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| Name | Class |
|---|---|
| University of Sydney | OTHER |
| South Eastern Sydney Local Health District | OTHER_GOV |
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This study will explore the effectiveness and tolerability of Cannabidiol (CBD) in the treatment of alcohol withdrawal symptoms in an inpatient setting, in a double-blind randomised placebo-controlled trial.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabidiol (CBD) | Experimental | Drug: Cannabidiol (day 1: 1200 mg (800 mg BD); day 2-4: 800 mg (400 mg BD); day 5: placebo BD). |
|
| Placebo | Placebo Comparator | Drug: Placebo (days 1-5: placebo matched BD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol | Drug | CBD capsules administered BD for 4-days (800-1200 mg/day), placebo day 5 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diazepam | 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. | 5 day admission period |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Withdrawal Severity | Measured by Alcohol Withdrawal Scale (AWS), minimum score is 0, maximum score is 27 where higher scores indicate greater withdrawal severity. | 5 day admission period |
| Self-reported Alcohol Withdrawal Severity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kirsten Morley, PhD | Contact | +61295153636 | kirsten.morley@sydney.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| Paul Haber, MBBS | Sydney Local Health District | Principal Investigator |
| Nicholas Lintzeris, MBBS | South Eastern Sydney Local Health District | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sydney and Sydney Eye Hospital | Sydney | New South Wales | 2000 | Australia |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Placebo capsules administered BD for 5 days |
|
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.
| 5 day admission period (twice daily) |
| Self-reported alcohol craving | As measured by the Penn Alcohol Craving Scale (PACS), minimum score is 0, maximum score is 30 where higher scores indicate greater alcohol craving | Baseline, Day 5, and Day 12 and 33 Follow Up |
| Self-reported urges to drink | As measured by the Alcohol Urge Questionnaire (AUQ), minimum score is 8, maximum score is 56, where higher scores indicate greater urges to drink | Twice Daily, days 1-5 |
| Actiwatch for sleep quality | as measured using data obtained from the actiwatch worn by participants for duration of inpatient stay | 5 day admission period |
| Self-reported sleep quality | as measured using the Insomnia Severity Index (ISI), minimum score is 0, maximum score is 28, where higher scores indicate greater insomnia severity. | Baseline, Day 5, and Follow Up (Day 12, Day 33) |
| Subjective measure of patient satisfaction | Measured using the Treatment Satisfaction Questionnaire for Medication (TSQM), minimum score is 13, maximum score is 80, where higher scores indicate greater treatment satisfaction. | Day 5 and follow up (day 12 and 33) |
| Liver function tests for clinical markers of liver injury | as measured by levels of liver enzymes, Alanine Transaminase (ALT), Alkaline Phosphatase (ALP) and Aspartate Transaminase (AST) in blood | Baseline and follow up (day 12 and 33). |
| Plasma levels of benzodiazepines | As measured by concentration of benzodiazepines in blood plasma | Daily (days 1-5) |
| Plasma levels of cannabidiol | As measured by concentration of cannabidiol in blood plasma | Daily (days 1-5) |
| Mood | 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. | Baseline, day 5 and follow up day 12 and 33. |
| Cognitive Functioning | As measured by the Montreal Cognitive Assessment (MoCA), maximum score is 30 and where higher scores indicate greater cognitive functioning. | Baseline, day 5 and follow up day 12 and 33. |
| Cognitive Functioning | Executive functioning measured by time taken to complete the Trail Making Test A and B (in seconds), where lower scores indicate greater functioning. | Baseline, day 5 and follow up day 12 and 33. |
| Comorbid Anxiety Disorders | Assessed using the MINI Neuropsychiatric Interview indicating the presence or absence of anxiety disorders | 4 week follow up (day 33) |
| Iain McGregor, PhD |
| University of Sydney |
| Principal Investigator |
| Kirsten Morley, PhD | University of Sydney | Principal Investigator |
| Royal Prince Alfred Hospital | Sydney | New South Wales | 2050 | Australia |
|