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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04205682
Registration number
NCT04205682
Ethics application status
Date submitted
5/11/2019
Date registered
19/12/2019
Date last updated
9/01/2020
Titles & IDs
Public title
Cannabidiol (CBD) for the Treatment of Alcohol Withdrawal
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Scientific title
A Randomised Controlled Trial of Cannabidiol (CBD) for the Treatment of Alcohol Withdrawal
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Secondary ID [1]
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X18-0163
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alcohol Withdrawal
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Alcohol Dependence
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Condition category
Condition code
Mental Health
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Addiction
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Cannabidiol
Treatment: Drugs - Placebo
Experimental: Cannabidiol (CBD) - Drug: Cannabidiol (day 1: 1200 mg (800 mg BD); day 2-4: 800 mg (400 mg BD); day 5: placebo BD).
Placebo comparator: Placebo - Drug: Placebo (days 1-5: placebo matched BD)
Treatment: Drugs: Cannabidiol
CBD capsules administered BD for 4-days (800-1200 mg/day), placebo day 5
Treatment: Drugs: Placebo
Placebo capsules administered BD for 5 days
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Diazepam
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Assessment method [1]
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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.
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Timepoint [1]
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5 day admission period
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Secondary outcome [1]
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Alcohol Withdrawal Severity
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Assessment method [1]
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Measured by Alcohol Withdrawal Scale (AWS), minimum score is 0, maximum score is 27 where higher scores indicate greater withdrawal severity.
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Timepoint [1]
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5 day admission period
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Secondary outcome [2]
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Self-reported Alcohol Withdrawal Severity
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Assessment method [2]
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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.
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Timepoint [2]
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5 day admission period (twice daily)
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Secondary outcome [3]
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Self-reported alcohol craving
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Assessment method [3]
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As measured by the Penn Alcohol Craving Scale (PACS), minimum score is 0, maximum score is 30 where higher scores indicate greater alcohol craving
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Timepoint [3]
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Baseline, Day 5, and Day 12 and 33 Follow Up
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Secondary outcome [4]
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Self-reported urges to drink
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Assessment method [4]
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As measured by the Alcohol Urge Questionnaire (AUQ), minimum score is 8, maximum score is 56, where higher scores indicate greater urges to drink
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Timepoint [4]
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Twice Daily, days 1-5
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Secondary outcome [5]
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Actiwatch for sleep quality
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Assessment method [5]
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as measured using data obtained from the actiwatch worn by participants for duration of inpatient stay
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Timepoint [5]
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5 day admission period
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Secondary outcome [6]
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Self-reported sleep quality
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Assessment method [6]
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as measured using the Insomnia Severity Index (ISI), minimum score is 0, maximum score is 28, where higher scores indicate greater insomnia severity.
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Timepoint [6]
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Baseline, Day 5, and Follow Up (Day 12, Day 33)
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Secondary outcome [7]
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Subjective measure of patient satisfaction
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Assessment method [7]
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Measured using the Treatment Satisfaction Questionnaire for Medication (TSQM), minimum score is 13, maximum score is 80, where higher scores indicate greater treatment satisfaction.
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Timepoint [7]
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Day 5 and follow up (day 12 and 33)
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Secondary outcome [8]
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Liver function tests for clinical markers of liver injury
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Assessment method [8]
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as measured by levels of liver enzymes, Alanine Transaminase (ALT), Alkaline Phosphatase (ALP) and Aspartate Transaminase (AST) in blood
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Timepoint [8]
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Baseline and follow up (day 12 and 33).
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Secondary outcome [9]
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Plasma levels of benzodiazepines
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Assessment method [9]
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As measured by concentration of benzodiazepines in blood plasma
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Timepoint [9]
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Daily (days 1-5)
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Secondary outcome [10]
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Plasma levels of cannabidiol
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Assessment method [10]
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As measured by concentration of cannabidiol in blood plasma
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Timepoint [10]
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Daily (days 1-5)
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Secondary outcome [11]
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Mood
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Assessment method [11]
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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.
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Timepoint [11]
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Baseline, day 5 and follow up day 12 and 33.
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Secondary outcome [12]
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Cognitive Functioning
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Assessment method [12]
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As measured by the Montreal Cognitive Assessment (MoCA), maximum score is 30 and where higher scores indicate greater cognitive functioning.
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Timepoint [12]
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Baseline, day 5 and follow up day 12 and 33.
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Secondary outcome [13]
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Cognitive Functioning
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Assessment method [13]
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Executive functioning measured by time taken to complete the Trail Making Test A and B (in seconds), where lower scores indicate greater functioning.
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Timepoint [13]
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Baseline, day 5 and follow up day 12 and 33.
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Secondary outcome [14]
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Comorbid Anxiety Disorders
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Assessment method [14]
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Assessed using the MINI Neuropsychiatric Interview indicating the presence or absence of anxiety disorders
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Timepoint [14]
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4 week follow up (day 33)
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Eligibility
Key inclusion criteria
* Aged 18-65 years;
* At least one prior episode 2 days or longer in duration during which the participant experienced withdrawal symptoms that caused significant incapacitation (e.g. inability to work or do normal activities) OR at least one prior inpatient or outpatient medical detoxification during which the participant exhibited withdrawal symptoms of significant magnitude that sedative-hypnotic or anticonvulsant medication was required at least once on 2 consecutive days after cessation of or reduction in the use of alcohol following 2 weeks or more of heavy daily consumption;
* Average consumption of at least 8 standard drinks per day for at least 2 weeks prior to enrolment in the study;
* Adequate cognition and English language skills to give valid consent and complete research interviews;
* Willingness to give written informed consent
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Treatment/ingestion during the previous week of benzodiazepines or other sedative-hypnotic medications or history of recent chronic treatment with sedative-hypnotic medication as evidenced by a negative urine drug screen at baseline
* History of alcohol withdrawal related seizures
* Substance use in the previous week, defined as > 3 times per week (not including nicotine or caffeine), inclusive of non-prescribed pharmaceuticals (ATOP to be collected at screening)
* Active major psychiatric disorder associated with psychosis, or significant suicide risk (e.g. Bipolar, Schizophrenia)
* Pregnancy or lactation - Women shall be advised to use reliable contraception for the duration of drug therapy and a urine pregnancy test will be performed where necessary
* History of confirmed seizures during adulthood, and/or current use of anti-epileptic drugs (AED)
* Diagnosis of epilepsy, and/or current use of anti-epileptic drugs (AED)
* Serious medical illness impacting on safety/participation, defined as an unstable medical state in the opinion of the trial medical officer
* Low body weight (body mass index < 17)
* Severe cognitive impairment or insufficient English or literacy to complete study processes
* Concurrent use of drugs potentially exacerbated by CBD via CYP3A5
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 0
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/01/2020
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/01/2021
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Actual
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Sample size
Target
52
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Sydney and Sydney Eye Hospital - Sydney
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Recruitment hospital [2]
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Royal Prince Alfred Hospital - Sydney
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Recruitment postcode(s) [1]
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2000 - Sydney
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Recruitment postcode(s) [2]
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2050 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
South West Sydney Local Health District
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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University of Sydney
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Address [1]
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Country [1]
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Other collaborator category [2]
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Government body
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Name [2]
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South Eastern Sydney Local Health District
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT04205682
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Paul Haber, MBBS
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Address
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Sydney Local Health District
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Kirsten Morley, PhD
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Address
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Country
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Phone
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+61295153636
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04205682
Download to PDF