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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suvorexant 20 mg | Experimental |
| |
| Suvorexant 0mg | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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)]. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Suchting, Ph.D. | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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Of the 14 enrolled participants, 11 were randomized and 3 withdrew from the study before randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Suvorexant 20 mg | 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. |
| FG001 | Suvorexant 0mg | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
include all who were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Suvorexant 20 mg | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
Up to 8 Days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Suvorexant 20 mg | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Suchting, MD | The University of Texas Health Science Center at Houston | 713-486-2521 | Robert.Suchting@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 12, 2023 | Aug 18, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C551624 | suvorexant |
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| 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. |
|
| 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 |
| 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. |
| 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. | 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. | 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)]. | 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)]. | 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)]. | 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)]. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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)]. | 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)]. | Day 8 baseline (about 15 minutes before cold pressor task) and about 30 minutes after the start of the cold pressor task |
| Suvorexant 0mg |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Years of Education | Mean | Standard Deviation | years |
|
| Nicotine dependence as assessed by the Fagerstrom Test for Nicotine Dependence | The Fagerström Test for Nicotine Dependence (FTND) is a standard instrument used to assess the intensity of physical addiction to nicotine. Total scores range from 0 to 10, with higher scores indicating greater nicotine dependence. | Mean | Standard Deviation | score on a scale |
|
| Cognitive ability as assessed by Shipley 2- Composite B | The Shipley 2- Composite B measures cognitive ability. The total score ranges from 25 to 145, higher score indicating higher cognitive ability. | Mean | Standard Deviation | score on a scale |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 8 |
|
|
|
| Primary | 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)]. | Posted | Mean | Standard Deviation | beats per minutes (bpm) | Day 1 baseline (about 15 minutes before cold pressor task) and about 2 minutes after the start of the cold pressor task |
|
|
|
| Primary | 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)]. | Posted | Mean | Standard Deviation | beats per minutes (bpm) | Day 8 baseline (about 15 minutes before cold pressor task) and about 2 minutes after the start of the cold pressor task |
|
|
|
| Primary | 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)]. | All cortisol samples were compromised during collection and storage due to cross-contamination between control and experimental samples. As a result, the samples could not be processed, and no outcome data were collected. | Posted | 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 |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | minutes | Day 1 |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | cigarettes | Day 1 |
|
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|
| Primary | 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)] | Data were not collected from 3 participants in the Suvorexant 20 mg arm and Data were not collected for 5 participants in the Suvorexant 0mg due to device malfunction and/or user error. | Posted | Mean | Standard Deviation | minutes | Day 1, Day 8 |
|
|
|
| Primary | 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)] | Data were not collected from 3 participants in the Suvorexant 20 mg arm and Data were not collected for 5 participants in the Suvorexant 0mg due to device malfunction and/or user error. | Posted | Mean | Standard Deviation | minutes | Day 1, Day 8 |
|
|
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| Primary | 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] | Data were not collected from 3 participants in the Suvorexant 20 mg arm and Data were not collected for 5 participants in the Suvorexant 0mg due to device malfunction and/or user error. | Posted | Mean | Standard Deviation | number of times awake | Day 1, Day 8 |
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| Primary | 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. | Posted | Mean | Standard Deviation | cigarettes | Day 8 |
|
|
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| Primary | 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. | Posted | Mean | Standard Deviation | minutes | Day 8 |
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 8 |
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|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 8 |
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 8 |
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| Secondary | 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)]. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Day 1 baseline (about 15 minutes before cold pressor task) and about 2 minutes after the start of the cold pressor task |
|
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| Secondary | 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)]. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Day 8 baseline (about 15 minutes before cold pressor task) and about 2 minutes after the start of the cold pressor task |
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| Secondary | 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)]. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Day 1 baseline (about 15 minutes before cold pressor task) and about 2 minutes after the start of the cold pressor task |
|
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| Secondary | 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)]. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Day 8 baseline (about 15 minutes before cold pressor task) and about 2 minutes after the start of the cold pressor task |
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 8 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 8 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 8 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 8 |
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| Secondary | 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. | Posted | Mean | Standard Error | score on a scale | Day 1 |
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| Secondary | 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. | Posted | Mean | Standard Error | score on a scale | Day 8 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 8 |
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| Secondary | 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)]. | Posted | Mean | Standard Deviation | score on a scale | Day 1 baseline (about 15 minutes before cold pressor task) and about 30 minutes after the start of the cold pressor task |
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| Secondary | 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)]. | Posted | Mean | Standard Deviation | score on a scale | Day 8 baseline (about 15 minutes before cold pressor task) and about 30 minutes after the start of the cold pressor task |
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Suvorexant 0mg | 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. | 0 | 6 | 0 | 6 | 0 | 6 |
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