Stress scale (DASS-21) assesses stress levels. Total score on the DASS-21 stress subscale ranges from 0 to 21, with a higher score indicating greater stress.
Average Sleep Time Per Night Measured Nightly Via Actigraphy Watch Over 7 Nights
时间窗: 7 days
The average sleep time per night (averaged over 7 days) will be reported.
Average Time Awake After Sleep Onset Measured Nightly Via Actigraphy Watch Over 7 Nights
时间窗: 7 days
The average time awake after sleep onset per night (averaged over 7 days) will be reported.
Change of Cortisol Level
时间窗: baseline, about 32 minutes after the start of the cold pressor task
During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Saliva samples will be collected before and after the CPT, and cortisol levels in the saliva samples will be assessed. The change in cortisol level will be reported as \[(cortisol level at post cold pressor task) - (cortisol level pre cold pressor task)\].
次要结局
- Number of Participants Who Had Side Effects(7 days)
- Depression as Assessed by the Beck's Depression Inventory (BDI)Scale(7 days)
- Number of Days of Methamphetamine Use as Assessed by the Time Line Follow Back (TLFB) Method(7 days)
- Number of Participants Positive for Methamphetamine Use as Assessed by the Urine Drug Screen (UDS)(Day 7)
- Suicidal Ideation and Behavior as Assessed by the COLUMBIA-SUICIDE SEVERITY RATING SCALE (CSSR)(7 days)
研究者
Heather E. Webber, PhD
Assistant Professor
The University of Texas Health Science Center, Houston