Suvorexant to Reduce Symptoms of Nicotine Use

NCT ID: NCT04234997

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-23
• Study Completion Date: 2024-08-22

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Suvorexant 20 mg

Group Type: EXPERIMENTAL

Suvorexant 20 mg

Intervention Type: 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

Group Type: PLACEBO_COMPARATOR

Suvorexant 0mg

Intervention Type: 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.

Interventions

Suvorexant 20 mg

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.

Intervention Type: DRUG

Suvorexant 0mg

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Robert Suchting

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Suchting, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HSC-MS-19-0966

Identifier Type: -

Identifier Source: org_study_id