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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
14
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.
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.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
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
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
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
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
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 \[(cortisol level at post cold pressor task) - (cortisol level pre cold pressor task)\].
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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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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