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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Scientific title
A Randomised Controlled Trial of Cannabidiol (CBD) for the Treatment of Alcohol Withdrawal
Secondary ID [1] 0 0
X18-0163
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol Withdrawal 0 0
Alcohol Dependence 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Addiction

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Diazepam
Timepoint [1] 0 0
5 day admission period
Secondary outcome [1] 0 0
Alcohol Withdrawal Severity
Timepoint [1] 0 0
5 day admission period
Secondary outcome [2] 0 0
Self-reported Alcohol Withdrawal Severity
Timepoint [2] 0 0
5 day admission period (twice daily)
Secondary outcome [3] 0 0
Self-reported alcohol craving
Timepoint [3] 0 0
Baseline, Day 5, and Day 12 and 33 Follow Up
Secondary outcome [4] 0 0
Self-reported urges to drink
Timepoint [4] 0 0
Twice Daily, days 1-5
Secondary outcome [5] 0 0
Actiwatch for sleep quality
Timepoint [5] 0 0
5 day admission period
Secondary outcome [6] 0 0
Self-reported sleep quality
Timepoint [6] 0 0
Baseline, Day 5, and Follow Up (Day 12, Day 33)
Secondary outcome [7] 0 0
Subjective measure of patient satisfaction
Timepoint [7] 0 0
Day 5 and follow up (day 12 and 33)
Secondary outcome [8] 0 0
Liver function tests for clinical markers of liver injury
Timepoint [8] 0 0
Baseline and follow up (day 12 and 33).
Secondary outcome [9] 0 0
Plasma levels of benzodiazepines
Timepoint [9] 0 0
Daily (days 1-5)
Secondary outcome [10] 0 0
Plasma levels of cannabidiol
Timepoint [10] 0 0
Daily (days 1-5)
Secondary outcome [11] 0 0
Mood
Timepoint [11] 0 0
Baseline, day 5 and follow up day 12 and 33.
Secondary outcome [12] 0 0
Cognitive Functioning
Timepoint [12] 0 0
Baseline, day 5 and follow up day 12 and 33.
Secondary outcome [13] 0 0
Cognitive Functioning
Timepoint [13] 0 0
Baseline, day 5 and follow up day 12 and 33.
Secondary outcome [14] 0 0
Comorbid Anxiety Disorders
Timepoint [14] 0 0
4 week follow up (day 33)

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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/01/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2021
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney and Sydney Eye Hospital - Sydney
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
2050 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
South West Sydney Local Health District
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Sydney
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
South Eastern Sydney Local Health District
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04205682
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Haber, MBBS
Address 0 0
Sydney Local Health District
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kirsten Morley, PhD
Address 0 0
Country 0 0
Phone 0 0
+61295153636
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04205682