Smoking Cessation
Conditions
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
Interventions
DRUGSuvorexant 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.
DRUGSuvorexant 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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stress as Assessed by a Visual Analog Scale (VAS) for Stress | Day 1 | 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) | 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 Cortisol During the Cold Pressor Test (CPT) | 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 | 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 | 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 | 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 | 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 | Day 1, Day 8 | Restlessness as the number of times waking up during sleep. Change in sleep restlessness is reported as \[(Day 8 Sleep restlessness) - (Day 1 Sleep restlessness\] |
| Nicotine Craving as Assessed by the Questionnaire of Smoking Urgers (QSU-brief) | Day 1 | The Questionnaire of Smoking Urgers (QSU-brief) total score ranges from 10 to 70, higher score indicates greater nicotine craving. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Anxiety Subscale | Day 1 | 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. |
| Stress as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Stress Subscale | Day 1 | 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. |
| Change in Stress as Assessed by Visual Analog Scale (VAS) for Stress During the Cold Pressor Test (CPT) | Day 1 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. 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 \[( Visual Analog Scale (VAS) for stress score at post cold pressor task) - (Visual Analog Scale (VAS) for stress score at pre cold pressor task)\]. |
| Stress as Assessed by the Personal Stress Scale (PSS) | Day 1 | The Personal Stress Scale (PSS) total score ranges from 0 to 40, a higher score indicating greater stress. |
| Change in Stress Reactivity as Assessed by Systolic Blood Pressure During the Cold Pressor Test (CPT) | 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. 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 \[( Systolic Blood Pressure at post cold pressor task) - (Systolic Blood Pressure at pre cold pressor task)\]. |
| Change in Stress Reactivity as Assessed by Diastolic Blood Pressure During the Cold Pressor Test (CPT) | 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. 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 \[( Diastolic Blood Pressure at post cold pressor task) - (Diastolic Blood Pressure at pre cold pressor task)\]. |
| Sleep Quality as Assessed by the Patient-Reported Outcomes Measurement Information System(PROMIS) Sleep Disturbance Short Form | Day 1 | 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. |
| Sleep Quality as Assessed by the Epworth Sleepiness Scale (ESS) | Day 1 | The Epworth Sleepiness Scale (ESS) total score ranges from 0 to 24, a higher score indicating worse sleep quality. |
| Withdrawal Severity as Assessed by the Minnesota Nicotine Withdrawal Questionnaire (MNWQ) | Day 1 | The Minnesota Nicotine Withdrawal Questionnaire (MNWQ) total score ranges from 0 to 36 with higher scores indicating greater withdrawal symptoms. |
| Anxiety a Measured by the Hamilton Anxiety Rating Scale (HAM-A) | Day 1 | The Hamilton Anxiety Rating Scale (HAM-A) total score ranges from 0 to 56, a higher score indicating greater anxiety. |
| Sleep Quality as Assessed by the Pittsburgh Sleep Quality Index (PSQI) | Day 1 | The Pittsburgh Sleep Quality Index (PSQI) total score ranges from 0 to 21, a higher score indicates worse sleep quality. |
Countries
United States
Participant flow
Pre-assignment details
Of the 14 enrolled participants, 11 were randomized and 3 withdrew from the study before randomization.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| 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. | 6 |
| Total | 11 |
Baseline characteristics
| Characteristic | Suvorexant 20 mg | Suvorexant 0mg | Total |
|---|---|---|---|
| Age, Continuous | 52.60 years STANDARD_DEVIATION 7.92 | 46.67 years STANDARD_DEVIATION 7.15 | 49.36 years STANDARD_DEVIATION 7.76 |
