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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
Must not have
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)
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day1,day8
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved

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.
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.
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
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I smoke at least 10 cigarettes daily and am not seeking treatment to quit.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not on medications that badly interact with the study drugs.
Select...
I do not have severe lung, heart, liver, kidney diseases, abnormal EEG, seizures, or sleep disorders like narcolepsy.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in craving as assessed by a Visual Analog Scale (VAS) for Craving
Change in sleep duration as assessed by the Garmin Vivosmart3 Actigraphy Device
Change in sleep quality as assessed by the Garmin Vivosmart3 Actigraphy Device
+2 more
Secondary study objectives
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
+2 more

Side effects data

From 2018 Phase 4 trial • 12 Patients • NCT03312517
8%
Dizziness
8%
Upset
8%
Anxiety
8%
Dry Mouth
8%
Tingling sensation in arm
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Belsomra 20mg
Belsomra 10mg

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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
949 Previous Clinical Trials
345,005 Total Patients Enrolled
Robert Suchting, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
~5 spots leftby Nov 2025
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