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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Tilray | INDUSTRY |
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The goal of the proposed project is to begin rigorous study of the clinically relevant effects of non-psychoactive phytocannabinoid cannabidiol (CBD) in patients with severe alcohol use disorder (AUD). This double-blind, randomized proof-of-concept study (n = 40) is designed to assess feasibility and contrast effects of extended (8 weeks) treatment with CBD to those of placebo in AUD patients. Participants with AUD will be randomized to receive either placebo or 600mg CBD/day (PO) for 4 weeks, immediately followed by 1200mg CBD/day (PO) for an additional 4 weeks (8 total weeks). These doses were chosen to reproduce serum CBD levels reported to reduce alcohol-seeking behavior in animal studies. Measures will include circulating levels of CBD, safety measures (THC serum levels, adverse events, cognitive and motoric function), and physiological and psychological domains relevant to AUD (including self-reported craving, depression, and anxiety, and responses to personalized scripts designed to elicit stress- and cue-induced craving and anxiety). Assessments will be conducted following 1 day, 1 week, and 4 weeks of treatment with each dose of CBD vs. placebo, and 1 and 4 weeks after the cessation of treatment. Drinking outcomes across 8 weeks of treatment and 4 weeks of follow-up will also be assessed as an exploratory outcome.
There is increasing recognition of the roles of the endocannabinoid system in neurobiological processes and behavioral domains relevant to addiction. The non-psychoactive phytocannabinoid cannabidiol (CBD) has attracted considerable attention due to its lack of abuse potential, its excellent safety profile, its unique and complex pharmacology, and evidence that it affects anxiety and stress response in animal models and humans. There is a growing body of preclinical data demonstrating that CBD produces marked and persisting decreases in alcohol self-administration and preference for alcohol, and alcohol-, cue- and stress-induced reinstatement of alcohol-seeking behavior, yet there are few studies of the effects of CBD in humans with addictive disorders, and none in alcohol dependent patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo for 4 weeks, followed by phytocannabinoid cannabidiol (CBD) for 4 weeks | Experimental | 600mg/day Saline taken by mouth (PO) for 4 weeks, immediately followed by 1200mg saline/ day (PO) for an additional 4 weeks (8 total weeks). |
|
| CBD for 8 weeks | Experimental | 600mg CBD/day (PO) for 4 weeks, immediately followed by 1200mg CBD/day (PO) for an additional 4 weeks (8 total weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Saline taken by mouth (PO) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trough CBD Plasma Levels | CBD "trough" plasma levels measured before dosing with CBD. | Baseline |
| Trough CBD Plasma Levels | CBD "trough" plasma levels measured before dosing with CBD. | Week 1 |
| Trough CBD Plasma Levels | CBD "trough" plasma levels measured before dosing with CBD. | Week 4 |
| Trough CBD Plasma Levels | CBD "trough" plasma levels measured before dosing with CBD. | Week 5 |
| Trough CBD Plasma Levels | CBD "trough" plasma levels measured before dosing with CBD. | Week 8 |
| Trough CBD Plasma Levels | CBD "trough" plasma levels measured before dosing with CBD. | Week 9 |
| Peak CBD Plasma Levels | CBD "peak" plasma levels measured 45 minutes after dosing with CBD. | Baseline |
| Peak CBD Plasma Levels | CBD "peak" plasma levels measured 45 minutes after dosing with CBD. | Day 1 |
| Peak CBD Plasma Levels |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Heavy Drinking Days | The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. | Baseline |
| Percent of Heavy Drinking Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Bogenschutz, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 3 months and ending 5 years following article publication.