| Cognitive ability as assessed by Shipley 2- Composite B | 91.00 score on a scale STANDARD_DEVIATION 14.07 | 98.00 score on a scale STANDARD_DEVIATION 10.83 | 94.82 score on a scale STANDARD_DEVIATION 12.29 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Nicotine dependence as assessed by the Fagerstrom Test for Nicotine Dependence | 5.80 score on a scale STANDARD_DEVIATION 1.64 | 6.17 score on a scale STANDARD_DEVIATION 1.94 | 6.00 score on a scale STANDARD_DEVIATION 1.73 |
| Race/Ethnicity, Customized African-American | 3 Participants | 4 Participants | 7 Participants |
| Race/Ethnicity, Customized Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 2 Participants | 1 Participants | 3 Participants |
| Region of Enrollment United States | 5 participants | 6 participants | 11 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
| Years of Education | 12.20 years STANDARD_DEVIATION 0.45 | 12.83 years STANDARD_DEVIATION 1.83 | 12.55 years STANDARD_DEVIATION 1.37 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 6 |
| other Total, other adverse events | 0 / 5 | 0 / 6 |
| serious Total, serious adverse events | 0 / 5 | 0 / 6 |
Outcome results
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 \[(Day 8 Sleep Duration ) - (Day 1 Sleep Duration)\]
Time frame: Day 1, Day 8
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Change in Sleep Duration as Assessed by the Garmin Vivosmart3 Actigraphy Device | -195.5 minutes | Standard Deviation 229.8 |
| Suvorexant 0mg | Change in Sleep Duration as Assessed by the Garmin Vivosmart3 Actigraphy Device | 79 minutes | — |
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 \[(Day 8 Sleep Quality ) - (Day 1 Sleep quality)\]
Time frame: Day 1, Day 8
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Change in Sleep Quality as Assessed by the Garmin Vivosmart3 Actigraphy Device | -0.038 minutes | Standard Deviation 0.1 |
| Suvorexant 0mg | Change in Sleep Quality as Assessed by the Garmin Vivosmart3 Actigraphy Device | 0.4 minutes | — |
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 \[(Day 8 Sleep restlessness) - (Day 1 Sleep restlessness\]
Time frame: Day 1, Day 8
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Change in Sleep Restlessness as Assessed by the Garmin Vivosmart3 Actigraphy Device | 0.5 number of times awake | Standard Deviation 0.707 |
| Suvorexant 0mg | Change in Sleep Restlessness as Assessed by the Garmin Vivosmart3 Actigraphy Device | 7 number of times awake | — |
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 \[(cortisol level at post cold pressor task) - (cortisol level pre cold pressor task)\].
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
Population: 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.
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 \[(Heart rate post cold pressor task) - (Heart rate pre cold pressor task)\].
Time frame: Day 1 baseline (about 15 minutes before cold pressor task) and about 2 minutes after the start of the cold pressor task
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Change in Stress Reactivity as Assessed by Heart Rate During the Cold Pressor Test (CPT) | 5 beats per minutes (bpm) | Standard Deviation 1.581 |
| Suvorexant 0mg | Change in Stress Reactivity as Assessed by Heart Rate During the Cold Pressor Test (CPT) | 9.5 beats per minutes (bpm) | Standard Deviation 3.728 |
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 \[(Heart rate post cold pressor task) - (Heart rate pre cold pressor task)\].
Time frame: Day 8 baseline (about 15 minutes before cold pressor task) and about 2 minutes after the start of the cold pressor task
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Change in Stress Reactivity as Assessed by Heart Rate During the Cold Pressor Test (CPT) | 3.667 beats per minutes (bpm) | Standard Deviation 1.528 |
| Suvorexant 0mg | Change in Stress Reactivity as Assessed by Heart Rate During the Cold Pressor Test (CPT) | 9 beats per minutes (bpm) | Standard Deviation 4.183 |
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Nicotine Craving as Assessed by the Questionnaire of Smoking Urgers (QSU-brief) | 45.8 score on a scale | Standard Deviation 12.24 |
| Suvorexant 0mg | Nicotine Craving as Assessed by the Questionnaire of Smoking Urgers (QSU-brief) | 36.67 score on a scale | Standard Deviation 14.92 |
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.
