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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
28
21 days of 10mg Lemborexant, taken nightly.
21 days of visually-matched placebo, taken nightly.
Participants will receive a brief behavioural intervention at the in-person study visits aimed at helping participants identify ways to reduce their cannabis use.
University of Calgary (Foothills Campus)
Calgary, Alberta, Canada
Feasibility: Participant Recruitment Rate
Measured by assessing the number of participants recruited into the study (28 anticipated) throughout study duration (24 months estimated).
Time frame: 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 (%).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: The C-SSRS will be administered on days 0, 7, 14, and 21 during the study treatment phase (days 0-21).
Sleep (Objective): Actigraphy Data
Participants will wear actigraphy watches continuously during the study treatment phase in order to measure objective sleep data.
Time frame: 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.
Time frame: 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.
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
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).
Time frame: 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.
Time frame: 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.
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
Participants will complete daily diaries each morning via REDCap, which will include questions regarding their cannabis use from the day prior.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
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
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.
Time frame: 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.
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
Working memory will be assessed via N-back and word memory tasks, with better scores being indicative of better cognitive function.
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
The Tower of London task assesses participant planning ability, with higher scores indicative of better planning and cognition.
Time frame: Tower of London will be administered on days 0 and 21 during the study treatment phase (days 0-21).