Suvorexant to Reduce Symptoms of Nicotine Use: A Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Stress as Assessed by a Visual Analog Scale (VAS) for Stress
研究概览
简要总结
The purpose of this study is to assess the impact of suvorexant on established measures of smoking relapse risk (craving,withdrawal, stress reactivity, latency to self-administration) and to validate the somnolent effect of suvorexant on sleep metrics in a sample of individuals with tobacco use disorder
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
- •non-treatment seeking cigarette smokers that report smoking atleast 10 cigarettes per day
排除标准
- •greater than mild substance use disorder on drugs other than nicotine
- •a Diagnostic and Statistical Manual of Mental Disorders(DSM)-IV axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
- •significant current suicidal or homicidal ideation - medical conditions contraindicating administration of suvorexant (e.g., severe pulmonary disease, severe cardiovascular disease or clinically abnormal EEG, severe liver or kidney disease, seizure disorder, or sleep disorder - particularly narcolepsy)
- •taking medications known to have significant drug interactions with the study medication(s) (e.g., Monoamine oxidase inhibitors(MAO) inhibitors, anticonvulsants, haloperidol, phenothiazines, anesthetics, and all sedatives)
- •currently or recently (last 3 months) treated for substance use [other than nicotine] or another psychiatric condition
- •conditions of probation or parole requiring reports of drug use to officers of the court
- •impending incarceration
- •pregnant or nursing for female patients
- •inability to read, write, or speak English [required for lab tasks and psychometric scales]
- •unwillingness to sign a written informed consent form
- •subjects with alcohol use disorders or report recent problem drinking (5/4 drinks for males/females in < 2.5 hours or > 10 alcoholic drinks per week)
- •any illness,condition, or use of medications which in the opinion of the PI and/or admitting physician would preclude safe and/or successful completion of the study.
研究组 & 干预措施
Suvorexant 20 mg
干预措施: Suvorexant 20 mg (Drug)
Suvorexant 0mg
干预措施: Suvorexant 0mg (Drug)
结局指标
主要结局
Stress as Assessed by a Visual Analog Scale (VAS) for Stress
时间窗: Day 8
The VAS total score ranges from 1(none) to 10(extreme stress);a higher score indicating a worse outcome.
Change in Stress Reactivity as Assessed by Heart Rate During the Cold Pressor Test (CPT)
时间窗: Day 8 baseline (about 15 minutes before cold pressor task) and about 2 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. Heart rate will be collected pre CPT (about 15 minutes before cold pressor task) and post CPT (about 2 minutes after the start of the cold pressor task). The change in Heart rate will be reported as \[(Heart rate post cold pressor task) - (Heart rate pre cold pressor task)\].
Change in Stress Reactivity as Assessed by Cortisol During the Cold Pressor Test (CPT)
时间窗: Day 1 baseline (about 15 minutes before cold pressor task) and about 30 minutes after the start of the cold pressor task, Day 8 baseline (about 15 minutes before cold pressor task) and about 30 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 pre CPT (about 15 minutes before cold pressor task) and post CPT (about 30 minutes after the start of the cold pressor task), and cortisol levels in the saliva samples will be assessed. The change in cortisol level will be reported as \[(cortisol level at post cold pressor task) - (cortisol level pre cold pressor task)\].
Smoking as Assessed by Latency to Self-Administration During the Smoking Relapse Assessment
时间窗: Day 8
Latency to self-administration is defined as the time (in minutes) from the beginning of the relapse assessment session until the participant initiates smoking their first cigarette.
Smoking as Assessed by Number of Self-Administrated Cigarettes During the Smoking Relapse Assessment
时间窗: Day 8
The outcome measure is the number of cigarettes self-administered by each participant during the Smoking Relapse Assessment.
Change in Sleep Quality as Assessed by the Garmin Vivosmart3 Actigraphy Device
时间窗: Day 1, Day 8
Quality defined as proportion of time in deep sleep. Change in sleep quality is reported as \[(Day 8 Sleep Quality ) - (Day 1 Sleep quality)\]
Change in Sleep Duration as Assessed by the Garmin Vivosmart3 Actigraphy Device
时间窗: Day 1, Day 8
Duration as the total amount of time asleep. Change in sleep duration is reported as \[(Day 8 Sleep Duration ) - (Day 1 Sleep Duration)\]
Change in Sleep Restlessness as Assessed by the Garmin Vivosmart3 Actigraphy Device
时间窗: Day 1, Day 8
Restlessness as the number of times waking up during sleep. Change in sleep restlessness is reported as \[(Day 8 Sleep restlessness) - (Day 1 Sleep restlessness\]
Nicotine Craving as Assessed by the Questionnaire of Smoking Urgers (QSU-brief)
时间窗: Day 8
The Questionnaire of Smoking Urgers (QSU-brief) total score ranges from 10 to 70, higher score indicates greater nicotine craving.
次要结局
- Stress as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Stress Subscale(Day 8)
- Stress as Assessed by the Personal Stress Scale (PSS)(Day 8)
- Change in Stress Reactivity as Assessed by Systolic Blood Pressure During the Cold Pressor Test (CPT)(Day 8 baseline (about 15 minutes before cold pressor task) and about 2 minutes after the start of the cold pressor task)
- Sleep Quality as Assessed by the Patient-Reported Outcomes Measurement Information System(PROMIS) Sleep Disturbance Short Form(Day 8)
- Change in Stress Reactivity as Assessed by Diastolic Blood Pressure During the Cold Pressor Test (CPT)(Day 8 baseline (about 15 minutes before cold pressor task) and about 2 minutes after the start of the cold pressor task)
- Sleep Quality as Assessed by the Epworth Sleepiness Scale (ESS)(Day 8)
- Withdrawal Severity as Assessed by the Minnesota Nicotine Withdrawal Questionnaire (MNWQ)(Day 8)
- Anxiety a Measured by the Hamilton Anxiety Rating Scale (HAM-A)(Day 8)
- Sleep Quality as Assessed by the Pittsburgh Sleep Quality Index (PSQI)(Day 8)
- Anxiety as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Anxiety Subscale(Day 8)
- Change in Stress as Assessed by Visual Analog Scale (VAS) for Stress During the Cold Pressor Test (CPT)(Day 8 baseline (about 15 minutes before cold pressor task) and about 30 minutes after the start of the cold pressor task)
研究者
Robert Suchting
Assistant Professor
The University of Texas Health Science Center, Houston