Suvorexant to Reduce Symptoms of Nicotine Use

Study Overview
=================
Brief Summary
-----------------
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

Official Title
-----------------
Suvorexant to Reduce Symptoms of Nicotine Use: A Double-blind, Placebo-controlled Study

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Drug: Suvorexant 20 mg
* Drug: Suvorexant 0mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non-treatment seeking cigarette smokers that report smoking atleast 10 cigarettes per day Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suvorexant 20 mg<br> | Drug: Suvorexant 20 mg<br>* Participants will be advised to take the medication at 10PM for 7 days.Participants will be instructed to stop smoking by 10 pm the day before, in order to ensure they meet the breath CO criterion (CO ≤ 4 ppm) indicating overnight abstinence.<br>|
| Placebo Comparator: Suvorexant 0mg<br> | Drug: Suvorexant 0mg<br>* Participants will be advised to take the medication at 10PM for 7 days.Participants will be instructed to stop smoking by 10 pm the day before, in order to ensure they meet the breath CO criterion (CO ≤ 4 ppm) indicating overnight abstinence.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in craving as assessed by a Visual Analog Scale (VAS) for Craving | The VAS scale ranges from 0(not at all) to 100(extreme craving);a higher score indicating a worse outcome | Day1,Day8 | 
| Change in stress as assessed by a Visual Analog Scale (VAS) for Stress | The VAS scale ranges from 0(not at all) to 10(extreme stress);a higher score indicating a worse outcome | Day1,Day8 | 
| Change in Stress Reactivity as assessed by Heart Rate During the Cold Pressor Test (CPT) |  | Day1,Day8 | 
| Change in Stress Reactivity as assessed by cortisol During the Cold Pressor Test (CPT) |  | Day1,Day8 | 
| Change in smoking as Assessed by Latency to Self-Administration during the Smoking Relapse Assessment |  | Day1,day8 | 
| Change in smoking as Assessed by Number of Self-Administrated Cigarettes during the Smoking Relapse Assessment |  | Day1,day8 | 
| Change in sleep quality as assessed by the Garmin Vivosmart3 Actigraphy Device | Quality defined as proportion of time in deep sleep | Day1,day8 | 
| Change in sleep duration as assessed by the Garmin Vivosmart3 Actigraphy Device | Duration as the total amount of time asleep | Day1,day8 | 
| Change in sleep restlessness as assessed by the Garmin Vivosmart3 Actigraphy Device | Restlessness as the number of times waking up during sleep | Day1,day8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in stress as assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Stress Subscale | 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). | Day1,day8 | 
| Change in stress as assessed by the Personal Stress Scale (PSS) | There are 10 questions ranging from a score of 0(never) to 4(very often) for a total maximum score of 40 | Day1,day8 | 
| Change in stress reactivity as assessed by Systolic Blood Pressure During the Cold Pressor Test (CPT) |  | Day1,day8 | 
| Change in stress reactivity as assessed by Diastolic Blood Pressure During the Cold Pressor Test (CPT) |  | Day1,day8 | 
| Change in sleep quality as assessed by the Patient-Reported Outcomes Measurement Information System(PROMIS) Sleep Disturbance Short Form | This scale ranges form 1(very much)to 5(not at all) | Day1,day8 | 
| Change in sleep quality as assessed by the Epworth Sleepiness Scale (ESS) | This scale ranges form 0(would never dose) to 3(high chance of dosing) | Day1,day8 | 
| Change in Withdrawal Severity as Assessed by the Minnesota Nicotine Withdrawal Questionnaire (MNWQ) | This scale contains 9 questions scored between 0-4 with higher scores meaning greater withdrawal symptoms | Day1,day8 |