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Suvorexant for Nicotine Addiction

AJ
NK
Overseen ByNathan Krantz, BA
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help people quit smoking by testing Suvorexant, a sleep aid drug that affects the brain's motivation signals. Researchers aim to determine if this drug can reduce the urge to smoke. Participants will receive either Suvorexant at varying doses or a placebo, which is a harmless pill resembling the real drug. Individuals who have smoked at least 5 cigarettes daily for the past 6 months and are nicotine dependent may be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription medications that could affect brain function, including those that depress the central nervous system. Also, you cannot use medications that affect the CYP3A enzyme, which is important for processing the trial drug.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that suvorexant, a treatment being tested for nicotine addiction, has been used to treat conditions like insomnia. In studies with individuals experiencing opioid withdrawal, those who took suvorexant reported feeling less stressed than those who received a placebo. This suggests it might help with withdrawal symptoms.

The trial is in its early stages, primarily to assess if the treatment is safe and well-tolerated. Suvorexant's use for other conditions provides some insight into its safety. The FDA has already approved suvorexant for treating insomnia, indicating it has passed certain safety checks for that purpose. However, its safety for treating nicotine addiction remains under investigation.12345

Why do researchers think this study treatment might be promising for nicotine addiction?

Most treatments for nicotine addiction rely on nicotine replacement therapies or medications like varenicline and bupropion. But suvorexant works differently by targeting the brain's orexin system, which is involved in wakefulness and cravings. This unique mechanism could help reduce nicotine cravings more effectively. Researchers are excited because suvorexant may offer a new approach, potentially improving success rates for quitting smoking compared to current options.

What evidence suggests that Suvorexant might be an effective treatment for nicotine addiction?

Research has shown that suvorexant, a type of medication, might help reduce cravings and withdrawal symptoms for those trying to quit smoking. In studies on opioid withdrawal, participants taking suvorexant experienced less stress compared to those on a placebo. It also appears to alleviate sleep problems, which are common when quitting smoking. This trial will test different doses of suvorexant, including 10mg and 20mg, against a placebo to evaluate its effectiveness specifically for smoking cessation. Although these early results are encouraging, further research is needed to confirm its efficacy in this context.14678

Who Is on the Research Team?

AJ

Amy Janes, PhD

Principal Investigator

Mclean Hospital

Are You a Good Fit for This Trial?

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

Your carbon monoxide level must be at least 10 parts per million on the day of screening.
I am not pregnant, as confirmed by tests on all study days.
Your carbon monoxide level must be no higher than 10 parts per million during the study visits.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Suvorexant 20mg, Suvorexant 10mg, or placebo to evaluate the influence of orexin antagonism on nicotine dependence

4 weeks
Weekly visits for drug administration and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Suvorexant

Trial Overview

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.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: Suvorexant 20mgExperimental Treatment1 Intervention
Group II: Suvorexant 10mgExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

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

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Approved in United States as Belsomra for:
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Approved in Japan as Belsomra for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mclean Hospital

Lead Sponsor

Trials
221
Recruited
22,500+

Citations

Belsomra + Methylphenidate for Smoking Cessation

In studies, participants taking suvorexant during opioid withdrawal reported feeling less stressed than those who took a placebo.

New medications development for smoking cessation

approximately 80% of smokers will relapse within the first month of a quit attempt. Suvorexant ameliorated sleep disturbance, opioid withdrawal, and craving ...

Comparative assessment of outcomes of smoking cessation ...

In the long-term, the quit rates were 19.6, 22.5, 25.9, and 21.7%, respectively (p=0.405). About 9% of the patients failed to quit smoking ...

success-rates-of-pharmacological-therapies-used-for- ...

Quitting smoking is beneficial to health at any age, and cigarette smokers who quit before age 35 years have similar mortality rates to those who never smoked ( ...

Dual Orexin Receptor Antagonists (DORAs) as an Adjunct ...

DORA agents suvorexant and lemborexant may accomplish this by diminishing withdrawal difficulty and reducing nicotine cravings.

Suvorexant to Reduce Symptoms of Nicotine Use

The purpose of this study is to assess the impact of suvorexant on established measures of smoking relapse risk (craving,withdrawal, stress reactivity, latency ...

New medications development for smoking cessation - PMC

approximately 80% of smokers will relapse within the first month of a quit attempt … negative perceptions about the safety and efficacy of these medications ...

Adult Smoking Cessation — United States, 2022 | MMWR

Quitting smoking reduces the risk for premature death and smoking-related diseases (1). Tobacco dependence is a chronic, relapsing condition ...