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NCT Number: NCT07802990

Lemborexant for Cannabis Use Disorder

The goal of this clinical trial is to investigate the use of Lemborexant as a treatment for moderate to severe Cannabis Use Disorder (CUD). The main questions it aims to answer are:

1. Is Lemborexant safe, feasible, and tolerable to use in the CUD population? 2. Will the use of Lemborexant for CUD help to decrease cannabis use, improve sleep, decrease cannabis withdrawal symptoms, and improve cognition?

Researchers will compare 10mg Lemborexant to placebo.

Participants will:

* Take 10mg Lemborexant (or placebo) nightly for 21 nights (treatment phase). * Wear an actigraphy watch continuously for the treatment phase. * Complete a pre-screen survey, attend an in-person screening session, 4 in-person lab visits (weekly from days 0-21), and a virtual follow-up visit 2 weeks after the treatment phase. * Complete a short daily survey for 35 days total.

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Key information

Conditions

Cannabis Use Disorder Behavior Behavior, Addictive Chemically-Induced Disorders Compulsive Behavior Impulsive Behavior Marijuana Abuse Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Calgary (Foothills Campus)

Calgary, Alberta, T2N4N1, Canada

Location contact

Sophie J Bell, BSc

CONTACT

[email protected]

587-893-0257

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lemborexant 10mg

Drug

21 days of 10mg Lemborexant, taken nightly.

Placebo

Drug

21 days of visually-matched placebo, taken nightly.

Brief behavioural intervention

Behavioral

Participants will receive a brief behavioural intervention at the in-person study visits aimed at helping participants identify ways to reduce their cannabis use.

Primary outcomes

  1. Feasibility: Participant Recruitment Rate

    Time frame: From first participant in until study closure (estimated 24 months).

    Measured by assessing the number of participants recruited into the study (28 anticipated) throughout study duration (24 months estimated).

  2. Feasibility: Participant Retention Percentage

    Time frame: From first participant in until study closure (estimated 24 months).

    Measuring the number of participants who complete the study compared to the total number of study participants, displayed as a percentage (%).

  3. Tolerability: Participant Drop-Out Rates

    Time frame: From first participant in until study closure (estimated 24 months).

    Measured by comparing frequency of participant drop-outs in treatment versus control groups.

  4. Safety: Adverse Event Frequency

    Time frame: Participants will have the opportunity to report adverse events daily during the study treatment phase (days 0-21).

    Measured by comparing the frequency of adverse events in the treatment versus control groups.

  5. Safety: MADRS-S Depression

    Time frame: The MADRS-S will be administered on days 0, 7, 14, and 21 during the study treatment phase (days 0-21).

    Measured using the Montgomery-Åsberg Depression Rating Scale - Self Report (MADRS-S) which scores depression from 0-54, with higher scores indicating worse depression.

  6. Safety: C-SSRS Suicidality

    Time frame: The C-SSRS will be administered on days 0, 7, 14, and 21 during the study treatment phase (days 0-21).

    Measured using the Columbia Suicide Severity Rating Scale (C-SSRS), which uses Yes/No answers to categorize into No, Low, Moderate, or High risk.

Secondary outcomes

  1. Sleep (Objective): Actigraphy Data

    Time frame: Measured continuously during the study treatment phase (days 0-21).

    Participants will wear actigraphy watches continuously during the study treatment phase in order to measure objective sleep data.

  2. Sleep (Subjective): PSQI

    Time frame: The PSQI will be administered at pre-screening and day 21.

    The Pittsburgh Sleep Quality Index (PSQI) will be used as a subjective measure of sleep. Scores can range from 0-21, with higher scores indicating worse sleep.

  3. Sleep (Subjective): LSEQ

    Time frame: Participants will take the LSEQ on days 0, 7, 14, and 21 throughout the study treatment phase (days 0-21).

    The Leeds Sleep Evaluation Questionnaire (LSEQ) is a subjective measure of sleep which uses a 100mm visual analog scale, with lower scores being indicative of worse sleep.

  4. Sleep (Subjective): Daily Diaries CSD

    Time frame: Daily diaries will be completed daily during the study treatment phase (days 0-21).

    Participants will complete daily diaries each morning via REDCap, which will include questions regarding their prior night's sleep from the Consensus Sleep Diary (CSD).

  5. Cannabis Use (Objective): Plasma THC and Metabolites

    Time frame: Blood draws will occur on days 0 and 21 during the study treatment phase (days 0-21).

    Blood draws will be performed in order to measure plasma THC and metabolite levels as an objective measure of cannabis use.

  6. Cannabis Use (Subjective): EC-TLFB

    Time frame: The EC-TLFB will be administered on days 0, 7, 14, and 21 during the study treatment phase (days 0-21).