Researchers who provide a methodologically sound proposal with have access to the data. To gain access, data requestors will need to sign a data access agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | 600mg Saline/Day for 4 Weeks, Then 1200mg Saline/Day for 4 Weeks | 600mg Saline/ day (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks). |
| FG001 | 600mg CBD/Day for 4 Weeks, Then 1200mg CBD/Day for 4 Weeks | 600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 600mg Saline/Day for 4 Weeks, Then 1200mg Saline/Day for 4 Weeks | 600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks). |
| BG001 | 600mg CBD/Day for 4 Weeks, Then 1200mg CBD/Day for 4 Weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Trough CBD Plasma Levels | CBD "trough" plasma levels measured before dosing with CBD. | Posted | Median | Standard Deviation | CBD (ng/mL) | Baseline |
|
12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for Ketoacidosis | Metabolism and nutrition disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Bogenschutz, PhD | NYU Langone Health | 646-501-4026 | Michael.Bogenschutz@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2021 | Mar 16, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Double-blind, randomized proof-of-concept study
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| Phytocannabinoid cannabidiol (CBD) | Drug | CBD taken by mouth (PO) |
|
CBD "peak" plasma levels measured 45 minutes after dosing with CBD. |
| Week 1 |
| Peak CBD Plasma Levels | CBD "peak" plasma levels measured 45 minutes after dosing with CBD. | Week 4 |
| Peak CBD Plasma Levels | CBD "peak" plasma levels measured 45 minutes after dosing with CBD. | Week 4 + 1 Day |
| Peak CBD Plasma Levels | CBD "peak" plasma levels measured 45 minutes after dosing with CBD. | Week 5 |
| Peak CBD Plasma Levels | CBD "peak" plasma levels measured 45 minutes after dosing with CBD. | Week 8 |
The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. |
| Week 1 |
| Percent of Heavy Drinking Days | The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. | Week 2 |
| Percent of Heavy Drinking Days | The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. | Week 3 |
| Percent of Heavy Drinking Days | The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. | Week 4 |
| Percent of Heavy Drinking Days | The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. | Week 5 |
| Percent of Heavy Drinking Days | The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. | Week 6 |
| Percent of Heavy Drinking Days | The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. | Week 7 |
| Percent of Heavy Drinking Days | The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. | Week 8 |
| Percent of Heavy Drinking Days | The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. | Week 9 |
| Number of Drinks Per Day | The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. | Baseline |
| Number of Drinks Per Day | The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. | Week 1 |
| Number of Drinks Per Day | The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. | Week 2 |
| Number of Drinks Per Day | The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. | Week 3 |
| Number of Drinks Per Day | The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. | Week 4 |
| Number of Drinks Per Day | The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. | Week 5 |
| Number of Drinks Per Day | The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. | Week 6 |
| Number of Drinks Per Day | The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. | Week 7 |
| Number of Drinks Per Day | The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. | Week 8 |
| Number of Drinks Per Day | The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. | Week 9 |
| Penn Alcohol Craving Scale (PACS) Score | 5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving. | Baseline |
| Penn Alcohol Craving Scale (PACS) Score | 5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving. | Week 1 |
| Penn Alcohol Craving Scale (PACS) Score | 5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving. | Week 4 |
| Penn Alcohol Craving Scale (PACS) Score | 5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving. | Week 5 |
| Penn Alcohol Craving Scale (PACS) Score | 5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving. | Week 8 |
| Penn Alcohol Craving Scale (PACS) Score | 5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving. | Week 9 |
| Beck Anxiety Inventory (BAI) Score | 21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety. | Baseline |
| Beck Anxiety Inventory (BAI) Score | 21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety. | Week 1 |
| Beck Anxiety Inventory (BAI) Score | 21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety. | Week 4 |
| Beck Anxiety Inventory (BAI) Score | 21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety. | Week 5 |
| Beck Anxiety Inventory (BAI) Score | 21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety. | Week 8 |
| Beck Anxiety Inventory (BAI) Score | 21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety. | Week 9 |
| Beck Depression Inventory (BDI) Score | 21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression. | Baseline |
| Beck Depression Inventory (BDI) Score | 21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression. | Week 1 |
| Beck Depression Inventory (BDI) Score | 21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression. | Week 4 |
| Beck Depression Inventory (BDI) Score | 21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression. | Week 5 |
| Beck Depression Inventory (BDI) Score | 21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression. | Week 8 |
| Beck Depression Inventory (BDI) Score | 21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression. | Week 9 |
| Study Drug Expiration |
|
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Trough CBD Plasma Levels | CBD "trough" plasma levels measured before dosing with CBD. | Posted | Median | Standard Deviation | CBD (ng/mL) | Week 1 |
|
|
|
| Primary | Trough CBD Plasma Levels | CBD "trough" plasma levels measured before dosing with CBD. | Posted | Median | Standard Deviation | CBD (ng/mL) | Week 4 |
|
|
|
| Primary | Trough CBD Plasma Levels | CBD "trough" plasma levels measured before dosing with CBD. | Posted | Median | Standard Deviation | CBD (ng/mL) | Week 5 |
|
|
|
| Primary | Trough CBD Plasma Levels | CBD "trough" plasma levels measured before dosing with CBD. | Posted | Median | Standard Deviation | CBD (ng/mL) | Week 8 |
|
|
|
| Primary | Trough CBD Plasma Levels | CBD "trough" plasma levels measured before dosing with CBD. | Posted | Median | Standard Deviation | CBD (ng/mL) | Week 9 |
|
|
|
| Primary | Peak CBD Plasma Levels | CBD "peak" plasma levels measured 45 minutes after dosing with CBD. | Posted | Median | Standard Deviation | CBD (ng/mL) | Baseline |
