Suvorexant to Reduce Symptoms of Nicotine Use

NCT04234997 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: HSC-MS-19-0966
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (14)

• Stress as Assessed by a Visual Analog Scale (VAS) for Stress

  The VAS total score ranges from 1(none) to 10(extreme stress);a higher score indicating a worse outcome.

  Day 1

• Stress as Assessed by a Visual Analog Scale (VAS) for Stress

  The VAS total score ranges from 1(none) to 10(extreme stress);a higher score indicating a worse outcome.

  Day 8

• Change in Stress Reactivity as Assessed by Heart Rate During the Cold Pressor Test (CPT)

  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 \[(Heart rate post cold pressor task) - (Heart rate pre cold pressor task)\].

  Day 1 baseline (about 15 minutes before cold pressor task) and about 2 minutes after the start of the cold pressor task

• Change in Stress Reactivity as Assessed by Heart Rate During the Cold Pressor Test (CPT)

  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 \[(Heart rate post cold pressor task) - (Heart rate pre cold pressor task)\].

  Day 8 baseline (about 15 minutes before cold pressor task) and about 2 minutes after the start of the cold pressor task

• Change in Stress Reactivity as Assessed by Cortisol During the Cold Pressor Test (CPT)

  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 \[(cortisol level at post cold pressor task) - (cortisol level pre cold pressor task)\].

  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

• Smoking as Assessed by Latency to Self-Administration During the Smoking Relapse Assessment

  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.

  Day 1

• Smoking as Assessed by Number of Self-Administrated Cigarettes During the Smoking Relapse Assessment

  The outcome measure is the number of cigarettes self-administered by each participant during the Smoking Relapse Assessment.

  Day 1

• Change in Sleep Quality as Assessed by the Garmin Vivosmart3 Actigraphy Device

  Quality defined as proportion of time in deep sleep. Change in sleep quality is reported as \[(Day 8 Sleep Quality ) - (Day 1 Sleep quality)\]

  Day 1, Day 8

• Change in Sleep Duration as Assessed by the Garmin Vivosmart3 Actigraphy Device

  Duration as the total amount of time asleep. Change in sleep duration is reported as \[(Day 8 Sleep Duration ) - (Day 1 Sleep Duration)\]

  Day 1, Day 8

• Change in Sleep Restlessness as Assessed by the Garmin Vivosmart3 Actigraphy Device

  Restlessness as the number of times waking up during sleep. Change in sleep restlessness is reported as \[(Day 8 Sleep restlessness) - (Day 1 Sleep restlessness\]

  Day 1, Day 8

• Smoking as Assessed by Number of Self-Administrated Cigarettes During the Smoking Relapse Assessment

  The outcome measure is the number of cigarettes self-administered by each participant during the Smoking Relapse Assessment.

  Day 8

• Smoking as Assessed by Latency to Self-Administration During the Smoking Relapse Assessment

  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.

  Day 8

• Nicotine Craving as Assessed by the Questionnaire of Smoking Urgers (QSU-brief)

  The Questionnaire of Smoking Urgers (QSU-brief) total score ranges from 10 to 70, higher score indicates greater nicotine craving.

  Day 1

• Nicotine Craving as Assessed by the Questionnaire of Smoking Urgers (QSU-brief)

  The Questionnaire of Smoking Urgers (QSU-brief) total score ranges from 10 to 70, higher score indicates greater nicotine craving.

  Day 8

Secondary Outcomes (22)

• Stress as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Stress Subscale

  Day 1

• 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 1

• 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 1 baseline (about 15 minutes before cold pressor task) and about 2 minutes after the start of the cold pressor task

Study Arms (2)

Suvorexant 20 mg

EXPERIMENTAL

Drug: Suvorexant 20 mg

Suvorexant 0mg

PLACEBO COMPARATOR

Drug: Suvorexant 0mg

Interventions

Suvorexant 20 mg DRUG

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.

Suvorexant 20 mg

Suvorexant 0mg DRUG

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.

Suvorexant 0mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non-treatment seeking cigarette smokers that report smoking atleast 10 cigarettes per day

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

suvorexant

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Results Point of Contact

• Title: Robert Suchting, MD
• Organization: The University of Texas Health Science Center at Houston

Robert.Suchting@uth.tmc.edu

713-486-2521

Study Officials

• Robert Suchting, Ph.D.

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 21, 2020
• Study Start: August 23, 2021
• Primary Completion: August 22, 2024
• Study Completion: August 22, 2024
• Last Updated: October 1, 2025
• Results First Posted: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)