Clinical trial NCT04234997: Suvorexant to Reduce Symptoms of Nicotine Use
Official title: Suvorexant to Reduce Symptoms of Nicotine Use: A Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking Cessation
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2020-01-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Change in craving as assessed by a Visual Analog Scale (VAS) for Craving
timeFrame: Day1,Day8
measure: Change in stress as assessed by a Visual Analog Scale (VAS) for Stress
timeFrame: Day1,Day8
measure: Change in Stress Reactivity as assessed by Heart Rate During the Cold Pressor Test (CPT)
timeFrame: Day1,Day8
measure: Change in Stress Reactivity as assessed by cortisol During the Cold Pressor Test (CPT)
timeFrame: Day1,Day8
measure: Change in smoking as Assessed by Latency to Self-Administration during the Smoking Relapse Assessment
timeFrame: Day1,day8
measure: Change in smoking as Assessed by Number of Self-Administrated Cigarettes during the Smoking Relapse Assessment
timeFrame: Day1,day8
measure: Change in sleep quality as assessed by the Garmin Vivosmart3 Actigraphy Device
timeFrame: Day1,day8
measure: Change in sleep duration as assessed by the Garmin Vivosmart3 Actigraphy Device
timeFrame: Day1,day8
measure: Change in sleep restlessness as assessed by the Garmin Vivosmart3 Actigraphy Device
timeFrame: Day1,day8
Secondary outcomes:
measure: Change in stress as assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Stress Subscale
timeFrame: Day1,day8
measure: Change in stress as assessed by the Personal Stress Scale (PSS)
timeFrame: Day1,day8
measure: Change in stress reactivity as assessed by Systolic Blood Pressure During the Cold Pressor Test (CPT)
timeFrame: Day1,day8
measure: Change in stress reactivity as assessed by Diastolic Blood Pressure During the Cold Pressor Test (CPT)
timeFrame: Day1,day8
measure: Change in sleep quality as assessed by the Patient-Reported Outcomes Measurement Information System(PROMIS) Sleep Disturbance Short Form
timeFrame: Day1,day8
measure: Change in sleep quality as assessed by the Epworth Sleepiness Scale (ESS)
timeFrame: Day1,day8
measure: Change in Withdrawal Severity as Assessed by the Minnesota Nicotine Withdrawal Questionnaire (MNWQ)
timeFrame: Day1,day8
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Robert Suchting, MD
role: PRINCIPAL_INVESTIGATOR
References: