Smoking CessationPhase 2NCT04234997
Suvorexant to Reduce Symptoms of Nicotine Use
A Phase 2 study testing Suvorexant 20 mg and Suvorexant 0mg in people with Smoking Cessation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Suvorexant 20 mg and Suvorexant 0mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2021to 22 Aug 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non-treatment seeking cigarette smokers that report smoking atleast 10 cigarettes per day
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Suvorexant to Reduce Symptoms of Nicotine Use: A Double-blind, Placebo-controlled Study
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
- Being tested
- Suvorexant 20 mg, Suvorexant 0mg
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suvorexant 20 mgDrug
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 0mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Suvorexant 20 mg | Experimental | Not described Receives: Drug: Suvorexant 20 mg |
| Suvorexant 0mg | Placebo comparator | Not described Receives: Drug: Suvorexant 0mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)].
Measured: 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)].
Measured: 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)].
Measured: 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.
Measured: 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.
Measured: 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)]
Measured: 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)]
Measured: 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]
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 8
Secondary outcomes (22)
Stress as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Stress Subscale
The Stress Subscale of the Depression, Anxiety and Stress scale (DASS-21) assesses stress levels. Total score on the DASS-21 stress subscale ranges from 0 to 21, with a higher score indicating higher stress.
Measured: Day 1
Stress as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Stress Subscale
The Stress Subscale of the Depression, Anxiety and Stress scale (DASS-21) assesses stress levels. Total score on the DASS-21 stress subscale ranges from 0 to 21, with a higher score indicating higher stress.
Measured: Day 8
Stress as Assessed by the Personal Stress Scale (PSS)
The Personal Stress Scale (PSS) total score ranges from 0 to 40, a higher score indicating greater stress.
Measured: Day 1
Stress as Assessed by the Personal Stress Scale (PSS)
The Personal Stress Scale (PSS) total score ranges from 0 to 40, a higher score indicating greater stress.
Measured: Day 8
Change in Stress Reactivity as Assessed by Systolic Blood Pressure 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. Systolic Blood Pressure 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 Systolic Blood Pressure will be reported as [( Systolic Blood Pressure at post cold pressor task) - (Systolic Blood Pressure at pre cold pressor task)].
Measured: 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 Systolic Blood Pressure 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. Systolic Blood Pressure 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 Systolic Blood Pressure will be reported as [( Systolic Blood Pressure at post cold pressor task) - (Systolic Blood Pressure at pre cold pressor task)].
Measured: 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 Diastolic Blood Pressure 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. Diastolic Blood Pressure 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 Diastolic Blood Pressure will be reported as [( Diastolic Blood Pressure at post cold pressor task) - (Diastolic Blood Pressure at pre cold pressor task)].
Measured: 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 Diastolic Blood Pressure 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. Diastolic Blood Pressure 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 Diastolic Blood Pressure will be reported as [( Diastolic Blood Pressure at post cold pressor task) - (Diastolic Blood Pressure at pre cold pressor task)].
Measured: Day 8 baseline (about 15 minutes before cold pressor task) and about 2 minutes after the start of the cold pressor task
Sleep Quality as Assessed by the Patient-Reported Outcomes Measurement Information System(PROMIS) Sleep Disturbance Short Form
Patient-Reported Outcomes Measurement Information System(PROMIS) Sleep Disturbance Short Form total score ranges from 8 to 40, a higher score indicating worse sleep quality.
Measured: Day 1
Sleep Quality as Assessed by the Patient-Reported Outcomes Measurement Information System(PROMIS) Sleep Disturbance Short Form
Patient-Reported Outcomes Measurement Information System(PROMIS) Sleep Disturbance Short Form total score ranges from 8 to 40, a higher score indicating worse sleep quality.
Measured: Day 8
Sleep Quality as Assessed by the Epworth Sleepiness Scale (ESS)
The Epworth Sleepiness Scale (ESS) total score ranges from 0 to 24, a higher score indicating worse sleep quality.
Measured: Day 1
Sleep Quality as Assessed by the Epworth Sleepiness Scale (ESS)
The Epworth Sleepiness Scale (ESS) total score ranges from 0 to 24, a higher score indicating worse sleep quality.
Measured: Day 8
Withdrawal Severity as Assessed by the Minnesota Nicotine Withdrawal Questionnaire (MNWQ)
The Minnesota Nicotine Withdrawal Questionnaire (MNWQ) total score ranges from 0 to 36 with higher scores indicating greater withdrawal symptoms.
Measured: Day 1
Withdrawal Severity as Assessed by the Minnesota Nicotine Withdrawal Questionnaire (MNWQ)
The Minnesota Nicotine Withdrawal Questionnaire (MNWQ) total score ranges from 0 to 36 with higher scores indicating greater withdrawal symptoms.
