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Lemborexant for Cannabis Use Disorder

NCT07802990 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-09-03

No results posted yet for this study

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. 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.

Conditions

  • Cannabis Use Disorder

Interventions

DRUG

Lemborexant 10mg

21 days of 10mg Lemborexant, taken nightly.

DRUG

Placebo

21 days of visually-matched placebo, taken nightly.

BEHAVIORAL

Brief Behavioural Intervention

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

Sponsors & Collaborators

Principal Investigators

  • David N Crockford, MD · University of Calgary

  • Leah M Mayo, PhD · University of Calgary

  • Stephanie L Borgland, PhD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2028-11-30
Completion
2028-11-30

Countries

  • Canada

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07802990 on ClinicalTrials.gov