|
|
|
| Primary | Peak CBD Plasma Levels | CBD "peak" plasma levels measured 45 minutes after dosing with CBD. | Posted | Median | Standard Deviation | CBD (ng/mL) | Day 1 |
|
|
|
| Primary | Peak CBD Plasma Levels | CBD "peak" plasma levels measured 45 minutes after dosing with CBD. | Posted | Median | Standard Deviation | CBD (ng/mL) | Week 1 |
|
|
|
| Primary | Peak CBD Plasma Levels | CBD "peak" plasma levels measured 45 minutes after dosing with CBD. | Posted | Median | Standard Deviation | CBD (ng/mL) | Week 4 |
|
|
|
| Primary | Peak CBD Plasma Levels | CBD "peak" plasma levels measured 45 minutes after dosing with CBD. | Posted | Median | Standard Deviation | CBD (ng/mL) | Week 4 + 1 Day |
|
|
|
| Primary | Peak CBD Plasma Levels | CBD "peak" plasma levels measured 45 minutes after dosing with CBD. | Posted | Median | Standard Deviation | CBD (ng/mL) | Week 5 |
|
|
|
| Primary | Peak CBD Plasma Levels | CBD "peak" plasma levels measured 45 minutes after dosing with CBD. | Posted | Median | Standard Deviation | CBD (ng/mL) | Week 8 |
|
|
|
| Secondary | Percentage of Heavy Drinking Days | The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. | Posted | Mean | Standard Deviation | percentage of days | Baseline |
|
|
|
| Secondary | Percent of Heavy Drinking Days | The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. | Posted | Median | Standard Deviation | percentage of days | Week 1 |
|
|
|
| Secondary | Percent of Heavy Drinking Days | The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. | Posted | Median | Standard Deviation | percentage of days | Week 2 |
|
|
|
| Secondary | Percent of Heavy Drinking Days | The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. | Posted | Median | Standard Deviation | percentage of days | Week 3 |
|
|
|
| Secondary | Percent of Heavy Drinking Days | The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. | Posted | Median | Standard Deviation | percentage of days | Week 4 |
|
|
|
| Secondary | Percent of Heavy Drinking Days | The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. | Posted | Median | Standard Deviation | percentage of days | Week 5 |
|
|
|
| Secondary | Percent of Heavy Drinking Days | The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. | Posted | Median | Standard Deviation | percentage of days | Week 6 |
|
|
|
| Secondary | Percent of Heavy Drinking Days | The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. | Posted | Median | Standard Deviation | percentage of days | Week 7 |
|
|
|
| Secondary | Percent of Heavy Drinking Days | The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. | Posted | Median | Standard Deviation | percentage of days | Week 8 |
|
|
|
| Secondary | Percent of Heavy Drinking Days | The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. | Posted | Median | Standard Deviation | percentage of days | Week 9 |
|
|
|
| Secondary | Number of Drinks Per Day | The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. | Posted | Median | Standard Deviation | Drinks per day | Baseline |
|
|
|
| Secondary | Number of Drinks Per Day | The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. | Posted | Median | Standard Deviation | drinks per day | Week 1 |
|
|
|
| Secondary | Number of Drinks Per Day | The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. | Posted | Median | Standard Deviation | drinks per day | Week 2 |
|
|
|
| Secondary | Number of Drinks Per Day | The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. | Posted | Median | Standard Deviation | drinks per day | Week 3 |
|
|
|
| Secondary | Number of Drinks Per Day | The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. | Posted | Median | Standard Deviation | drinks per day | Week 4 |
|
|
|
| Secondary | Number of Drinks Per Day | The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. | Posted | Median | Standard Deviation | drinks per day | Week 5 |
|
|
|
| Secondary | Number of Drinks Per Day | The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. | Posted | Median | Standard Deviation | drinks per day | Week 6 |
|
|
|
| Secondary | Number of Drinks Per Day | The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. | Posted | Median | Standard Deviation | drinks per day | Week 7 |
|
|
|
| Secondary | Number of Drinks Per Day | The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. | Posted | Median | Standard Deviation | drinks per day | Week 8 |
|
|
|
| Secondary | Number of Drinks Per Day | The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. | Posted | Median | Standard Deviation | drinks per day | Week 9 |
|
|
|
| Secondary | Penn Alcohol Craving Scale (PACS) Score | 5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving. | Posted | Median | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | Penn Alcohol Craving Scale (PACS) Score | 5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving. | Posted | Median | Standard Deviation | score on a scale | Week 1 |
|
|
|
| Secondary | Penn Alcohol Craving Scale (PACS) Score | 5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving. | Posted | Median | Standard Deviation | score on a scale | Week 4 |
|
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| Secondary | Penn Alcohol Craving Scale (PACS) Score | 5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving. | Posted | Median | Standard Deviation | score on a scale | Week 5 |
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| Secondary | Penn Alcohol Craving Scale (PACS) Score | 5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving. | Posted | Median | Standard Deviation | score on a scale | Week 8 |
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| Secondary | Penn Alcohol Craving Scale (PACS) Score | 5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving. | Posted | Median | Standard Deviation | score on a scale | Week 9 |
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| Secondary | Beck Anxiety Inventory (BAI) Score | 21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety. | Posted | Median | Standard Deviation | score on a scale | Baseline |
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| Secondary | Beck Anxiety Inventory (BAI) Score | 21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety. | Posted | Median | Standard Deviation | score on a scale | Week 1 |
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| Secondary | Beck Anxiety Inventory (BAI) Score | 21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety. | Posted | Median | Standard Deviation | score on a scale | Week 4 |
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| Secondary | Beck Anxiety Inventory (BAI) Score | 21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety. | Posted | Median | Standard Deviation | score on a scale | Week 5 |
