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Orexin Antagonist
Suvorexant 20 mg for Nicotine Addiction
Phase 1
Recruiting
Led By Amy Janes, PhD
Research Sponsored by Mclean Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants will be male and female volunteers between the ages of 18-50
Female participants must have a negative pregnancy test on all study days.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 4 hours post drug administration
Awards & highlights
Study Summary
This trial will investigate how a type of medication called orexin antagonists can help people quit smoking. Smoking is a major cause of preventable deaths in the US, but many people struggle to quit and
Who is the study for?
This trial is for male and female smokers aged 18-50 who smoke at least 5 cigarettes daily for the past 6 months, are nicotine dependent with an FTND score of 4 or more, and have certain carbon monoxide levels in their breath. Women must not be pregnant.Check my eligibility
What is being tested?
The study tests Suvorexant (at doses of either 20 mg or 10 mg) against a placebo to see if it can reduce the desire to smoke by blocking orexin, which may influence motivation related to drug use.See study design
What are the potential side effects?
Possible side effects of Suvorexant include sleepiness during the day, dizziness, abnormal dreams, headaches, and potentially others that will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 50 years old.
Select...
I am not pregnant, as confirmed by tests on all study days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 4 hours post drug administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 4 hours post drug administration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Nicotine Craving
Nicotine withdrawal
Secondary outcome measures
Somnolence
Side effects data
From 2018 Phase 4 trial • 12 Patients • NCT033125178%
Dry Mouth
8%
Upset
8%
Tingling sensation in arm
8%
Dizziness
8%
Anxiety
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Belsomra 20mg
Belsomra 10mg
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Suvorexant 20mgExperimental Treatment1 Intervention
Suvorexant 20mg oral dose
Group II: Suvorexant 10mgExperimental Treatment1 Intervention
Suvorexant 10mg oral dose
Group III: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Suvorexant
FDA approved
Suvorexant
FDA approved
Find a Location
Who is running the clinical trial?
Mclean HospitalLead Sponsor
212 Previous Clinical Trials
21,576 Total Patients Enrolled
Amy Janes, PhDPrincipal InvestigatorMclean Hospital
1 Previous Clinical Trials
10 Total Patients Enrolled
Frequently Asked Questions
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