Suvorexant to Reduce Symptoms of Nicotine Use

The University of Texas System (UT)

Status and phase

Completed

Phase 2

Conditions

Smoking Cessation

Treatments

Drug: Suvorexant 20 mg

Drug: Suvorexant 0mg

Study type

Interventional

Funder types

Other

Identifiers

NCT04234997

HSC-MS-19-0966

Details and patient eligibility

About

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

Enrollment

14 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.