Time frame: Day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Nicotine Craving as Assessed by the Questionnaire of Smoking Urgers (QSU-brief) | 47.67 score on a scale | Standard Deviation 17.21 |
| Suvorexant 0mg | Nicotine Craving as Assessed by the Questionnaire of Smoking Urgers (QSU-brief) | 39.8 score on a scale | Standard Deviation 11.17 |
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.
Time frame: Day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Smoking as Assessed by Latency to Self-Administration During the Smoking Relapse Assessment | 56.67 minutes | Standard Deviation 5.77 |
| Suvorexant 0mg | Smoking as Assessed by Latency to Self-Administration During the Smoking Relapse Assessment | 16.2 minutes | Standard Deviation 22.02 |
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Smoking as Assessed by Latency to Self-Administration During the Smoking Relapse Assessment | 56.8 minutes | Standard Deviation 4.44 |
| Suvorexant 0mg | Smoking as Assessed by Latency to Self-Administration During the Smoking Relapse Assessment | 22.67 minutes | Standard Deviation 22.99 |
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Smoking as Assessed by Number of Self-Administrated Cigarettes During the Smoking Relapse Assessment | 0.8 cigarettes | Standard Deviation 1.3 |
| Suvorexant 0mg | Smoking as Assessed by Number of Self-Administrated Cigarettes During the Smoking Relapse Assessment | 1.33 cigarettes | Standard Deviation 0.52 |
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.
Time frame: Day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Smoking as Assessed by Number of Self-Administrated Cigarettes During the Smoking Relapse Assessment | 1.33 cigarettes | Standard Deviation 2.31 |
| Suvorexant 0mg | Smoking as Assessed by Number of Self-Administrated Cigarettes During the Smoking Relapse Assessment | 1.4 cigarettes | Standard Deviation 0.55 |
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.
Time frame: Day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Stress as Assessed by a Visual Analog Scale (VAS) for Stress | 3.33 score on a scale | Standard Deviation 2.89 |
| Suvorexant 0mg | Stress as Assessed by a Visual Analog Scale (VAS) for Stress | 3.2 score on a scale | Standard Deviation 2.39 |
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Stress as Assessed by a Visual Analog Scale (VAS) for Stress | 3.4 score on a scale | Standard Deviation 2.07 |
| Suvorexant 0mg | Stress as Assessed by a Visual Analog Scale (VAS) for Stress | 3 score on a scale | Standard Deviation 2.61 |
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.
Time frame: Day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Anxiety a Measured by the Hamilton Anxiety Rating Scale (HAM-A) | 2.33 score on a scale | Standard Deviation 3.21 |
| Suvorexant 0mg | Anxiety a Measured by the Hamilton Anxiety Rating Scale (HAM-A) | 3 score on a scale | Standard Deviation 1.22 |
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Anxiety a Measured by the Hamilton Anxiety Rating Scale (HAM-A) | 2.8 score on a scale | Standard Deviation 2.05 |
| Suvorexant 0mg | Anxiety a Measured by the Hamilton Anxiety Rating Scale (HAM-A) | 3.17 score on a scale | Standard Deviation 1.47 |
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Anxiety as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Anxiety Subscale | 0.8 score on a scale | Standard Deviation 1.3 |
| Suvorexant 0mg | Anxiety as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Anxiety Subscale | 2.5 score on a scale | Standard Deviation 2.17 |
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.
Time frame: Day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Anxiety as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Anxiety Subscale | 0.67 score on a scale | Standard Deviation 0.58 |
| Suvorexant 0mg | Anxiety as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Anxiety Subscale | 3 score on a scale | Standard Deviation 3 |
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 \[( Visual Analog Scale (VAS) for stress score at post cold pressor task) - (Visual Analog Scale (VAS) for stress score at pre cold pressor task)\].
