Lemborexant for Cannabis Use Disorder

Sponsor
University of Calgary
Study ID
NCT07802990
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Cannabis Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Sep 3, 2026
Start date
Nov 30, 2026
Status verified
Aug 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
28 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lemborexant 10mg
  • Placebo Comparator: Placebo

Primary Outcome Measure

Feasibility: Participant Recruitment Rate [ Time Frame: From first participant in until study closure (estimated 24 months). ]

Central Contacts

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