Suvorexant to Reduce Symptoms of Nicotine Use

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

The purpose of this study is to assess the impact of suvorexant on established measures of smoking relapse risk (craving,withdrawal, stress reactivity, latency to self-administration) and to validate the somnolent effect of suvorexant on sleep metrics in a sample of individuals with tobacco use disorder

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: Suvorexant 20 mg; Drug: Suvorexant 0mg

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Robert Suchting, MD; Phone Number: (713) 486-2521; Email: Robert.Suchting@uth.tmc.edu
• Study Contact Backup: Name: Jessica Vincent; Phone Number: (713) 486-2645; Email: Jessica.N.Vincent@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Robert Suchting, MD; Phone Number: 713-486-2521; Email: Robert.Suchting@uth.tmc.edu
      • Contact: Jessica Vincent, MD; Phone Number: (713) 486-2645; Email: Jessica.N.Vincent@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Suvorexant 20 mg	Drug: 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.
Placebo Comparator: Suvorexant 0mg	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in craving as assessed by a Visual Analog Scale (VAS) for Craving	The VAS scale ranges from 0(not at all) to 100(extreme craving);a higher score indicating a worse outcome	Day1,Day8
Change in stress as assessed by a Visual Analog Scale (VAS) for Stress	The VAS scale ranges from 0(not at all) to 10(extreme stress);a higher score indicating a worse outcome	Day1,Day8
Change in Stress Reactivity as assessed by Heart Rate During the Cold Pressor Test (CPT)		Day1,Day8
Change in Stress Reactivity as assessed by cortisol During the Cold Pressor Test (CPT)		Day1,Day8
Change in smoking as Assessed by Latency to Self-Administration during the Smoking Relapse Assessment		Day1,day8
Change in smoking as Assessed by Number of Self-Administrated Cigarettes during the Smoking Relapse Assessment		Day1,day8
Change in sleep quality as assessed by the Garmin Vivosmart3 Actigraphy Device	Quality defined as proportion of time in deep sleep	Day1,day8
Change in sleep duration as assessed by the Garmin Vivosmart3 Actigraphy Device	Duration as the total amount of time asleep	Day1,day8
Change in sleep restlessness as assessed by the Garmin Vivosmart3 Actigraphy Device	Restlessness as the number of times waking up during sleep	Day1,day8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in stress as assessed by the Depression-Anxiety-Stress 21 (DASS21) Self-Report Questionnaire - Stress Subscale	The DASS 21 is a 21 item self report questionnaire. Each item is scored from 0 (did not apply to me at all over the last week) to 3 (applied to me very much or most of the time over the past week).	Day1,day8
Change in stress as assessed by the Personal Stress Scale (PSS)	There are 10 questions ranging from a score of 0(never) to 4(very often) for a total maximum score of 40	Day1,day8
Change in stress reactivity as assessed by Systolic Blood Pressure During the Cold Pressor Test (CPT)		Day1,day8
Change in stress reactivity as assessed by Diastolic Blood Pressure During the Cold Pressor Test (CPT)		Day1,day8
Change in sleep quality as assessed by the Patient-Reported Outcomes Measurement Information System(PROMIS) Sleep Disturbance Short Form	This scale ranges form 1(very much)to 5(not at all)	Day1,day8
Change in sleep quality as assessed by the Epworth Sleepiness Scale (ESS)	This scale ranges form 0(would never dose) to 3(high chance of dosing)	Day1,day8
Change in Withdrawal Severity as Assessed by the Minnesota Nicotine Withdrawal Questionnaire (MNWQ)	This scale contains 9 questions scored between 0-4 with higher scores meaning greater withdrawal symptoms	Day1,day8

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Robert Suchting, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2021
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 21, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Hypnotics and Sedatives; Sleep Aids, Pharmaceutical; Orexin Receptor Antagonists; Suvorexant
• Other Study ID Numbers: HSC-MS-19-0966

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No