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Completed

NCT Number: NCT04234997

Suvorexant to Reduce Symptoms of Nicotine Use

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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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Stress as Assessed by a Visual Analog Scale (VAS) for Stress

    Time frame: Day 1

    The VAS total score ranges from 1(none) to 10(extreme stress);a higher score indicating a worse outcome.

  2. Stress as Assessed by a Visual Analog Scale (VAS) for Stress

    Time frame: Day 8

    The VAS total score ranges from 1(none) to 10(extreme stress);a higher score indicating a worse outcome.

  3. Change in Stress Reactivity as Assessed by Heart Rate During the Cold Pressor Test (CPT)

    Time frame: Day 1 baseline (about 15 minutes before cold pressor task) and about 2 minutes after the start of the cold pressor task

    During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Heart rate will be collected pre CPT (about 15 minutes before cold pressor task) and post CPT (about 2 minutes after the start of the cold pressor task). The change in Heart rate will be reported as [(Heart rate post cold pressor task) - (Heart rate pre cold pressor task)].

  4. Change in Stress Reactivity as Assessed by Heart Rate During the Cold Pressor Test (CPT)

    Time frame: Day 8 baseline (about 15 minutes before cold pressor task) and about 2 minutes after the start of the cold pressor task

    During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Heart rate will be collected pre CPT (about 15 minutes before cold pressor task) and post CPT (about 2 minutes after the start of the cold pressor task). The change in Heart rate will be reported as [(Heart rate post cold pressor task) - (Heart rate pre cold pressor task)].

  5. Change in Stress Reactivity as Assessed by Cortisol During the Cold Pressor Test (CPT)

    Time frame: Day 1 baseline (about 15 minutes before cold pressor task) and about 30 minutes after the start of the cold pressor task, Day 8 baseline (about 15 minutes before cold pressor task) and about 30 minutes after the start of the cold pressor task

    During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Saliva samples will be collected pre CPT (about 15 minutes before cold pressor task) and post CPT (about 30 minutes after the start of the cold pressor task), and cortisol levels in the saliva samples will be assessed. The change in cortisol level will be reported as [(cortisol level at post cold pressor task) - (cortisol level pre cold pressor task)].

  6. Smoking as Assessed by Latency to Self-Administration During the Smoking Relapse Assessment

    Time frame: Day 1

    Latency to self-administration is defined as the time (in minutes) from the beginning of the relapse assessment session until the participant initiates smoking their first cigarette.

  7. Smoking as Assessed by Number of Self-Administrated Cigarettes During the Smoking Relapse Assessment

    Time frame: Day 1

    The outcome measure is the number of cigarettes self-administered by each participant during the Smoking Relapse Assessment.

  8. Change in Sleep Quality as Assessed by the Garmin Vivosmart3 Actigraphy Device

    Time frame: Day 1, Day 8

    Quality defined as proportion of time in deep sleep. Change in sleep quality is reported as [(Day 8 Sleep Quality ) - (Day 1 Sleep quality)]

  9. Change in Sleep Duration as Assessed by the Garmin Vivosmart3 Actigraphy Device

    Time frame: Day 1, Day 8

    Duration as the total amount of time asleep. Change in sleep duration is reported as [(Day 8 Sleep Duration ) - (Day 1 Sleep Duration)]

  10. Change in Sleep Restlessness as Assessed by the Garmin Vivosmart3 Actigraphy Device

    Time frame: Day 1, Day 8

    Restlessness as the number of times waking up during sleep. Change in sleep restlessness is reported as [(Day 8 Sleep restlessness) - (Day 1 Sleep restlessness]

  11. Smoking as Assessed by Number of Self-Administrated Cigarettes During the Smoking Relapse Assessment

    Time frame: Day 8

    The outcome measure is the number of cigarettes self-administered by each participant during the Smoking Relapse Assessment.

  12. Smoking as Assessed by Latency to Self-Administration During the Smoking Relapse Assessment

    Time frame: Day 8

    Latency to self-administration is defined as the time (in minutes) from the beginning of the relapse assessment session until the participant initiates smoking their first cigarette.

  13. Nicotine Craving as Assessed by the Questionnaire of Smoking Urgers (QSU-brief)

    Time frame: Day 1

    The Questionnaire of Smoking Urgers (QSU-brief) total score ranges from 10 to 70, higher score indicates greater nicotine craving.

  14. Nicotine Craving as Assessed by the Questionnaire of Smoking Urgers (QSU-brief)

    Time frame: Day 8

    The Questionnaire of Smoking Urgers (QSU-brief) total score ranges from 10 to 70, higher score indicates greater nicotine craving.

Secondary outcomes

  1. Stress as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Stress Subscale

    Time frame: 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.