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| Secondary | Beck Anxiety Inventory (BAI) Score | 21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety. | Posted | Median | Standard Deviation | score on a scale | Week 8 |
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| Secondary | Beck Anxiety Inventory (BAI) Score | 21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety. | Posted | Median | Standard Deviation | score on a scale | Week 9 |
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| Secondary | Beck Depression Inventory (BDI) Score | 21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression. | Posted | Median | Standard Deviation | score on a scale | Baseline |
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| Secondary | Beck Depression Inventory (BDI) Score | 21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression. | Posted | Median | Standard Deviation | score on a scale | Week 1 |
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| Secondary | Beck Depression Inventory (BDI) Score | 21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression. | Posted | Median | Standard Deviation | score on a scale | Week 4 |
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| Secondary | Beck Depression Inventory (BDI) Score | 21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression. | Posted | Median | Standard Deviation | score on a scale | Week 5 |
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| Secondary | Beck Depression Inventory (BDI) Score | 21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression. | Posted | Median | Standard Deviation | score on a scale | Week 8 |
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| Secondary | Beck Depression Inventory (BDI) Score | 21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression. | Posted | Median | Standard Deviation | score on a scale | Week 9 |
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| 0 |
| 13 |
| 0 |
| 13 |
| 7 |
| 13 |
| EG001 | Phytocannabinoid Cannabidiol (CBD) | 600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks). | 0 | 13 | 1 | 13 | 10 | 13 |
| Runny Nose | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sore Throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Muscle Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Appetite Increase | Metabolism and nutrition disorders | Systematic Assessment |
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| Increased Bowl Movement | Gastrointestinal disorders | Systematic Assessment |
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| Body Ache | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Gum Infection | Infections and infestations | Systematic Assessment |
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| Fever | Infections and infestations | Systematic Assessment |
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| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Irregular Heartbeat | Cardiac disorders | Systematic Assessment |
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| Light-Headedness | Nervous system disorders | Systematic Assessment |
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| Drowsy | Nervous system disorders | Systematic Assessment |
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| Suicidal Ideation | Psychiatric disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
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| Gum Problems | Gastrointestinal disorders | Systematic Assessment |
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| Stomach/Abdominal Discomfort | Gastrointestinal disorders | Systematic Assessment |
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| Taste Abnormality | Nervous system disorders | Systematic Assessment |
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| Cognitive Slowing | Psychiatric disorders | Systematic Assessment |
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| Increased Thirst | Metabolism and nutrition disorders | Systematic Assessment |
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| Queasiness | Gastrointestinal disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Euphoria | Psychiatric disorders | Systematic Assessment |
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| Perceptual Problems | Psychiatric disorders | Systematic Assessment |
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| Hair Problems | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Irritability | Psychiatric disorders | Systematic Assessment |
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| Feeling "High" | Psychiatric disorders | Systematic Assessment |
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| Perceptual Enhancement | Psychiatric disorders | Systematic Assessment |
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| Relaxed Breathing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Tiredness/Fatigue | General disorders | Systematic Assessment |
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| Elevated Heptic Enzymes | Hepatobiliary disorders | Systematic Assessment |
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| Vivid Dreaming | Psychiatric disorders | Systematic Assessment |
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| Increased Alcohol Craving | Psychiatric disorders | Systematic Assessment |
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| Concentration Difficulty | Psychiatric disorders | Systematic Assessment |
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| Heartburn / Acid Reflux | Gastrointestinal disorders | Systematic Assessment |
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| Memory Problems | Psychiatric disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Loose Stool | Gastrointestinal disorders | Systematic Assessment |
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| Upper Respiratory Infection | Infections and infestations | Systematic Assessment |
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| Drowsiness | General disorders | Systematic Assessment |
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| Confusion | Psychiatric disorders | Systematic Assessment |
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| Rash / Skin Irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Flu | Infections and infestations | Systematic Assessment |
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| Pink Eye | Eye disorders | Systematic Assessment |
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| Chills | General disorders | Systematic Assessment |
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| Vivid Dreams | Psychiatric disorders | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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Not provided
Not provided
Not provided