Trial · NCT06845124
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Obsessive Compulsive Drinking Scale (OCDS-G) | The difference of alcohol craving between baseline (visit 2) and 14 days after the first treatment visit (visit 5) will serve as primary endpoint. | The alcohol craving will be assessed at separate time points before and after Cannabidiol administration using the Obsessive Compulsive Drinking Scale. The Obsessive Compulsive Drinking Scale consists of 14 items, each rated on a 5-point Likert scale (0-4), resulting in scores from 0 to 40, with higher scores indicating higher craving. |
| Secondary | Obsessive Compulsive Drinking Scale (OCDS-G) | Differences from baseline (visit 2, day -2) of Obsessive Compulsive Drinking Scale craving scores to visits 4 (day 7, i.e., 7 days after the first treatment visit) and during follow up visits 6 (day 28), 7 (day 42), 8 (day 105), 9 (day 196) | The alcohol craving will be assessed at separate time points before and after Cannabidiol administration using the Obsessive Compulsive Drinking Scale. The Obsessive Compulsive Drinking Scale consists of 14 items, each rated on a 5-point Likert scale (0-4), resulting in scores from 0 to 40, with higher scores indicating higher craving. |
| Secondary | Subjective quality of life index | Differences from baseline (visit 2, day -2) of Quality of life (WHO-QOL-BREF scores) to end of treatment (visit 5, day 14) and follow up visits 6 (day 28), 7 (day 42), 8 (day 105), 9 (day 196). | Quality of life will be assessed using the World Health Organization Quality of life questionnaire (WHO-QOL-BREF) scores at separate time points before and after Cannabidiol administration. The World Health Organization Quality of life questionnaire is an instrument that can assess patients' global health status independently of disease across 4 health domains and consists of 26 items rated on a 5-point Likert scale (1-5). To calculate the score, items 3, 4, 26 have to be inverted. Scores for each domain (Physical Health, Psychological Health, Social Relationships, Environment) are calculated, that range from 4 to 20. Higher scores indicate better quality of life, with the overall score reflecting a person's general well-being. |
| Secondary | Beck Depression Inventory (BDI-II) | Difference from baseline (visit 2, day -2) of depressive symptoms to end of treatment (visit 5, day 14) | The depressive symptoms will be assessed at separate time points before and after Cannabidiol administration using the Beck Depression Inventory (BDI-II). The Beck Depression Inventory (BDI-II) is a 21-item self-rating inventory that measures characteristic attitudes and symptoms of depression. Each Item is rated on a 4-point Likert scale (0-3). The total score ranges from 0 to 63, with higher scores indicating more severe depressive symptoms. |
| Secondary | State Trait Anxiety Inventory (STAI) | Difference from baseline (visit 2, day -2) of depressive symptoms to end of treatment (visit 5, day 14) | The state and trait anxiety will be assessed at separate time points before and after Cannabidiol administration using the State Trait Anxiety Inventory. The State Trait Anxiety Inventory (STAI) is a 20-item self-report questionnaire that assesses state anxiety and trait anxiety via two subscales: the State Anxiety Scale (STAI-S) and the Trait Anxiety Scale (STAI-T), each consisting of 20 items. Each item is rated on a 4-point Likert scale (1-4). A sumscore has to be calculated for each subscale, ranging from 20 to 80 each, with higher scores indicating higher levels of anxiety. |
| Secondary | Patient reported outcomes (PRO) | On visit 3 (day 1 of treatment), visit 4 (day 7 of treatment), visit 5 (day 14, end of treatment) and during follow up visits 6 (day 28), 7 (day 42), 8 (day 105), 9 (day 196) | The patient reported outcomes will be assessed at separate time points before and after Cannabidiol administration using a set of items assessing effects of the treatment as well as treatment burden on a five-point Likert scale (0 to 4) with higher values indicating more positive effects. |
| Secondary | CBD plasma levels | On visit 3 (day 1 of treatment) and visit 5 (day 14, end of treatment) | The CBD plasma levels will be determined at separate time points before and after Cannabidiol administration to detect effects of active intervention on blood plasma levels. (Only participants enrolled at CIMH study site). |
| Secondary | Adverse Events (AEs) and Serious Adverse Events (SAEs) | On visit 3 (day 1 of treatment), visit 4 (day 7 of treatment), visit 5 (day 14, end of treatment) and during follow up visits 6 (day 28), 7 (day 42), 8 (day 105), 9 (day 196) | Rate of adverse events and serious adverse events. |