Measured: Day 8
Anxiety a Measured by the Hamilton Anxiety Rating Scale (HAM-A)
The Hamilton Anxiety Rating Scale (HAM-A) total score ranges from 0 to 56, a higher score indicating greater anxiety.
Measured: Day 1
Anxiety a Measured by the Hamilton Anxiety Rating Scale (HAM-A)
The Hamilton Anxiety Rating Scale (HAM-A) total score ranges from 0 to 56, a higher score indicating greater anxiety.
Measured: Day 8
Sleep Quality as Assessed by the Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) total score ranges from 0 to 21, a higher score indicates worse sleep quality.
Measured: Day 1
Sleep Quality as Assessed by the Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) total score ranges from 0 to 21, a higher score indicates worse sleep quality.
Measured: Day 8
Anxiety as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Anxiety Subscale
The Anxiety Subscale of the Depression, Anxiety and Stress scale (DASS-21) assesses anxiety levels. Total score on the DASS-21 stress subscale ranges from 0 to 21, with a higher score indicating greater anxiety.
Measured: Day 1
Anxiety as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Anxiety Subscale
The Anxiety Subscale of the Depression, Anxiety and Stress scale (DASS-21) assesses anxiety levels. Total score on the DASS-21 stress subscale ranges from 0 to 21, with a higher score indicating greater anxiety.
Measured: Day 8
Change in Stress as Assessed by Visual Analog Scale (VAS) for Stress 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. The VAS total score ranges from 1(none) to 10(extreme stress);a higher score indicating a worse outcome. Visual Analog Scale (VAS) for stress score will be collected before and after the CPT. The change in Stress will be reported as [( Visual Analog Scale (VAS) for stress score at post cold pressor task) - (Visual Analog Scale (VAS) for stress score at pre cold pressor task)].
Measured: Day 1 baseline (about 15 minutes before cold pressor task) and about 30 minutes after the start of the cold pressor task
Change in Stress as Assessed by Visual Analog Scale (VAS) for Stress 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. The VAS total score ranges from 1(none) to 10(extreme stress);a higher score indicating a worse outcome. Visual Analog Scale (VAS) for stress score will be collected before and after the CPT. The change in Stress will be reported as [( Visual Analog Scale (VAS) for stress score at post cold pressor task) - (Visual Analog Scale (VAS) for stress score at pre cold pressor task)].
Measured: Day 8 baseline (about 15 minutes before cold pressor task) and about 30 minutes after the start of the cold pressor task
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start23 Aug 2021
- Primary completion22 Aug 2024
- Study completion22 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Suchting, The University of Texas Health Science Center, Houston
- Investigators
- Robert Suchting, Ph.D., Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234997
- Sponsor's protocol ID
- HSC-MS-19-0966
- Status last verified
- Sep 2025
- First submitted
- 15 Jan 2020
- Last updated
- 1 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suvorexant to Reduce Symptoms of Nicotine Use: A Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT04234997
- Acronym / sponsor ID
- HSC-MS-19-0966
- Conditions
- Smoking Cessation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 22 Aug 2024 (actual)
- Study completion
- 22 Aug 2024 (actual)
- First posted
- 21 Jan 2020 (actual)
- Results
- Posted 1 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suvorexant 20 mg | Experimental | Drug: Suvorexant 20 mg |
| Suvorexant 0mg | Placebo comparator | Drug: Suvorexant 0mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- non-treatment seeking cigarette smokers that report smoking atleast 10 cigarettes per day
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suvorexant 20 mgParticipants 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. | Drug | Suvorexant 20 mg |
| Suvorexant 0mgParticipants 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. | Drug | Suvorexant 0mg |
Primary outcome
Stress as Assessed by a Visual Analog Scale (VAS) for Stress
Time frame: Day 1
The VAS total score ranges from 1(none) to 10(extreme stress);a higher score indicating a worse outcome.
Stress as Assessed by a Visual Analog Scale (VAS) for Stress
Time frame: Day 8
The VAS total score ranges from 1(none) to 10(extreme stress);a higher score indicating a worse outcome.
Change in Stress Reactivity as Assessed by Heart Rate During the Cold Pressor Test (CPT)
Time frame: Day 1 baseline (about 15 minutes before cold pressor task) and about 2 minutes after the start of the cold pressor task
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)].
Change in Stress Reactivity as Assessed by Heart Rate During the Cold Pressor Test (CPT)
Time frame: Day 8 baseline (about 15 minutes before cold pressor task) and about 2 minutes after the start of the cold pressor task
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)].
Change in Stress Reactivity as Assessed by Cortisol During the Cold Pressor Test (CPT)
Time frame: 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
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)].
