Suvorexant for Nicotine Addiction

Recruiting in Palo Alto (17 mi)

Overseen ByAmy Janes, PhD

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Mclean Hospital

Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?Tobacco smoking continues to be the primary cause of preventable mortality in the United States. Despite the availability of smoking cessation aids, the majority of those trying to quit smoking end up relapsing. Thus, there is a strong need to evaluate alternative treatment targets such as orexin antagonists, which have shown promise in preclinical models at reducing the motivational aspects of drug use.The current work will evaluate the influence of orexin antagonism on several factors impacting the motivation to smoke.

Eligibility Criteria

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.

Inclusion Criteria

I am between 18 and 50 years old.

Participant Groups

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.

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

Suvorexant is already approved in United States, Australia, Japan for the following indications:

🇺🇸 Approved in United States as Belsomra for: