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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05387148




Registration number
NCT05387148
Ethics application status
Date submitted
15/05/2022
Date registered
24/05/2022
Date last updated
3/06/2022

Titles & IDs
Public title
The Efficacy and Neurobehavioural Mechanism of Cannabidiol (CBD) for Alcohol Dependence
Scientific title
The Efficacy and Neurobehavioural Mechanism of Cannabidiol (CBD) for Alcohol Dependence: An Exploratory Pilot Study
Secondary ID [1] 0 0
X19-0416
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol Use Disorder (AUD) 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 (CBD)
Treatment: Drugs - Placebo

Experimental: Cannabidiol (CBD) - For a total of three days, so that both study participants and staff are blind to treatment condition

Placebo comparator: Placebo - For a total of three days, so that both study participants and staff are blind to treatment condition


Treatment: Drugs: Cannabidiol (CBD)
Four 200mg soft gel capsules of Cannabidiol (CBD) will be taken orally daily for a total of 3 days.

Treatment: Drugs: Placebo
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes in High Frequency Heart Rate Variability
Timepoint [1] 0 0
22 days
Primary outcome [2] 0 0
Changes in Skin Conductance Levels
Timepoint [2] 0 0
22 days
Primary outcome [3] 0 0
Changes in Brain Activation
Timepoint [3] 0 0
22 days
Primary outcome [4] 0 0
Changes in Neurotransmitter levels in the Brain
Timepoint [4] 0 0
22 days
Primary outcome [5] 0 0
Heavy Drinking Days
Timepoint [5] 0 0
Up to 43 days
Primary outcome [6] 0 0
Absence of any Heavy Drinking Day
Timepoint [6] 0 0
Up to 43 days
Primary outcome [7] 0 0
Mean Alcohol Consumption per Drinking Day
Timepoint [7] 0 0
Up to 43 days
Primary outcome [8] 0 0
Alcohol Dependence Severity
Timepoint [8] 0 0
Baseline
Primary outcome [9] 0 0
Alcohol Craving
Timepoint [9] 0 0
Up to 43 days
Secondary outcome [1] 0 0
Changes in Alcohol Craving
Timepoint [1] 0 0
22 days
Secondary outcome [2] 0 0
Changes in Alcohol Craving in response to alcohol cues
Timepoint [2] 0 0
22 days
Secondary outcome [3] 0 0
Changes in Positive and Negative Mood States
Timepoint [3] 0 0
22 days
Secondary outcome [4] 0 0
Changes in Anxiety
Timepoint [4] 0 0
Up to 43 days
Secondary outcome [5] 0 0
Changes in Depression
Timepoint [5] 0 0
Up to 43 days
Secondary outcome [6] 0 0
Changes in Stress
Timepoint [6] 0 0
Up to 43 days
Secondary outcome [7] 0 0
Sleep Disturbances
Timepoint [7] 0 0
Up to 43 days
Secondary outcome [8] 0 0
Sleep Disturbances
Timepoint [8] 0 0
22 days
Secondary outcome [9] 0 0
Changes in Tension Reduction Alcohol Expectancies
Timepoint [9] 0 0
Up to 43 days
Secondary outcome [10] 0 0
Lifetime Consequences related to Drinking
Timepoint [10] 0 0
Baseline
Secondary outcome [11] 0 0
Recent Consequences related to Drinking
Timepoint [11] 0 0
Baseline
Secondary outcome [12] 0 0
Behavioural Inhibition/Avoidance Scales
Timepoint [12] 0 0
22 days
Secondary outcome [13] 0 0
Obsessive Compulsive Drinking
Timepoint [13] 0 0
22 days
Secondary outcome [14] 0 0
Self-Confidence to Remain Abstinent
Timepoint [14] 0 0
22 days
Secondary outcome [15] 0 0
Intolerance of Uncertainty
Timepoint [15] 0 0
22 days
Secondary outcome [16] 0 0
Impulsivity
Timepoint [16] 0 0
22 days
Secondary outcome [17] 0 0
Alcohol Withdrawal
Timepoint [17] 0 0
22 days
Secondary outcome [18] 0 0
Approach and Avoidance towards Alcohol
Timepoint [18] 0 0
Up to 43 days
Secondary outcome [19] 0 0
Response Time and Visuospatial Skills
Timepoint [19] 0 0
Up to 43 days
Secondary outcome [20] 0 0
Set-shifting Flexibility, Attention, and Inhibition
Timepoint [20] 0 0
Up to 43 days
Secondary outcome [21] 0 0
Risk/Reward Taking Behaviour
Timepoint [21] 0 0
Up to 43 days
Secondary outcome [22] 0 0
Decision Making
Timepoint [22] 0 0
Up to 43 days
Secondary outcome [23] 0 0
Response Inhibition
Timepoint [23] 0 0
Up to 43 days
Secondary outcome [24] 0 0
Working Memory Capacity to Update Information
Timepoint [24] 0 0
Up to 43 days
Secondary outcome [25] 0 0
Working Memory Capacity to Shift Information
Timepoint [25] 0 0
Up to 43 days
Secondary outcome [26] 0 0
Markers of neuroinflammation
Timepoint [26] 0 0
Up to 43 days
Secondary outcome [27] 0 0
Markers of Stress
Timepoint [27] 0 0
Up to 43 days

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

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 analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/06/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2024
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Drug Health Services, Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 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
Lambert Initiative for Cannabinoid Therapeutics
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The study will explore the psychophysiological and neurobiological and mechanisms of CBD in participants with alcohol use disorder
Trial website
https://clinicaltrials.gov/study/NCT05387148
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/study/NCT05387148