Phase 2 N=11 Randomized Quadruple-blind Treatment

Suvorexant to Reduce Symptoms of Nicotine Use

Smoking Cessation

Bottom Line

View on ClinicalTrials.gov: NCT04234997 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2025

Primary outcome: Primary: Stress as Assessed by a Visual Analog Scale (VAS) for Stress — 3.4; 3 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Suvorexant 20 mg (Drug); Suvorexant 0mg (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center, Houston
Primary completion: Aug 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Stress as Assessed by a Visual Analog Scale (VAS) for Stress	3.33; 3.2	—
PRIMARY Stress as Assessed by a Visual Analog Scale (VAS) for Stress	3.33; 3.2	—
PRIMARY Change in Stress Reactivity as Assessed by Heart Rate During the Cold Pressor Test (CPT)	3.667; 9	—
PRIMARY Change in Stress Reactivity as Assessed by Heart Rate During the Cold Pressor Test (CPT)	3.667; 9	—
PRIMARY Change in Stress Reactivity as Assessed by Cortisol During the Cold Pressor Test (CPT)	—	—
PRIMARY Smoking as Assessed by Latency to Self-Administration During the Smoking Relapse Assessment	56.67; 16.2	—
PRIMARY Smoking as Assessed by Number of Self-Administrated Cigarettes During the Smoking Relapse Assessment	1.33; 1.4	—
PRIMARY Change in Sleep Quality as Assessed by the Garmin Vivosmart3 Actigraphy Device	-0.038; 0.4	—
PRIMARY Change in Sleep Duration as Assessed by the Garmin Vivosmart3 Actigraphy Device	-195.5; 79	—
PRIMARY Change in Sleep Restlessness as Assessed by the Garmin Vivosmart3 Actigraphy Device	0.5; 7	—
PRIMARY Smoking as Assessed by Number of Self-Administrated Cigarettes During the Smoking Relapse Assessment	1.33; 1.4	—
PRIMARY Smoking as Assessed by Latency to Self-Administration During the Smoking Relapse Assessment	56.67; 16.2	—
PRIMARY Nicotine Craving as Assessed by the Questionnaire of Smoking Urgers (QSU-brief)	47.67; 39.8	—
PRIMARY Nicotine Craving as Assessed by the Questionnaire of Smoking Urgers (QSU-brief)	47.67; 39.8	—
SECONDARY Stress as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Stress Subscale	1.33; 5.2	—
SECONDARY Stress as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Stress Subscale	1.33; 5.2	—
SECONDARY Stress as Assessed by the Personal Stress Scale (PSS)	18; 17.4	—
SECONDARY Stress as Assessed by the Personal Stress Scale (PSS)	18; 17.4	—
SECONDARY Change in Stress Reactivity as Assessed by Systolic Blood Pressure During the Cold Pressor Test (CPT)	18; 16	—
SECONDARY Change in Stress Reactivity as Assessed by Systolic Blood Pressure During the Cold Pressor Test (CPT)	18; 16	—
SECONDARY Change in Stress Reactivity as Assessed by Diastolic Blood Pressure During the Cold Pressor Test (CPT)	9.667; 14.8	—
SECONDARY Change in Stress Reactivity as Assessed by Diastolic Blood Pressure During the Cold Pressor Test (CPT)	9.667; 14.8	—
SECONDARY Sleep Quality as Assessed by the Patient-Reported Outcomes Measurement Information System(PROMIS) Sleep Disturbance Short Form	16; 21.4	—
SECONDARY Sleep Quality as Assessed by the Patient-Reported Outcomes Measurement Information System(PROMIS) Sleep Disturbance Short Form	16; 21.4	—
SECONDARY Sleep Quality as Assessed by the Epworth Sleepiness Scale (ESS)	12.67; 11	—
SECONDARY Sleep Quality as Assessed by the Epworth Sleepiness Scale (ESS)	12.67; 11	—
SECONDARY Withdrawal Severity as Assessed by the Minnesota Nicotine Withdrawal Questionnaire (MNWQ)	7; 11.6	—
SECONDARY Withdrawal Severity as Assessed by the Minnesota Nicotine Withdrawal Questionnaire (MNWQ)	7; 11.6	—
SECONDARY Anxiety a Measured by the Hamilton Anxiety Rating Scale (HAM-A)	2.33; 3	—
SECONDARY Anxiety a Measured by the Hamilton Anxiety Rating Scale (HAM-A)	2.33; 3	—
SECONDARY Sleep Quality as Assessed by the Pittsburgh Sleep Quality Index (PSQI)	7; 9.8	—
SECONDARY Sleep Quality as Assessed by the Pittsburgh Sleep Quality Index (PSQI)	7; 9.8	—
SECONDARY Anxiety as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Anxiety Subscale	0.67; 3	—
SECONDARY Anxiety as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Anxiety Subscale	0.67; 3	—
SECONDARY Change in Stress as Assessed by Visual Analog Scale (VAS) for Stress During the Cold Pressor Test (CPT)	1; -0.2	—
SECONDARY Change in Stress as Assessed by Visual Analog Scale (VAS) for Stress During the Cold Pressor Test (CPT)	1; -0.2	—

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04234997). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.