Cannabis Use DisorderPhase 1/2LemboCANNCT07802990
Lemborexant for Cannabis Use Disorder
A Phase 1/2 study testing Lemborexant 10mg and Brief Behavioural Intervention in people with Cannabis Use Disorder, run by University of Calgary at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cannabis Use Disorder
- What is being tested?
- Lemborexant 10mg and Brief Behavioural Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2026to Nov 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe Cannabis Use Disorder.
- Ability to read/write in English.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
University of Calgary (Foothills Campus)
Calgary, Alberta, T2N4N1
Sophie J Bell, BSc, 587-893-0257, sophie.bell@ucalgary.ca
About this study
Official title: Lemborexant as a Potential Pharmacotherapy for the Treatment of Cannabis Use Disorder (CUD)
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:
- Is Lemborexant safe, feasible, and tolerable to use in the CUD population?
- Will the use of Lemborexant for CUD help to decrease cannabis use, improve sleep, decrease cannabis withdrawal symptoms, and improve cognition?
Read more
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.
- Conditions
- Cannabis Use Disorder
- Being tested
- Lemborexant 10mg, Placebo, Brief Behavioural Intervention
- Keywords
- Cannabis Use Disorder, Addiction, Sleep, Lemborexant, Actigraphy, Clinical trial, Cannabis, Marijuana
- Medical subject headings
- Behavior, Addictive, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lemborexant 10mgDrug
21 days of 10mg Lemborexant, taken nightly.
PlaceboDrug
21 days of visually-matched placebo, taken nightly.
Brief Behavioural InterventionBehavioural
Participants will receive a brief behavioural intervention at the in-person study visits aimed at helping participants identify ways to reduce their cannabis use.
| Study group | Role | What they receive |
|---|---|---|
| Lemborexant 10mg | Experimental | Not described Receives: Drug: Lemborexant 10mg; Behavioral: Brief Behavioural Intervention |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; Behavioral: Brief Behavioural Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Participant Recruitment Rate
Measured by assessing the number of participants recruited into the study (28 anticipated) throughout study duration (24 months estimated).
Measured: From first participant in until study closure (estimated 24 months).
Feasibility: Participant Retention Percentage
Measuring the number of participants who complete the study compared to the total number of study participants, displayed as a percentage (%).
Measured: From first participant in until study closure (estimated 24 months).
Tolerability: Participant Drop-Out Rates
Measured by comparing frequency of participant drop-outs in treatment versus control groups.
Measured: From first participant in until study closure (estimated 24 months).
Safety: Adverse Event Frequency
Measured by comparing the frequency of adverse events in the treatment versus control groups.
Measured: Participants will have the opportunity to report adverse events daily during the study treatment phase (days 0-21).
Safety: MADRS-S Depression
Measured using the Montgomery-Åsberg Depression Rating Scale - Self Report (MADRS-S) which scores depression from 0-54, with higher scores indicating worse depression.
Measured: The MADRS-S will be administered on days 0, 7, 14, and 21 during the study treatment phase (days 0-21).
Safety: C-SSRS Suicidality
Measured using the Columbia Suicide Severity Rating Scale (C-SSRS), which uses Yes/No answers to categorize into No, Low, Moderate, or High risk.
Measured: The C-SSRS will be administered on days 0, 7, 14, and 21 during the study treatment phase (days 0-21).
Secondary outcomes (12)
Sleep (Objective): Actigraphy Data
Participants will wear actigraphy watches continuously during the study treatment phase in order to measure objective sleep data.
Measured: Measured continuously during the study treatment phase (days 0-21).
Sleep (Subjective): PSQI
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.
Measured: The PSQI will be administered at pre-screening and day 21.
Sleep (Subjective): LSEQ
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.
Measured: Participants will take the LSEQ on days 0, 7, 14, and 21 throughout the study treatment phase (days 0-21).
Sleep (Subjective): Daily Diaries CSD
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).
Measured: Daily diaries will be completed daily during the study treatment phase (days 0-21).
Cannabis Use (Objective): Plasma THC and Metabolites
Blood draws will be performed in order to measure plasma THC and metabolite levels as an objective measure of cannabis use.
Measured: Blood draws will occur on days 0 and 21 during the study treatment phase (days 0-21).
