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Can a sleep pill curb cannabis addiction?

NCT ID NCT07802990

Disease control Sponsor: University of Calgary Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

Researchers are testing whether lemborexant, a sleep medication, can help people with moderate to severe cannabis use disorder cut back on cannabis, improve sleep, and ease withdrawal symptoms. The trial compares 21 nights of lemborexant against a placebo, with participants also receiving brief behavioral support. The study tracks safety, tolerability, sleep quality, and cannabis use over several weeks.

What this could mean

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

Active substance
Lemborexant, a sleep medication taken nightly for 21 days, compared against a placebo.
What this could lead to
If it works, lemborexant could become a new medication to help people with cannabis use disorder reduce their use and manage withdrawal and sleep problems.
What could go wrong
This is an early, small trial focused on safety and feasibility, so it may not show clear benefits. Lemborexant can cause side effects like drowsiness, and it is not yet proven for this condition.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 28 people

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

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Nov 2028

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 65 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: * Moderate to severe Cannabis Use Disorder. * Ability to read/write in English. Exclusion Criteria: * Known allergies or hypersensitivities to Lemborexant. * Use of any Orexin-Antagonist in the past 3 months. * Current or recent (within the past 12 weeks) participation in a clinical trial involving medication administration. * Narcolepsy, Complex sleep behaviors, sleep apnea, restless leg syndrome, and Periodic Limb Movement Disorder. * Currently undergoing treatment for CUD. * Any hospitalization or emergency department visit related to cannabis use. * Moderate to severe hepatic impairment. * Past or ongoing moderate to severe psychiatric disorders. * Active suicidal ideation or serious attempt within the past 3 years. * Epilepsy or history of seizures. * Blood pressure over 160/95mmHg at the screening session. * Current pregnancy or nursing, trying to become pregnant, or unwilling to use acceptable method of contraception during the study.

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Conditions

The condition(s) this trial relates to.

Behavior, Addictive cannabis dependence

As listed by the trial registrant

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

Cannabis use disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

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

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Calgary (Foothills Campus)

    Calgary, Alberta, T2N4N1, Canada

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