  2. Stress as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Stress Subscale

    Time frame: Day 8

    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.

  3. Stress as Assessed by the Personal Stress Scale (PSS)

    Time frame: Day 1

    The Personal Stress Scale (PSS) total score ranges from 0 to 40, a higher score indicating greater stress.

  4. Stress as Assessed by the Personal Stress Scale (PSS)

    Time frame: Day 8

    The Personal Stress Scale (PSS) total score ranges from 0 to 40, a higher score indicating greater stress.

  5. Change in Stress Reactivity as Assessed by Systolic Blood Pressure During the Cold Pressor Test (CPT)

    Time frame: Day 1 baseline (about 15 minutes before cold pressor task) and about 2 minutes after the start of the cold pressor task

    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)].

  6. Change in Stress Reactivity as Assessed by Systolic Blood Pressure During the Cold Pressor Test (CPT)

    Time frame: Day 8 baseline (about 15 minutes before cold pressor task) and about 2 minutes after the start of the cold pressor task

    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)].

  7. Change in Stress Reactivity as Assessed by Diastolic Blood Pressure During the Cold Pressor Test (CPT)

    Time frame: Day 1 baseline (about 15 minutes before cold pressor task) and about 2 minutes after the start of the cold pressor task

    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)].

  8. Change in Stress Reactivity as Assessed by Diastolic Blood Pressure During the Cold Pressor Test (CPT)

    Time frame: Day 8 baseline (about 15 minutes before cold pressor task) and about 2 minutes after the start of the cold pressor task

    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)].

  9. Sleep Quality as Assessed by the Patient-Reported Outcomes Measurement Information System(PROMIS) Sleep Disturbance Short Form

    Time frame: 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.

  10. Sleep Quality as Assessed by the Patient-Reported Outcomes Measurement Information System(PROMIS) Sleep Disturbance Short Form

    Time frame: Day 8

    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.

  11. Sleep Quality as Assessed by the Epworth Sleepiness Scale (ESS)

    Time frame: Day 1

    The Epworth Sleepiness Scale (ESS) total score ranges from 0 to 24, a higher score indicating worse sleep quality.

  12. Sleep Quality as Assessed by the Epworth Sleepiness Scale (ESS)

    Time frame: Day 8

    The Epworth Sleepiness Scale (ESS) total score ranges from 0 to 24, a higher score indicating worse sleep quality.

  13. Withdrawal Severity as Assessed by the Minnesota Nicotine Withdrawal Questionnaire (MNWQ)

    Time frame: Day 1

    The Minnesota Nicotine Withdrawal Questionnaire (MNWQ) total score ranges from 0 to 36 with higher scores indicating greater withdrawal symptoms.

  14. Withdrawal Severity as Assessed by the Minnesota Nicotine Withdrawal Questionnaire (MNWQ)

    Time frame: Day 8

    The Minnesota Nicotine Withdrawal Questionnaire (MNWQ) total score ranges from 0 to 36 with higher scores indicating greater withdrawal symptoms.

  15. Anxiety a Measured by the Hamilton Anxiety Rating Scale (HAM-A)

    Time frame: Day 1

    The Hamilton Anxiety Rating Scale (HAM-A) total score ranges from 0 to 56, a higher score indicating greater anxiety.

  16. Anxiety a Measured by the Hamilton Anxiety Rating Scale (HAM-A)

    Time frame: Day 8

    The Hamilton Anxiety Rating Scale (HAM-A) total score ranges from 0 to 56, a higher score indicating greater anxiety.

  17. Sleep Quality as Assessed by the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Day 1

    The Pittsburgh Sleep Quality Index (PSQI) total score ranges from 0 to 21, a higher score indicates worse sleep quality.

  18. Sleep Quality as Assessed by the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Day 8

    The Pittsburgh Sleep Quality Index (PSQI) total score ranges from 0 to 21, a higher score indicates worse sleep quality.

  19. Anxiety as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Anxiety Subscale

    Time frame: 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.

  20. Anxiety as Assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Anxiety Subscale

    Time frame: Day 8

    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.

  21. Change in Stress as Assessed by Visual Analog Scale (VAS) for Stress During the Cold Pressor Test (CPT)

    Time frame: Day 1 baseline (about 15 minutes before cold pressor task) and about 30 minutes after the start of the cold pressor task

    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)].

  22. Change in Stress as Assessed by Visual Analog Scale (VAS) for Stress During the Cold Pressor Test (CPT)

    Time frame: Day 8 baseline (about 15 minutes before cold pressor task) and about 30 minutes after the start of the cold pressor task

    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)].

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Suvorexant to Reduce Symptoms of Nicotine Use: A Double-blind, Placebo-controlled Study

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 21, 2020
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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