Cannabis Use (Subjective): EC-TLFB
The Enhanced Cannabis Timeline Followback (EC-TLFB) will be administered during study visits in order to subjectively assess participant cannabis use.
Measured: The EC-TLFB will be administered on days 0, 7, 14, and 21 during the study treatment phase (days 0-21).
Cannabis Use (Subjective): Daily Diaries
Participants will complete daily diaries each morning via REDCap, which will include questions regarding their cannabis use from the day prior.
Measured: Daily diaries will be completed daily during the study treatment phase (days 0-21).
Cannabis Use (Subjective): DFAQ-CU
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.
Measured: The DFAQ-CU will be administered on days 0 and 21 during the study treatment phase (days 0-21).
Cannabis Withdrawal: Daily Diaries Modified MWC
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.
Measured: Daily diaries will be completed daily during the study treatment phase (days 0-21).
Cognition: Divided Attention
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.
Measured: Divided attention cognitive tasks will be administered on days 0 and 21 during the study treatment phase (days 0-21).
Cognition: Working Memory
Working memory will be assessed via N-back and word memory tasks, with better scores being indicative of better cognitive function.
Measured: N-back and word memory tasks will be administered on days 0 and 21 during the study treatment phase (days 0-21).
Cognition: Planning via Tower of London
The Tower of London task assesses participant planning ability, with higher scores indicative of better planning and cognition.
Measured: Tower of London will be administered on days 0 and 21 during the study treatment phase (days 0-21).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into either the treatment group (10mg Lemborexant) or the control group (placebo) at a 1:1 ratio.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David N Crockford, MD, Principal investigator, University of CalgaryLeah M Mayo, PhD, Principal investigator, University of CalgaryStephanie L Borgland, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802990
- Sponsor's protocol ID
- REB26-0681
- Acronym
- LemboCAN
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lemborexant as a Potential Pharmacotherapy for the Treatment of Cannabis Use Disorder (CUD)
- ClinicalTrials.gov ID
- NCT07802990
- Acronym / sponsor ID
- LemboCAN / REB26-0681
- Conditions
- Cannabis Use Disorder
- Keywords
- Cannabis Use Disorder, Addiction, Sleep, Lemborexant, Actigraphy, Clinical trial, Cannabis, Marijuana
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is Lemborexant safe, feasible, and tolerable to use in the CUD population?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into either the treatment group (10mg Lemborexant) or the control group (placebo) at a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Lemborexant 10mg | Experimental | Drug: Lemborexant 10mg, Behavioral: Brief Behavioural Intervention |
| Placebo | Placebo comparator | Drug: Placebo, Behavioral: Brief Behavioural Intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Moderate to severe Cannabis Use Disorder.
- Ability to read/write in English.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lemborexant 10mg21 days of 10mg Lemborexant, taken nightly. | Drug | Lemborexant 10mg |
| Placebo21 days of visually-matched placebo, taken nightly. | Drug | Placebo |
| Brief Behavioural InterventionParticipants will receive a brief behavioural intervention at the in-person study visits aimed at helping participants identify ways to reduce their cannabis use. | Behavioural | Lemborexant 10mg, Placebo |
Primary outcome
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).
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 (%).
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.
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.
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.
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.
12 secondary outcomes
Sleep (Objective): Actigraphy Data
Time frame: Measured continuously during the study treatment phase (days 0-21).
Sleep (Subjective): PSQI
Time frame: The PSQI will be administered at pre-screening and day 21.
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).
Sleep (Subjective): Daily Diaries CSD
Time frame: Daily diaries will be completed daily during the study treatment phase (days 0-21).
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).
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).
Cannabis Use (Subjective): Daily Diaries
Time frame: Daily diaries will be completed daily during the study treatment phase (days 0-21).
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).
Cannabis Withdrawal: Daily Diaries Modified MWC
Time frame: Daily diaries will be completed daily during the study treatment phase (days 0-21).
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).
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David N Crockford, MD principal investigator
University of Calgary
Leah M Mayo, PhD principal investigator
University of Calgary
Stephanie L Borgland, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lemborexant 10mg and Brief Behavioural Intervention in people with Cannabis Use Disorder, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie J Bell, BSc (587-893-0257, sophie.bell@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Participant Recruitment Rate (time frame: From first participant in until study closure (estimated 24 months).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.