Lemborexant for Cannabis Use Disorder
ConditionCannabis Use Disorder
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Calgary
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Moderate to severe Cannabis Use Disorder.
Ability to read/write in English.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Lemborexant 10mg
Drug21 days of 10mg Lemborexant, taken nightly.
Placebo
Drug21 days of visually-matched placebo, taken nightly.
Brief Behavioural Intervention
BehavioralParticipants will receive a brief behavioural intervention at the in-person study visits aimed at helping participants identify ways to reduce their cannabis use.
Treatment groups
28 Participants
are divided into 2 treatment groupsGroup A: Lemborexant 10mgExperimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
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).2
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).3
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).4
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).Secondary outcomes
1
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).2
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 21.3
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).4
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).Other outcomes
1
Follow-Up Outcome (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 follow-up phase (days 22-35).2
Follow-Up Outcome (Safety): 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 day 35 during the study follow-up phase (days 22-35).3
Follow-Up Outcome (Safety): 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 day 35 during the study follow-up phase (days 22-35).4
Follow-Up Outcome (Sleep): 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 day 35 during the study follow-up phase (days 22-35).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: