Cannabidiol (CBD) for the Treatment of Alcohol Withdrawal

NCT04205682 | Unknown Early Phase 1 DMC

• 1 other identifier: X18-0163
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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.

Conditions

Alcohol Withdrawal; Alcohol Dependence

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (14)

• Alcohol Withdrawal Severity

  5 day admission period

• Self-reported Alcohol Withdrawal Severity

  5 day admission period (twice daily)

• Self-reported alcohol craving

  Baseline, Day 5, and Day 12 and 33 Follow Up

• Self-reported urges to drink

  Twice Daily, days 1-5

• Actiwatch for sleep quality

  5 day admission period

Study Arms (2)

Cannabidiol (CBD)

EXPERIMENTAL

Drug: Cannabidiol (day 1: 1200 mg (800 mg BD); day 2-4: 800 mg (400 mg BD); day 5: placebo BD).

Drug: Cannabidiol

Placebo

PLACEBO COMPARATOR

Drug: Placebo (days 1-5: placebo matched BD)

Drug: Placebo

Interventions

Cannabidiol DRUG

CBD capsules administered BD for 4-days (800-1200 mg/day), placebo day 5

Cannabidiol (CBD)

Placebo DRUG

Placebo capsules administered BD for 5 days

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• South West Sydney Local Health District: lead
• University of Sydney: collaborator
• South Eastern Sydney Local Health District: collaborator

Study Sites (2)

Sydney and Sydney Eye Hospital

Sydney, New South Wales, 2000, Australia

Location

Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirsten Morley, PhD

CONTACT

+61295153636; kirsten.morley@sydney.edu.au

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: December 19, 2019
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: January 9, 2020

Record last verified: 2020-01

Locations

AU (2)