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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
Titles & IDs
Public title
The Efficacy and Neurobehavioural Mechanism of Cannabidiol (CBD) for Alcohol Dependence
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Scientific title
The Efficacy and Neurobehavioural Mechanism of Cannabidiol (CBD) for Alcohol Dependence: An Exploratory Pilot Study
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Secondary ID [1]
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X19-0416
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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 Use Disorder (AUD)
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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 (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.
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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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Changes in High Frequency Heart Rate Variability
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Assessment method [1]
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To assess whether acute ingestion of CBD can modulate heart rate variability when responding to alcohol cues compared to neutral cues
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Timepoint [1]
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22 days
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Primary outcome [2]
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Changes in Skin Conductance Levels
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Assessment method [2]
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To assess whether acute ingestion of CBD modulates skin conductance levels when responding to alcohol cues compared to neutral cues
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Timepoint [2]
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22 days
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Primary outcome [3]
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Changes in Brain Activation
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Assessment method [3]
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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
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Timepoint [3]
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22 days
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Primary outcome [4]
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Changes in Neurotransmitter levels in the Brain
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Assessment method [4]
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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)
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Timepoint [4]
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22 days
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Primary outcome [5]
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Heavy Drinking Days
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Assessment method [5]
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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.
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Timepoint [5]
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Up to 43 days
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Primary outcome [6]
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Absence of any Heavy Drinking Day
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Assessment method [6]
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Measured by Timeline Follow Back
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Timepoint [6]
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Up to 43 days
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Primary outcome [7]
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Mean Alcohol Consumption per Drinking Day
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Assessment method [7]
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Measured by Timeline Follow Back
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Timepoint [7]
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Up to 43 days
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Primary outcome [8]
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Alcohol Dependence Severity
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Assessment method [8]
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Measured by the Alcohol Dependence Scale. The minimum score is 0 and the maximum score is 47. A higher score indicates more severe dependence.
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Timepoint [8]
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Baseline
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Primary outcome [9]
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Alcohol Craving
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Assessment method [9]
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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.
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Timepoint [9]
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Up to 43 days
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Secondary outcome [1]
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Changes in Alcohol Craving
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Assessment method [1]
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To assess whether acute ingestion of CBD can modulate subjective measures of alcohol cue elicited craving. This will be measured during the fMRI scan using the Visual Analogue Scale. This scale will assess alcohol craving, thirst and anxiety.
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Timepoint [1]
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22 days
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Secondary outcome [2]
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Changes in Alcohol Craving in response to alcohol cues
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Assessment method [2]
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To assess whether acute ingestion of CBD can modulate subjective measures of alcohol cue elicited craving. This will be measured before and after the fMRI scan using the Alcohol Urge Questionnaire (AUQ). This Questionnaire consists of 8 questions that are scored on a Likert scale of 7 points. Two of the questions are reversed scored. Total score is computed by averaging the item scores. A greater score indicates greater craving.
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Timepoint [2]
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22 days
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Secondary outcome [3]
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Changes in Positive and Negative Mood States
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Assessment method [3]
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To assess whether acute ingestion of CBD can modulate subjective measures of positive and negative mood states following alcohol cues. This will be measured before and after the fMRI scan using the Positive and Negative Affect Schedule (PANAS).
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Timepoint [3]
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22 days
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Secondary outcome [4]
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Changes in Anxiety
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Assessment method [4]
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Measured by cumulative scores on the DASS-21 Anxiety Scale. This scale has a minimum score of 0 and maximum score of 21. A higher score indicates more anxiety.
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Timepoint [4]
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Up to 43 days
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Secondary outcome [5]
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Changes in Depression
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Assessment method [5]
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Measured by cumulative scores on the DASS-21 Depression Scale. This scale has a minimum score of 0 and maximum score of 21. A higher score indicates greater depression.
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Timepoint [5]
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Up to 43 days
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Secondary outcome [6]
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Changes in Stress
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Assessment method [6]
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Measured by cumulative scores on the DASS-21 Stress Scale. This scale has a minimum score of 0 and maximum score of 21. A higher score indicates more stress.
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Timepoint [6]
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Up to 43 days
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Secondary outcome [7]
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Sleep Disturbances
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Assessment method [7]
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As measured by the ISI (Insomnia Severity Index). This Index has a minimum score of 0 and a maximum score of 28. The higher the score indicates more severe insomnia.
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Timepoint [7]
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Up to 43 days
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Secondary outcome [8]
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Sleep Disturbances
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Assessment method [8]
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To assess whether acute ingestion of CBD has any impact of sleep. This will be measured by an Actiwatch. The Actiwatch records motion and light to determine information about participants sleep and wake patterns. The participants will wear this watch for 48 hours on two separate occasions.
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Timepoint [8]
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22 days
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Secondary outcome [9]
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Changes in Tension Reduction Alcohol Expectancies
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Assessment method [9]
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To assess whether CBD treatment can reduce participants need to use alcohol to attenuate tension states (such as anxiety) as measured by the Tension Reduction subscale of the Alcohol Expectancy Questionnaire. Higher scores indicate greater reliance on alcohol to reduce tension/ anxiety.
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Timepoint [9]
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Up to 43 days
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Secondary outcome [10]
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Lifetime Consequences related to Drinking
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Assessment method [10]
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To examine the adverse consequences a participant has experienced in their lifetime due to alcohol abuse in five areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. This is measured using the Drinker Inventory of Consequences Lifetime Edition (DrInC-2L). Higher scores indicate more consequences.
