Lemborexant for Cannabis Use Disorder

Condition(s) studied

Investigational drug(s) / intervention(s)

Lemborexant 10mg: 21 days of 10mg Lemborexant, taken nightly.

Placebo: 21 days of visually-matched placebo, taken nightly.

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.

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.

Eligibility

Primary outcome measure(s)

• Feasibility: Participant Recruitment Rate — 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 — 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 — 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 — 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 — 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 — 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.

Trial sites (1)

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