| Secondary | Time to relapse | On visit 5 (day 14, end of treatment) and during follow up visits 6 (day 28), 7 (day 42), 8 (day 105), 9 (day 196) | Time from baseline (visit 2, day -2) to relapse to alcohol use (i.e. any alcohol use) (in days), assessed using the Form-90 semi-structured interview (Timeline Follow Back). |
| Secondary | Cumulative alcohol consumption during the follow-up period | On visit 5 (day 14, end of treatment) and during follow up visits 6 (day 28), 7 (day 42), 8 (day 105), 9 (day 196) | Cumulative alcohol consumption (in grams alcohol) during the follow-up period of 182 days (+/- 7 days), assessed using the Form-90 semi-structured interview (Timeline Follow Back). |
| Secondary | Percent heavy drinking days during the follow-up period | On visit 5 (day 14, end of treatment) and during follow up visits 6 (day 28), 7 (day 42), 8 (day 105), 9 (day 196) | Percent heavy drinking days during the follow-up period of 182 days (+/- 7 days), assessed using the Form-90 semi-structured interview (Timeline Follow Back). |
| Secondary | Average weekly alcohol consumption during the follow-up period | Every 7 days during the follow-up period of 182 days (+/- 7 days), starting after visit 5, i.e., end of treatment (day 14) and continuing until visit 9, i.e., end of follow up (day 196) | Average weekly alcohol consumption assessed via smartphone-based e-diary every 7 days during the follow-up period of 182 days (+/- 7 days) (optional, only for patients that agree to use the study-specific app). |
| Secondary | Maximum weekly craving during the follow-up period | Every 7 days during the follow-up period of 182 days (+/- 7 days), starting after visit 5, i.e., end of treatment (day 14) and continuing until visit 9, i.e., end of follow up (day 196) | Maximum weekly craving assessed via smartphone-based e-diary every 7 days during the follow-up period of 182 days (+/- 7 days) (optional, only for patients that agree to use the study-specific app). |
| Secondary | Neural Brain Activation during functional magnetic resonance imaging | Differences from baseline (visit 2, day -2) to visit 5 (day 14, end of treatment) | Differences from baseline of neural brain activation to visit 5, measured using the blood oxygenated level dependent (BOLD) response, during presentation of alcohol cues, during the presentation of natural reward cues, during inhibition of motor responses, during presentation of emotional faces and neutral shapes and functional connectivity during resting state (only for patients enrolled at CIMH study site). |
| Secondary | Alcohol Craving during functional magnetic resonance imaging | Differences from baseline (visit 2, day -2) to visit 5 (day 14, end of treatment) | Differences from baseline of alcohol craving (visual analogue scale) during the functional magnetic resonance imaging (fMRI) to visit 5 (only for patients enrolled at CIMH study site). |
| Secondary | Response Times during functional magnetic resonance imaging | Differences from baseline (visit 2, day -2) to visit 5 (day 14, end of treatment) | Differences in response times (i.e., time taken to respond) during functional magnetic resonance imaging (fMRI) from baseline to visit 5 (only for patients enrolled at CIMH study site). |
| Secondary | Rates of Errors during functional magnetic resonance imaging | Differences from baseline (visit 2, day -2) to visit 5 (day 14, end of treatment) | Differences in rates of errors during functional magnetic resonance imaging (fMRI) from baseline to visit 5 (only for patients enrolled at CIMH study site) |
| Secondary | Rates of Correct Responses during functional magnetic resonance imaging | Differences from baseline (visit 2, day -2) to visit 5 (day 14, end of treatment) | Differences in rates of correct responses during functional magnetic resonance imaging (fMRI) from baseline to visit 5 (only for patients enrolled at CIMH study site) |
| Secondary | Omission Rates during functional magnetic resonance imaging | Differences from baseline (visit 2, day -2) to visit 5 (day 14, end of treatment) | Differences in omission rates (i.e., rate of failure to respond when a response is expected) during functional magnetic resonance imaging (fMRI) from baseline to visit 5 (only for patients enrolled at CIMH study site) |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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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