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Orexin Receptor Antagonist

Suvorexant for Smoking Cessation

Phase 2
Recruiting
Led By Robert Suchting, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Non-treatment seeking cigarette smokers that report smoking at least 10 cigarettes per day
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day1,day8
Awards & highlights

Study Summary

This trial will test if suvorexant can help reduce smoking relapse risk and validate its effect on sleep metrics in people with tobacco use disorder.

Who is the study for?
This trial is for non-treatment seeking smokers who smoke at least 10 cigarettes daily. It's not for those with alcohol or significant drug use disorders, severe psychiatric or neurological conditions, suicidal thoughts, legal obligations related to substance reporting, pregnant/nursing women, non-English speakers, or anyone on medications that interact poorly with the study drugs.Check my eligibility
What is being tested?
The study tests Suvorexant's effect on smoking relapse risk factors like craving and withdrawal symptoms and its impact on sleep in tobacco users. Participants will receive either a 20 mg dose of Suvorexant or a placebo (0mg) to compare outcomes.See study design
What are the potential side effects?
Suvorexant may cause drowsiness as it is intended to help with sleep. Other potential side effects could include headaches, dizziness, dry mouth, coughing or wheezing; however specific side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I smoke at least 10 cigarettes daily and am not seeking treatment to quit.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day1,day8
This trial's timeline: 3 weeks for screening, Varies for treatment, and day1,day8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Stress Reactivity as assessed by Heart Rate During the Cold Pressor Test (CPT)
Change in Stress Reactivity as assessed by cortisol During the Cold Pressor Test (CPT)
Change in craving as assessed by a Visual Analog Scale (VAS) for Craving
+6 more
Secondary outcome measures
Change in Withdrawal Severity as Assessed by the Minnesota Nicotine Withdrawal Questionnaire (MNWQ)
Change in sleep quality as assessed by the Epworth Sleepiness Scale (ESS)
Change in sleep quality as assessed by the Patient-Reported Outcomes Measurement Information System(PROMIS) Sleep Disturbance Short Form
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Suvorexant 20 mgExperimental Treatment1 Intervention
Group II: Suvorexant 0mgPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Suvorexant
FDA approved

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,977 Total Patients Enrolled
Robert Suchting, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
The University of Texas Health Science Center at Houston
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

Why did patients apply to this trial?

Wanting to quit smoking. I have gum disease and cigs are speeding up decay.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Suvorexant to Reduce Symptoms of Nicotine Use
Robert Suchting 2021. "Suvorexant to Reduce Symptoms of Nicotine Use". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04234997.
All > Belsomra
~2 spots leftby Sep 2024
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