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Timepoint [10]
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Baseline
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Secondary outcome [11]
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Recent Consequences related to Drinking
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Assessment method [11]
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To examine the adverse consequences a participant has experienced in the last 3 months due to alcohol abuse in five areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. This is measured using the Drinker Inventory of Consequences Recent Edition (DrInC-2R). Higher scores indicate more consequences.
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Timepoint [11]
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Baseline
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Secondary outcome [12]
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Behavioural Inhibition/Avoidance Scales
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Assessment method [12]
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The BIS/BAS Scale is a 20-item self-report questionnaire designed to measure two motivational systems: the behavioral inhibition system (BIS), which corresponds to motivation to avoid aversive outcomes, and the behavioral activation system (BAS), which corresponds to motivation to approach goal-oriented outcomes.
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Timepoint [12]
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22 days
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Secondary outcome [13]
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Obsessive Compulsive Drinking
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Assessment method [13]
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To assess an individuals obsessive thoughts about alcohol use and compulsive behaviours towards drinking as measured by the Obsessive Compulsive Drinking Scale. Six of the questions measure to obsession and eight of the questions measure compulsivity. Higher scores on these subscales indicate more obsession and compulsion, respectively.
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Timepoint [13]
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22 days
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Secondary outcome [14]
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Self-Confidence to Remain Abstinent
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Assessment method [14]
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To measure an individual's self-confidence in avoiding alcohol through the Alcohol Abstinence Self-Efficacy Scale (AASE). There are 20 questions and each is scored from 0 to 4. Higher scores on this scale indicate more self-confidence.
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Timepoint [14]
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22 days
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Secondary outcome [15]
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Intolerance of Uncertainty
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Assessment method [15]
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To assess an individual's reactions to situations that are ambiguous, the consequences of being uncertain, and attempts the individual might make to control the future. This will be measured through the Intolerance of Uncertainty Scale (IUS). This scale includes 27-items that are scored on a Likert scale (1 - Not at all characteristic of me to 5 - entirely characteristic of me). All scores are summed up and a higher score indicates greater inability to deal with uncertainty.
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Timepoint [15]
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22 days
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Secondary outcome [16]
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Impulsivity
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Assessment method [16]
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To assess an individual's impulsivity across four domains: urgency, lack of premeditation and perseverance, and sensation seeking. This will be measured through the Impulsivity Scale (UPPS). Greater scores on this scale indicate greater impulsivity.
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Timepoint [16]
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22 days
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Secondary outcome [17]
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Alcohol Withdrawal
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Assessment method [17]
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To assess an individual's severity of alcohol withdrawal through the Clinical Institute Withdrawal Assessment of Alcohol Scale - Revised (CIWA-Ar). Greater scores on this scale indicate the participant is experiencing greater alcohol withdrawal symptoms.
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Timepoint [17]
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22 days
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Secondary outcome [18]
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Approach and Avoidance towards Alcohol
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Assessment method [18]
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To assess an individual's automatic action tendencies (either approve or avoid) towards alcohol. This will be measured through the Approach Avoidance Task (AAT).
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Timepoint [18]
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Up to 43 days
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Secondary outcome [19]
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Response Time and Visuospatial Skills
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Assessment method [19]
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To assess an individual's response time and visuospatial skills through the Trail Making Test Part A (TMT-A).
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Timepoint [19]
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Up to 43 days
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Secondary outcome [20]
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Set-shifting Flexibility, Attention, and Inhibition
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Assessment method [20]
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To assess an individual's set-shifting flexibility, attention and inhibition through the Trail Making Test Part B (TMT-B).
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Timepoint [20]
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Up to 43 days
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Secondary outcome [21]
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Risk/Reward Taking Behaviour
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Assessment method [21]
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To assess an individual's risk taking behaviour measured through the Balloon Analogue Risk Task (BART).
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Timepoint [21]
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Up to 43 days
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Secondary outcome [22]
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Decision Making
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Assessment method [22]
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To assess an individual's decision making skills measured through the Columbia Card Task (CCT).
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Timepoint [22]
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Up to 43 days
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Secondary outcome [23]
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Response Inhibition
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Assessment method [23]
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To assess an individual's ability to inhibit prepotent responses measured through the Stroop task.
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Timepoint [23]
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Up to 43 days
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Secondary outcome [24]
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Working Memory Capacity to Update Information
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Assessment method [24]
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To assess an individual's capacity to update working memory information measured through the N-back task.
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Timepoint [24]
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Up to 43 days
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Secondary outcome [25]
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Working Memory Capacity to Shift Information
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Assessment method [25]
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To assess an individual's capacity to shift between two tasks measured by the Number Letter task.
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Timepoint [25]
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Up to 43 days
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Secondary outcome [26]
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Markers of neuroinflammation
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Assessment method [26]
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As measured by differences in blood sampling levels of glutathione.
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Timepoint [26]
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Up to 43 days
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Secondary outcome [27]
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Markers of Stress
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Assessment method [27]
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As measured by differences in blood sampling levels of cortisol. This will be measured at rest, before the fMRI scan and following the fMRI scan.
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Timepoint [27]
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Up to 43 days
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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
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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
* 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.
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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 analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 2
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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
1/06/2022
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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
1/06/2024
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Actual
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Sample size
Target
20
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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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Drug Health Services, Royal Prince Alfred Hospital - Sydney
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Recruitment postcode(s) [1]
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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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Other
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Name [2]
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Lambert Initiative for Cannabinoid Therapeutics
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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
The study will explore the psychophysiological and neurobiological and mechanisms of CBD in participants with alcohol use disorder
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Trial website
https://clinicaltrials.gov/study/NCT05387148
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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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Address
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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
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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/NCT05387148