Trial · NCT05387148
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 36
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in High Frequency Heart Rate Variability | 22 days | To assess whether acute ingestion of CBD can modulate heart rate variability when responding to alcohol cues compared to neutral cues |
| Primary | Changes in Skin Conductance Levels | 22 days | To assess whether acute ingestion of CBD modulates skin conductance levels when responding to alcohol cues compared to neutral cues |
| Primary | Changes in Brain Activation | 22 days | 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 |
| Primary | Changes in Neurotransmitter levels in the Brain | 22 days | 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) |
| Primary | Heavy Drinking Days | Up to 43 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. |
| Primary | Absence of any Heavy Drinking Day | Up to 43 days | Measured by Timeline Follow Back |
| Primary | Mean Alcohol Consumption per Drinking Day | Up to 43 days | Measured by Timeline Follow Back |
| Primary | Alcohol Dependence Severity | Baseline | Measured by the Alcohol Dependence Scale. The minimum score is 0 and the maximum score is 47. A higher score indicates more severe dependence. |
| Primary | Alcohol Craving | Up to 43 days | 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. |
| Secondary | Changes in Alcohol Craving | 22 days | 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. |
| Secondary | Changes in Alcohol Craving in response to alcohol cues | 22 days | 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. |
| Secondary | Changes in Positive and Negative Mood States | 22 days | 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). |
| Secondary | Changes in Anxiety | Up to 43 days | 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. |
| Secondary | Changes in Depression | Up to 43 days | 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. |
| Secondary | Changes in Stress | Up to 43 days | 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. |
| Secondary | Sleep Disturbances | Up to 43 days | 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. |
| Secondary | Sleep Disturbances | 22 days | 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. |
| Secondary | Changes in Tension Reduction Alcohol Expectancies | Up to 43 days | 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. |
| Secondary | Lifetime Consequences related to Drinking | Baseline | 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. |
| Secondary | Recent Consequences related to Drinking | Baseline | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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