Cannabis Use Disorder
Conditions
Keywords
Cannabis Use Disorder, Addiction, Sleep, Lemborexant, Actigraphy, Clinical trial, Cannabis, Marijuana
Brief 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.
Interventions
DRUGLemborexant 10mg
21 days of 10mg Lemborexant, taken nightly.
DRUGPlacebo
21 days of visually-matched placebo, taken nightly.
BEHAVIORALBrief 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
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants will be randomized into either the treatment group (10mg Lemborexant) or the control group (placebo) at a 1:1 ratio.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Moderate to severe Cannabis Use Disorder. * Ability to read/write in English.
Exclusion criteria
* 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. * Currently undergoing treatment for CUD. * Any hospitalization or emergency department visit related to cannabis use. * Moderate to severe hepatic impairment. * Past or ongoing moderate to severe psychiatric disorders. * Active suicidal ideation or serious attempt within the past 3 years. * Epilepsy or history of seizures. * Blood pressure over 160/95mmHg at the screening session. * Current pregnancy or nursing, trying to become pregnant, or unwilling to use acceptable method of contraception during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep (Subjective): Daily Diaries CSD | Daily diaries will be completed daily during the study treatment phase (days 0-21). | 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). |
| Cannabis Use (Subjective): DFAQ-CU | The DFAQ-CU will be administered on days 0 and 21 during the study treatment phase (days 0-21). | 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. |
| Cannabis Withdrawal: Daily Diaries Modified MWC | Daily diaries will be completed daily during the study treatment phase (days 0-21). | 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. |
| Cognition: Divided Attention | Divided attention cognitive tasks will be administered on days 0 and 21 during the study treatment phase (days 0-21). | 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. |
| Cognition: Working Memory | N-back and word memory tasks will be administered on days 0 and 21 during the study treatment phase (days 0-21). | Working memory will be assessed via N-back and word memory tasks, with better scores being indicative of better cognitive function. |
| Cannabis Use (Objective): Plasma THC and Metabolites | Blood draws will occur on days 0 and 21 during the study treatment phase (days 0-21). | Blood draws will be performed in order to measure plasma THC and metabolite levels as an objective measure of cannabis use. |
| Cognition: Planning via Tower of London | Tower of London will be administered on days 0 and 21 during the study treatment phase (days 0-21). | The Tower of London task assesses participant planning ability, with higher scores indicative of better planning and cognition. |
| Cannabis Use (Subjective): EC-TLFB | The EC-TLFB will be administered on days 0, 7, 14, and 21 during the study treatment phase (days 0-21). | The Enhanced Cannabis Timeline Followback (EC-TLFB) will be administered during study visits in order to subjectively assess participant cannabis use. |
| Cannabis Use (Subjective): Daily Diaries | Daily diaries will be completed daily during the study treatment phase (days 0-21). | Participants will complete daily diaries each morning via REDCap, which will include questions regarding their cannabis use from the day prior. |
| Sleep (Objective): Actigraphy Data | Measured continuously during the study treatment phase (days 0-21). | Participants will wear actigraphy watches continuously during the study treatment phase in order to measure objective sleep data. |
| Sleep (Subjective): PSQI | The PSQI will be administered at pre-screening and day 21. | 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. |
| Sleep (Subjective): LSEQ | Participants will take the LSEQ on days 0, 7, 14, and 21 throughout the study treatment phase (days 0-21). | 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. |
Countries
Canada
Contacts
CONTACTSophie J Bell, BSc
PRINCIPAL_INVESTIGATORDavid N Crockford, MD
University of Calgary
PRINCIPAL_INVESTIGATORLeah M Mayo, PhD
University of Calgary
PRINCIPAL_INVESTIGATORStephanie L Borgland, PhD
University of Calgary
Outcome results
None listed