    The Enhanced Cannabis Timeline Followback (EC-TLFB) will be administered during study visits in order to subjectively assess participant cannabis use.

  7. Cannabis Use (Subjective): Daily Diaries

    Time frame: Daily diaries will be completed daily during the study treatment phase (days 0-21).

    Participants will complete daily diaries each morning via REDCap, which will include questions regarding their cannabis use from the day prior.

  8. Cannabis Use (Subjective): DFAQ-CU

    Time frame: The DFAQ-CU will be administered on days 0 and 21 during the study treatment phase (days 0-21).

    The Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use (DFAQ-CU) measures multiple aspects of cannabis consumption in participants, and will be used as part of our subjective cannabis use measurements.

  9. Cannabis Withdrawal: Daily Diaries Modified MWC

    Time frame: Daily diaries will be completed daily during the study treatment phase (days 0-21).

    The Marijuana Withdrawal Checklist (MWC) asks participants to score their severity of 22 marijuana withdrawal symptoms. On a scale of 0-66, higher scores indicate worse marijuana withdrawal symptoms. We have adapted the MWC to ask participants about their prior day's symptoms, and included it as part of the REDCap daily diaries.

  10. Cognition: Divided Attention

    Time frame: Divided attention cognitive tasks will be administered on days 0 and 21 during the study treatment phase (days 0-21).

    Divided attention cognitive tasks assess participants' ability to focus on one task versus multiple tasks, with less difference between the them indicating better cognitive outcomes.

  11. Cognition: Working Memory

    Time frame: N-back and word memory tasks will be administered on days 0 and 21 during the study treatment phase (days 0-21).

    Working memory will be assessed via N-back and word memory tasks, with better scores being indicative of better cognitive function.

  12. Cognition: Planning via Tower of London

    Time frame: Tower of London will be administered on days 0 and 21 during the study treatment phase (days 0-21).

    The Tower of London task assesses participant planning ability, with higher scores indicative of better planning and cognition.

Other outcomes

  1. Follow-Up Outcome (Safety): Adverse Event Frequency

    Time frame: Participants will have the opportunity to report adverse events daily during the study follow-up phase (days 22-35).

    Measured by comparing the frequency of adverse events in the treatment versus control groups.

  2. Follow-Up Outcome (Safety): Depression

    Time frame: The MADRS-S will be administered on day 35 during the study follow-up phase (days 22-35).

    Measured using the Montgomery-Åsberg Depression Rating Scale - Self Report (MADRS-S) which scores depression from 0-54, with higher scores indicating worse depression.

  3. Follow-Up Outcome (Safety): Suicidality

    Time frame: The C-SSRS will be administered on day 35 during the study follow-up phase (days 22-35).

    Measured using the Columbia Suicide Severity Rating Scale (C-SSRS), which uses Yes/No answers to categorize into No, Low, Moderate, or High risk.

  4. Follow-Up Outcome (Sleep): LSEQ

    Time frame: Participants will take the LSEQ on day 35 during the study follow-up phase (days 22-35).

    The Leeds Sleep Evaluation Questionnaire (LSEQ) is a subjective measure of sleep which uses a 100mm visual analog scale, with lower scores being indicative of worse sleep.

  5. Follow-Up Outcome (Sleep): Daily Diaries CSD

    Time frame: Daily diaries will be completed daily during the study follow-up phase (days 22-35).

    Participants will complete daily diaries each morning via REDCap, which will include questions regarding their prior night's sleep from the Consensus Sleep Diary (CSD).

  6. Follow-Up Outcome (Cannabis Use): EC-TLFB

    Time frame: The EC-TLFB will be administered on day 35 during the study follow-up phase (days 22-35).

    The Enhanced Cannabis Timeline Followback (EC-TLFB) will be administered during study visits in order to subjectively assess participant cannabis use.

  7. Follow-Up Outcome (Cannabis Use): Daily Diaries

    Time frame: Daily diaries will be completed daily during the study follow-up phase (days 22-35).

    Participants will complete daily diaries each morning via REDCap, which will include questions regarding their cannabis use from the day prior.

  8. Follow-Up Outcome (Withdrawal): Daily Diaries Modified MWC

    Time frame: The modified MWC will be completed daily during the study follow-up phase (days 22-35).

    The Marijuana Withdrawal Checklist (MWC) asks participants to score their severity of 22 marijuana withdrawal symptoms. On a scale of 0-66, higher scores indicate worse marijuana withdrawal symptoms. We have adapted the MWC to ask participants about their prior day's symptoms, and included it in the REDCap daily diaries.

Study contacts

Contact information is provided by the study sponsor or research team.

Sophie J Bell, BSc

CONTACT

[email protected]

587-893-0257

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

Lemborexant as a Potential Pharmacotherapy for the Treatment of Cannabis Use Disorder (CUD)

Acronym: LemboCAN

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 3, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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