Smoking Cessation Clinical Trial
Official title:
Suvorexant to Reduce Symptoms of Nicotine Use: A Double-blind, Placebo-controlled Study
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
Status | Recruiting |
Enrollment | 20 |
Est. completion date | September 1, 2024 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas Health Science Center at Houston | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | Change in Stress Reactivity as assessed by Heart Rate During the Cold Pressor Test (CPT) | Day1,Day8 | ||
Primary | Change in Stress Reactivity as assessed by cortisol During the Cold Pressor Test (CPT) | Day1,Day8 | ||
Primary | Change in smoking as Assessed by Latency to Self-Administration during the Smoking Relapse Assessment | Day1,day8 | ||
Primary | Change in smoking as Assessed by Number of Self-Administrated Cigarettes during the Smoking Relapse Assessment | Day1,day8 | ||
Primary | Change in sleep quality as assessed by the Garmin Vivosmart3 Actigraphy Device | Quality defined as proportion of time in deep sleep | Day1,day8 | |
Primary | Change in sleep duration as assessed by the Garmin Vivosmart3 Actigraphy Device | Duration as the total amount of time asleep | Day1,day8 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Change in stress reactivity as assessed by Systolic Blood Pressure During the Cold Pressor Test (CPT) | Day1,day8 | ||
Secondary | Change in stress reactivity as assessed by Diastolic Blood Pressure During the Cold Pressor Test (CPT) | Day1,day8 | ||
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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