The Efficacy and Neurobehavioural Mechanism of Cannabidiol (CBD) for Alcohol Dependence
1 other identifier
interventional
20
1 country
1
Brief Summary
The study will explore the psychophysiological and neurobiological and mechanisms of CBD in participants with alcohol use disorder
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2022
CompletedFirst Posted
Study publicly available on registry
May 24, 2022
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedJune 3, 2022
May 1, 2022
1 year
May 15, 2022
May 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Changes in High Frequency Heart Rate Variability
To assess whether acute ingestion of CBD can modulate heart rate variability when responding to alcohol cues compared to neutral cues
22 days
Changes in Skin Conductance Levels
To assess whether acute ingestion of CBD modulates skin conductance levels when responding to alcohol cues compared to neutral cues
22 days
Changes in Brain Activation
To assess whether acute ingestion of CBD can attenuate brain activation via blood oxygen level dependent (BOLD) in areas associated with alcohol cue-elicited craving measured by an fMRI machine
22 days
Changes in Neurotransmitter levels in the Brain
To assess whether CBD treatment leads to changes in brain levels of the neurotransmitters: glutamate, gamma-aminobutyric acid (GABA), N-acetylaspartate (NAA) and glutathione (GSH)
22 days
Heavy Drinking Days
Reduction in Heavy Drinking Days (HDD; defined as 4 or more drinks in a day for women and five or more drinks in a day for men). This will be measured by the Timeline Follow Back.
Up to 43 days
Absence of any Heavy Drinking Day
Measured by Timeline Follow Back
Up to 43 days
Mean Alcohol Consumption per Drinking Day
Measured by Timeline Follow Back
Up to 43 days
Alcohol Dependence Severity
Measured by the Alcohol Dependence Scale. The minimum score is 0 and the maximum score is 47. A higher score indicates more severe dependence.
Baseline
Alcohol Craving
As measured by the Penn Alcohol Craving Scale (PACS), which measures the amount of time spent thinking and craving for alcohol, difficulty in resisting consumption of alcohol if present and hypothetical pleasure associated with consumption of alcohol. This scale has a minimum score of 0 and a maximum score of 6. A higher score indicates greater levels of craving.
Up to 43 days
Secondary Outcomes (27)
Changes in Alcohol Craving
22 days
Changes in Alcohol Craving in response to alcohol cues
22 days
Changes in Positive and Negative Mood States
22 days
Changes in Anxiety
Up to 43 days
Changes in Depression
Up to 43 days
- +22 more secondary outcomes
Study Arms (2)
Cannabidiol (CBD)
EXPERIMENTALFor a total of three days, so that both study participants and staff are blind to treatment condition
Placebo
PLACEBO COMPARATORFor a total of three days, so that both study participants and staff are blind to treatment condition
Interventions
Four 200mg soft gel capsules of Cannabidiol (CBD) will be taken orally daily for a total of 3 days.
The placebo will be identical in appearance, taste, and composition except for the active ingredient of pure CBD. So, four 200mg soft gel capsules of the placebo will be taken orally daily for a total of 3 days.
Eligibility Criteria
You may qualify if:
- Male and female patients between ages of 18 and 65 meeting DSM-5 criteria for current alcohol use disorder
- Adequate cognition and English language skills to give valid consent and complete research interviews;
- A BrAC reading of 0.00
- Must have a stable residence and be able to identify an individual who could locate subject if needed
- Provision of informed consent
You may not qualify if:
- Active major psychological disorder associated with psychosis, significant suicide risk
- 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;
- Dependence on any substance other than nicotine (eg methadone)
- Diagnosis of epilepsy, and/or current use of anti-epileptic drugs (AED)
- Liver failure with jaundice or prolonged INR above 1.3
- Medical complications such as liver failure, cardiac ischemia or conduction abnormalities, renal impairment or unstable elevated vital signs (systolic blood pressure \> 180, diastolic blood pressure \> 120 or heart rate \> 150)
- Severe cognitive impairment or insufficient English or literacy to complete study processes
- Concurrent use of drugs potentially exacerbated by CBD via CYP3A5 including cardiac medication (e.g. betablockers, calcium channel blockers and statins), macrolides and recent antihistamine use.
- Claustrophobia;
- Extreme obesity;
- Previous brain surgery;
- Ever employed as a machinist, a welder or a metal worker;
- Metal items such as pacemakers; aneurysm clips in the brain; metal dental implants; metallic fragments in the eye or anywhere else; insulin pump; metal implants; hearing aid or a prosthetic device.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- South West Sydney Local Health Districtlead
- University of Sydneycollaborator
- Lambert Initiative for Cannabinoid Therapeuticscollaborator
Study Sites (1)
Drug Health Services, Royal Prince Alfred Hospital
Sydney, New South Wales, 2050, Australia
Related Publications (1)
Hurzeler TP, Logge W, Watt J, DeMayo MM, Suraev A, McGregor IS, Haber PS, Morley KC. The neurobehavioural effects of cannabidiol in alcohol use disorder: Study protocol for a double-blind, randomised, cross over, placebo-controlled trial. Contemp Clin Trials Commun. 2024 Aug 13;41:101341. doi: 10.1016/j.conctc.2024.101341. eCollection 2024 Oct.
PMID: 39252861DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-blind
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor Kirsten Morley
Study Record Dates
First Submitted
May 15, 2022
First Posted
May 24, 2022
Study Start
June 1, 2022
Primary Completion
June 1, 2023
Study Completion
June 1, 2024
Last Updated
June 3, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share