Cannabidiol (CBD) for the Treatment of Alcohol Withdrawal
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|ClinicalTrials.gov Identifier: NCT04205682|
Recruitment Status : Not yet recruiting
First Posted : December 19, 2019
Last Update Posted : January 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Withdrawal Alcohol Dependence||Drug: Cannabidiol Drug: Placebo||Early Phase 1|
New treatment strategies for treating symptoms of alcohol dependence are urgently needed. Although alcohol related disorders are a leading cause of preventable death in Australia, their treatment is generally not evidence-based. Contemporary treatment for managing alcohol withdrawal in Australia involves administration of benzodiazepines that, while often effective for managing withdrawal symptoms, have concerns regarding their use including: a major abuse liability potential in this population; their sedating effects and potential for adverse events (e.g. falls, overdose, cognitive impairment) if used in combination with other sedatives; and an increased risk of relapse due to symptoms of alcohol dependence that return after cessation of treatment (e.g. increased sleep problems and anxiety). However, no other safe and effective alternatives to benzodiazepines in treating alcohol withdrawal have yet been demonstrated.
This project will pilot the clinical efficacy and tolerability of Cannabidiol (CBD) relative to placebo in the treatment of alcohol withdrawal in an inpatient setting across two study sites.
This is a double-blind, randomised controlled design. The trial will recruit 52 participants undergoing alcohol withdrawal, using a 1:1 random allocation into one of two treatment groups as follows: (1) CBD (Day 1: 1200 mg/day; Day 2-4: 800 mg/day; Day 5: placebo washout; n = 26), or (2) matched placebo (n = 26). All participants will be administered a symptom triggered diazepam medication regimen, as per conventional best-practice management of alcohol withdrawal.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomised Controlled Trial of Cannabidiol (CBD) for the Treatment of Alcohol Withdrawal|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
Experimental: Cannabidiol (CBD)
Drug: Cannabidiol (day 1: 1200 mg (800 mg BD); day 2-4: 800 mg (400 mg BD); day 5: placebo BD).
CBD capsules administered BD for 4-days (800-1200 mg/day), placebo day 5
Placebo Comparator: Placebo
Drug: Placebo (days 1-5: placebo matched BD)
Placebo capsules administered BD for 5 days
- Diazepam [ Time Frame: 5 day admission period ]Diazepam use over the 5-day withdrawal period (which due to symptom triggered regimen is a proxy measure for withdrawal severity). Measured by total diazepam use over 5 day period.
- Alcohol Withdrawal Severity [ Time Frame: 5 day admission period ]Measured by Alcohol Withdrawal Scale (AWS), minimum score is 0, maximum score is 27 where higher scores indicate greater withdrawal severity.
- Self-reported Alcohol Withdrawal Severity [ Time Frame: 5 day admission period (twice daily) ]As measured by the Alcohol Withdrawal Severity Checklist (AWSC), a self-report measure of withdrawal severity, minimum score is 0, maximum score is 64 where higher scores indicate greater self-reported withdrawal severity.
- Self-reported alcohol craving [ Time Frame: Baseline, Day 5, and Day 12 and 33 Follow Up ]As measured by the Penn Alcohol Craving Scale (PACS), minimum score is 0, maximum score is 30 where higher scores indicate greater alcohol craving
- Self-reported urges to drink [ Time Frame: Twice Daily, days 1-5 ]As measured by the Alcohol Urge Questionnaire (AUQ), minimum score is 8, maximum score is 56, where higher scores indicate greater urges to drink
- Actiwatch for sleep quality [ Time Frame: 5 day admission period ]as measured using data obtained from the actiwatch worn by participants for duration of inpatient stay
- Self-reported sleep quality [ Time Frame: Baseline, Day 5, and Follow Up (Day 12, Day 33) ]as measured using the Insomnia Severity Index (ISI), minimum score is 0, maximum score is 28, where higher scores indicate greater insomnia severity.
- Subjective measure of patient satisfaction [ Time Frame: Day 5 and follow up (day 12 and 33) ]Measured using the Treatment Satisfaction Questionnaire for Medication (TSQM), minimum score is 13, maximum score is 80, where higher scores indicate greater treatment satisfaction.
- Liver function tests for clinical markers of liver injury [ Time Frame: Baseline and follow up (day 12 and 33). ]as measured by levels of liver enzymes, Alanine Transaminase (ALT), Alkaline Phosphatase (ALP) and Aspartate Transaminase (AST) in blood
- Plasma levels of benzodiazepines [ Time Frame: Daily (days 1-5) ]As measured by concentration of benzodiazepines in blood plasma
- Plasma levels of cannabidiol [ Time Frame: Daily (days 1-5) ]As measured by concentration of cannabidiol in blood plasma
- Mood [ Time Frame: Baseline, day 5 and follow up day 12 and 33. ]Depression, Anxiety and Stress Symptoms measured by the Depression, Anxiety and Stress Scale (DASS-21), minimum score is 0, maximum score is 63, where higher scores indicate greater levels of depression, anxiety and stress.
- Cognitive Functioning [ Time Frame: Baseline, day 5 and follow up day 12 and 33. ]As measured by the Montreal Cognitive Assessment (MoCA), maximum score is 30 and where higher scores indicate greater cognitive functioning.
- Cognitive Functioning [ Time Frame: Baseline, day 5 and follow up day 12 and 33. ]Executive functioning measured by time taken to complete the Trail Making Test A and B (in seconds), where lower scores indicate greater functioning.
- Comorbid Anxiety Disorders [ Time Frame: 4 week follow up (day 33) ]Assessed using the MINI Neuropsychiatric Interview indicating the presence or absence of anxiety disorders
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04205682
|Contact: Kirsten Morley, PhDemail@example.com|
|Australia, New South Wales|
|Sydney and Sydney Eye Hospital|
|Sydney, New South Wales, Australia, 2000|
|Contact: Nicholas Lintzeris, MBBS firstname.lastname@example.org|
|Principal Investigator: Nicholas Lintzeris, MBBS|
|Royal Prince Alfred Hospital|
|Sydney, New South Wales, Australia, 2050|
|Contact: Kirsten Morley, PhD +61295153636 email@example.com|
|Principal Investigator: Paul Haber, MBBS|
|Principal Investigator:||Paul Haber, MBBS||Sydney Local Health District|
|Principal Investigator:||Nicholas Lintzeris, MBBS||South Eastern Sydney Local Health District|
|Principal Investigator:||Iain McGregor, PhD||University of Sydney|
|Principal Investigator:||Kirsten Morley, PhD||University of Sydney|