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Sleep drug could rewire brain to fight nicotine addiction

NCT ID NCT05630781

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
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Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
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 Results may not be published yet.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.
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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

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Status unknown
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First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 15 times

Summary

This study tests whether suvorexant, a drug approved for insomnia, can reduce cravings and brain responses linked to smoking in daily smokers. Researchers will also study how it affects thinking and reward processing in non-smokers. The goal is to understand if blocking a brain chemical called orexin can help prevent relapse in nicotine addiction.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 140 people

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

Started

Feb 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: In order to be eligible to participate in this study, an individual must meet all of the following criteria: All Participants * Participants will be volunteers between the ages of 18-60 at the time of enrollment in the study (both sexes). Justification: Many neural processes change with age, and these changes could introduce unwanted variability in both behavioral and MRI signals. * Able and willing to provide written informed consent, which includes agreement to all Lifestyle Considerations at the time of study consent. Nicotine Dependence Arm -Participants must smoke/vape a minimum of 4 times per week with a urine cotinine level corresponding to nicotine user status for the specific test being used (typically corresponding to a urine cotinine above about 200 ng/ml) and have been smoking or vaping consistently for at least the past year (excluding quit attempts). EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: All Participants * 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 use disorders other than nicotine and marijuana and cannot meet criteria for current moderate or severe alcohol use disorder. * Participants cannot have positive illicit drug and alcohol screen on each study visit other than for nicotine or marijuana. * Medications with the potential to depress CNS function will be assessed by the MAI, PI, or a physician's assistant and participants excluded as necessary. * Participants cannot have a history of major head trauma resulting in cognitive impairment, seizure, or other neurological disorders. * Participant cannot have any history of neurological disorders, including seizures, epilepsy, or cognitive impairment which may impact MRI metrics. * Participants cannot be pregnant or breastfeeding. Justification: The impact of suvorexant on the developing fetus and infant. * Individuals with severe hepatic impairment will be excluded * Participants cannot be obese as determined by a Body Mass Index (BMI) of greater than 35. * Participants cannot be using a strong CYP3A inhibitor/inducer (metabolism by CYP3A is the major elimination pathway for suvorexant) * Participants cannot have any past or present significant cardiac disorders or cerebrovascular conditions such as palpitations, tachycardia, use of the cardiac medication Digoxin, arrhythmias, acute coronary syndrome, ischemic heart disease, or uncontrolled hypertension. * Participants cannot have narcolepsy. * Participants cannot self-report complex sleep behaviors such as sleep driving, preparing and eating food or making phone calls. * Participants with Major Depressive Disorder who are using medication must be stable on medication for 3 months. * Subjects with suicidal ideation where outpatient treatment is determined unsafe. * Subjects that cannot speak English. Justification: To include non-English speakers, we would have to translate the consent and other study documents and hire and train bilingual staff, which would require resources that we do not have and could not justify, given the small sample size for each experiment. Additionally, the data integrity of some of the cognitive tasks and standardized questionnaires used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing MRI procedures. The inability to effectively communicate MRI safety procedures in a language other than English could compromise the safety of non-English speaking participants. * Contraindication to MRI as determined by MRI Safety Screening form. Nicotine Dependent Arm * Participants cannot self-report compromised respiratory function such as severe obstructive sleep apnea or severe chronic obstructive pulmonary disease. * Participants cannot meet DSM-5 criteria for moderate or severe ADHD. Control Arm * May not have used any nicotine product more than once per week in the past year. Must have an expired carbon monoxide level of less than or equal to 5 ppm. * Must not have a history of excessive substance use that may impact reward function, as evaluated by the PI, MAI, and/or designee. * Current pharmacological treatment for opioid use disorder (i.e., use of methadone) * May not have (or currently be treated/medicated for) any diagnoses/conditions contraindicated for use of methylphenidate. * Participants may not have a diagnosis of moderate or severe ADHD (irrespective of medication use) or present with undiagnosed ADHD during screening.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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How to take part

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  1. The study's own enquiry address

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  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • National Institute on Drug Abuse

    RECRUITING

    Baltimore, Maryland, 21224, United States

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