Smoking as Assessed by Latency to Self-Administration During the Smoking Relapse Assessment
Time frame: Day 1
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.
Smoking as Assessed by Number of Self-Administrated Cigarettes During the Smoking Relapse Assessment
Time frame: Day 1
The outcome measure is the number of cigarettes self-administered by each participant during the Smoking Relapse Assessment.
Change in Sleep Quality as Assessed by the Garmin Vivosmart3 Actigraphy Device
Time frame: Day 1, Day 8
Quality defined as proportion of time in deep sleep. Change in sleep quality is reported as [(Day 8 Sleep Quality ) - (Day 1 Sleep quality)]
Change in Sleep Duration as Assessed by the Garmin Vivosmart3 Actigraphy Device
Time frame: Day 1, Day 8
Duration as the total amount of time asleep. Change in sleep duration is reported as [(Day 8 Sleep Duration ) - (Day 1 Sleep Duration)]
Change in Sleep Restlessness as Assessed by the Garmin Vivosmart3 Actigraphy Device
Time frame: Day 1, Day 8
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]
Smoking as Assessed by Number of Self-Administrated Cigarettes During the Smoking Relapse Assessment
Time frame: Day 8
The outcome measure is the number of cigarettes self-administered by each participant during the Smoking Relapse Assessment.
Smoking as Assessed by Latency to Self-Administration During the Smoking Relapse Assessment
Time frame: Day 8
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.
Nicotine Craving as Assessed by the Questionnaire of Smoking Urgers (QSU-brief)
Time frame: Day 1
The Questionnaire of Smoking Urgers (QSU-brief) total score ranges from 10 to 70, higher score indicates greater nicotine craving.
Nicotine Craving as Assessed by the Questionnaire of Smoking Urgers (QSU-brief)
Time frame: Day 8
The Questionnaire of Smoking Urgers (QSU-brief) total score ranges from 10 to 70, higher score indicates greater nicotine craving.
22 secondary outcomes
Stress as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Stress Subscale
Time frame: Day 1
Stress as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Stress Subscale
Time frame: Day 8
Stress as Assessed by the Personal Stress Scale (PSS)
Time frame: Day 1
Stress as Assessed by the Personal Stress Scale (PSS)
Time frame: Day 8
Change in Stress Reactivity as Assessed by Systolic Blood Pressure During the Cold Pressor Test (CPT)
Time frame: 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 Systolic Blood Pressure During the Cold Pressor Test (CPT)
Time frame: 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 Diastolic Blood Pressure During the Cold Pressor Test (CPT)
Time frame: 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 Diastolic Blood Pressure During the Cold Pressor Test (CPT)
Time frame: Day 8 baseline (about 15 minutes before cold pressor task) and about 2 minutes after the start of the cold pressor task
Sleep Quality as Assessed by the Patient-Reported Outcomes Measurement Information System(PROMIS) Sleep Disturbance Short Form
Time frame: Day 1
Sleep Quality as Assessed by the Patient-Reported Outcomes Measurement Information System(PROMIS) Sleep Disturbance Short Form
Time frame: Day 8
Sleep Quality as Assessed by the Epworth Sleepiness Scale (ESS)
Time frame: Day 1
Sleep Quality as Assessed by the Epworth Sleepiness Scale (ESS)
Time frame: Day 8
Withdrawal Severity as Assessed by the Minnesota Nicotine Withdrawal Questionnaire (MNWQ)
Time frame: Day 1
Withdrawal Severity as Assessed by the Minnesota Nicotine Withdrawal Questionnaire (MNWQ)
Time frame: Day 8
Anxiety a Measured by the Hamilton Anxiety Rating Scale (HAM-A)
Time frame: Day 1
Anxiety a Measured by the Hamilton Anxiety Rating Scale (HAM-A)
Time frame: Day 8
Sleep Quality as Assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Day 1
Sleep Quality as Assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Day 8
Anxiety as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Anxiety Subscale
Time frame: Day 1
Anxiety as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Anxiety Subscale
Time frame: Day 8
Change in Stress as Assessed by Visual Analog Scale (VAS) for Stress During the Cold Pressor Test (CPT)
Time frame: Day 1 baseline (about 15 minutes before cold pressor task) and about 30 minutes after the start of the cold pressor task
Change in Stress as Assessed by Visual Analog Scale (VAS) for Stress During the Cold Pressor Test (CPT)
Time frame: Day 8 baseline (about 15 minutes before cold pressor task) and about 30 minutes after the start of the cold pressor task
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Suchting, Ph.D. principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Suvorexant 20 mg and Suvorexant 0mg in people with Smoking Cessation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress as Assessed by a Visual Analog Scale (VAS) for Stress (time frame: Day 1). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.