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Orexin Antagonist

Suvorexant 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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 4 hours post drug administration
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved

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.
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.
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 below
Select...
I am between 18 and 50 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 4 hours post drug administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4 hours post drug administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Nicotine Craving
Nicotine withdrawal
Secondary study objectives
Somnolence

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

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
216 Previous Clinical Trials
21,828 Total Patients Enrolled
Amy Janes, PhDPrincipal InvestigatorMclean Hospital
1 Previous Clinical Trials
10 Total Patients Enrolled
~0 spots leftby Dec 2024
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