Time frame: Day 8 baseline (about 15 minutes before cold pressor task) and about 30 minutes after the start of the cold pressor task
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Change in Stress as Assessed by Visual Analog Scale (VAS) for Stress During the Cold Pressor Test (CPT) | 1 score on a scale | Standard Deviation 1 |
| Suvorexant 0mg | Change in Stress as Assessed by Visual Analog Scale (VAS) for Stress During the Cold Pressor Test (CPT) | -0.2 score on a scale | Standard Deviation 0.447 |
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 \[( Visual Analog Scale (VAS) for stress score at post cold pressor task) - (Visual Analog Scale (VAS) for stress score at pre cold pressor task)\].
Time frame: Day 1 baseline (about 15 minutes before cold pressor task) and about 30 minutes after the start of the cold pressor task
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Change in Stress as Assessed by Visual Analog Scale (VAS) for Stress During the Cold Pressor Test (CPT) | 0 score on a scale | Standard Deviation 0.707 |
| Suvorexant 0mg | Change in Stress as Assessed by Visual Analog Scale (VAS) for Stress During the Cold Pressor Test (CPT) | 0 score on a scale | Standard Deviation 0 |
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 \[( Diastolic Blood Pressure at post cold pressor task) - (Diastolic Blood Pressure at pre cold pressor task)\].
Time frame: Day 1 baseline (about 15 minutes before cold pressor task) and about 2 minutes after the start of the cold pressor task
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Change in Stress Reactivity as Assessed by Diastolic Blood Pressure During the Cold Pressor Test (CPT) | 7.4 millimeters of mercury (mmHg) | Standard Deviation 9.449 |
| Suvorexant 0mg | Change in Stress Reactivity as Assessed by Diastolic Blood Pressure During the Cold Pressor Test (CPT) | 22.667 millimeters of mercury (mmHg) | Standard Deviation 8.165 |
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 \[( Diastolic Blood Pressure at post cold pressor task) - (Diastolic Blood Pressure at pre cold pressor task)\].
Time frame: Day 8 baseline (about 15 minutes before cold pressor task) and about 2 minutes after the start of the cold pressor task
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Change in Stress Reactivity as Assessed by Diastolic Blood Pressure During the Cold Pressor Test (CPT) | 9.667 millimeters of mercury (mmHg) | Standard Deviation 3.512 |
| Suvorexant 0mg | Change in Stress Reactivity as Assessed by Diastolic Blood Pressure During the Cold Pressor Test (CPT) | 14.8 millimeters of mercury (mmHg) | Standard Deviation 4.382 |
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 \[( Systolic Blood Pressure at post cold pressor task) - (Systolic Blood Pressure at pre cold pressor task)\].
Time frame: Day 1 baseline (about 15 minutes before cold pressor task) and about 2 minutes after the start of the cold pressor task
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Change in Stress Reactivity as Assessed by Systolic Blood Pressure During the Cold Pressor Test (CPT) | 17.6 millimeters of mercury (mmHg) | Standard Deviation 18.94 |
| Suvorexant 0mg | Change in Stress Reactivity as Assessed by Systolic Blood Pressure During the Cold Pressor Test (CPT) | 27.833 millimeters of mercury (mmHg) | Standard Deviation 10.572 |
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 \[( Systolic Blood Pressure at post cold pressor task) - (Systolic Blood Pressure at pre cold pressor task)\].
Time frame: Day 8 baseline (about 15 minutes before cold pressor task) and about 2 minutes after the start of the cold pressor task
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Change in Stress Reactivity as Assessed by Systolic Blood Pressure During the Cold Pressor Test (CPT) | 18 millimeters of mercury (mmHg) | Standard Deviation 11.358 |
| Suvorexant 0mg | Change in Stress Reactivity as Assessed by Systolic Blood Pressure During the Cold Pressor Test (CPT) | 16 millimeters of mercury (mmHg) | Standard Deviation 8.276 |
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.
