Could a sleep medication curb nicotine cravings?

NCT ID NCT03999099

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This study tests whether suvorexant, a drug used for insomnia, can reduce nicotine cravings and withdrawal symptoms in daily smokers. Participants, who smoke at least 5 cigarettes a day and are nicotine-dependent, will receive either a low or high dose of suvorexant or a placebo. The goal is to see if blocking the brain chemical orexin can make it easier to resist smoking.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
suvorexant, a drug that blocks orexin, a brain chemical involved in wakefulness and craving
What this could lead to
If it works, this could point toward a new way to help people quit smoking by reducing cravings and withdrawal symptoms.
What could go wrong
This is an early-phase trial with only 45 participants, so results may not apply broadly. Suvorexant can cause drowsiness, which might limit its use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants will be male and female volunteers between the ages of 18-50 * Participants must report daily smoking of at least 5 cigarettes per day over the last 6 months. * Participants must be nicotine dependent, having an FTND score greater than or equal to 4. * Participants must have an expired carbon monoxide level of 10 ppm or more on the screening day. * Participants must have an expired carbon monoxide level of no more than 10 ppm on the study visits. * Female participants must have a negative pregnancy test on all study days. Exclusion Criteria: * Participants cannot meet DSM-5 criteria for lifetime and/or current psychotic disorders such as bipolar disorder, schizophrenia, schizoaffective disorder * Participants cannot meet DSM-5 criteria for current substance abuse disorders other than nicotine and marihuana and cannot meet criteria for current moderate or severe alcohol use disorder (as assessed by the SCID-5) * Participants cannot have positive drug and alcohol screen on each study visit other than for nicotine or marijuana. * Participants reporting marihuana use greater than 1-2 times per week will be excluded. * Participants must report no marihuana use within 24 hours of the study visit. * Participants cannot be taking any prescription medication that could impact brain function including medications that depress CNS function * Participants cannot have a history of major head trauma resulting in cognitive impairment, seizure, or other neurological disorders. * Participants cannot be pregnant or breastfeeding. * Participants must be able to read screening materials including consent form and give informed consent * Individuals with severe hepatic impairment will be excluded. * Participants cannot be obese as determined by a Body Mass Index (BMI) of 30 or greater. * Participants cannot be using a CYP3A inhibitor/inducer (metabolism by CYP3A is the major elimination pathway for suvorexant) * Participants cannot have a current cardiac disorder such as palpitations, tachycardia and/or use of the cardiac medication Digoxin * Participants cannot have narcolepsy * Participants cannot self-report complex sleep behaviors such as sleep driving, preparing and eating food or making phone calls * Participants cannot have compromised respiratory function such severe obstructive sleep apnea or severe chronic obstructive pulmonary disease * Participants cannot have current major depressive disorder (within the past 6 months) and/or indorse suicidal ideation on the Beck Depression Inventory.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • McLean Hospital

    Belmont, Massachusetts, 02478, United States

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