Time frame: Day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Sleep Quality as Assessed by the Epworth Sleepiness Scale (ESS) | 12.67 score on a scale | Standard Deviation 8.62 |
| Suvorexant 0mg | Sleep Quality as Assessed by the Epworth Sleepiness Scale (ESS) | 11 score on a scale | Standard Deviation 6.04 |
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Sleep Quality as Assessed by the Epworth Sleepiness Scale (ESS) | 9.8 score on a scale | Standard Deviation 6.61 |
| Suvorexant 0mg | Sleep Quality as Assessed by the Epworth Sleepiness Scale (ESS) | 7.67 score on a scale | Standard Deviation 5.35 |
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Sleep Quality as Assessed by the Patient-Reported Outcomes Measurement Information System(PROMIS) Sleep Disturbance Short Form | 16.4 score on a scale | Standard Deviation 6.07 |
| Suvorexant 0mg | Sleep Quality as Assessed by the Patient-Reported Outcomes Measurement Information System(PROMIS) Sleep Disturbance Short Form | 18.83 score on a scale | Standard Deviation 8.89 |
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.
Time frame: Day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Sleep Quality as Assessed by the Patient-Reported Outcomes Measurement Information System(PROMIS) Sleep Disturbance Short Form | 16 score on a scale | Standard Deviation 5.2 |
| Suvorexant 0mg | Sleep Quality as Assessed by the Patient-Reported Outcomes Measurement Information System(PROMIS) Sleep Disturbance Short Form | 21.4 score on a scale | Standard Deviation 10.76 |
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Sleep Quality as Assessed by the Pittsburgh Sleep Quality Index (PSQI) | 8 score on a scale | Standard Error 2.55 |
| Suvorexant 0mg | Sleep Quality as Assessed by the Pittsburgh Sleep Quality Index (PSQI) | 8.67 score on a scale | Standard Error 5.54 |
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.
Time frame: Day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Sleep Quality as Assessed by the Pittsburgh Sleep Quality Index (PSQI) | 7 score on a scale | Standard Error 2 |
| Suvorexant 0mg | Sleep Quality as Assessed by the Pittsburgh Sleep Quality Index (PSQI) | 9.8 score on a scale | Standard Error 4.44 |
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Stress as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Stress Subscale | 0.8 score on a scale | Standard Deviation 0.84 |
| Suvorexant 0mg | Stress as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Stress Subscale | 3.5 score on a scale | Standard Deviation 2.74 |
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.
Time frame: Day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Stress as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Stress Subscale | 1.33 score on a scale | Standard Deviation 1.15 |
| Suvorexant 0mg | Stress as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Stress Subscale | 5.2 score on a scale | Standard Deviation 4.15 |
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.
Time frame: Day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Stress as Assessed by the Personal Stress Scale (PSS) | 18 score on a scale | Standard Deviation 6.24 |
| Suvorexant 0mg | Stress as Assessed by the Personal Stress Scale (PSS) | 17.4 score on a scale | Standard Deviation 2.88 |
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Stress as Assessed by the Personal Stress Scale (PSS) | 17.2 score on a scale | Standard Deviation 4.15 |
| Suvorexant 0mg | Stress as Assessed by the Personal Stress Scale (PSS) | 19 score on a scale | Standard Deviation 2.61 |
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.
Time frame: Day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Withdrawal Severity as Assessed by the Minnesota Nicotine Withdrawal Questionnaire (MNWQ) | 7 score on a scale | Standard Deviation 5.29 |
| Suvorexant 0mg | Withdrawal Severity as Assessed by the Minnesota Nicotine Withdrawal Questionnaire (MNWQ) | 11.6 score on a scale | Standard Deviation 7.02 |
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suvorexant 20 mg | Withdrawal Severity as Assessed by the Minnesota Nicotine Withdrawal Questionnaire (MNWQ) | 9.6 score on a scale | Standard Deviation 7.8 |
| Suvorexant 0mg | Withdrawal Severity as Assessed by the Minnesota Nicotine Withdrawal Questionnaire (MNWQ) | 6.67 score on a scale | Standard Deviation 3.93 |