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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Tilray | INDUSTRY |
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This project aims to determine whether cannabidiol (CBD), a compound derived from the cannabis plant, is effective in treating alcohol use disorder (AUD) in individuals with comorbid posttraumatic stress disorder (PTSD). Investigators will test the hypothesis that oral cannabidiol (CBD) will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition. Participants (each treated for 6 weeks) will be continuously recruited over a study period of 14 months until 48 have completed. Baseline and weekly data will be collected on alcohol usage and PTSD symptoms, and investigators will assess whether CBD treatment leads to a greater improvement in these measures relative to placebo, and whether reduction in alcohol drinking is temporally linked to improvement in PTSD symptoms. Subjects will also participate in a task designed to quantify the psychological and physiological links between negative emotion produced by re-experiencing PTSD trauma, and alcohol craving. The task will be administered following 4 weeks of treatment. Treatment-associated reduction in alcohol craving elicited by trauma-associated negative emotion between CBD and placebo groups will be compared. This study will be the first to test whether CBD is effective in treating alcohol addiction and in treating PTSD in humans, and the first to examine the interaction between these treatment effects. Results will serve as proof of concept and provide guidance for a future larger clinical trial. Because CBD is a safe, readily available drug, such a trial would have an immense potential to prevent death, medical illness, and psychological suffering associated with AUD and PTSD. Further, because the brain circuits via which CBD acts to produce hypothesized effects are relatively well-understood, results may substantially advance understanding of the neurobiological basis of alcohol addiction.
In this project, investigators aim to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. CBD is currently a medical research focus because it shows promise for treating anxiety and other brain disorders, but does not produce a 'high' like other parts of cannabis, has not been shown to be addictive, and is safe, with few or no side effects. AUD, which is one of the most common and most debilitating psychiatric conditions, is often associated with other comorbid psychiatric disorders - in particular, PTSD: depending on the population studied, 30-60% of individuals with AUD also have PTSD, with high comorbidity rates in military veterans. Evidence from animal models and clinical studies suggests that the negative emotion caused by PTSD symptoms intensifies craving for alcohol during alcohol withdrawal, perpetuating the addictive cycle; further, evidence shows that the brain circuits underlying negative emotion and addiction are linked in a forebrain area called the extended amygdala, which provides a neuropharmacological target to simultaneously treat both negative emotion and alcohol addiction in individuals with AUD and PTSD. CBD is known to inhibit brain activity in the extended amygdala, leading to reduced anxiety in both animal models and humans. CBD also reduces addictive alcohol seeking in animal models.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabidiol (CBD 600 mg daily) | Experimental | 6 weeks, such that both participants and study staff are blind to treatment condition. |
|
| Placebo | Placebo Comparator | 6 weeks, such that both participants and study staff are blind to treatment condition. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol | Drug | 600 mg daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Drinks Per Day | Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking. | Baseline |
| Number of Drinks Per Day | Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking. | Week 4 |
| Number of Drinks Per Day | Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking. | Week 6 |
| PCL-5 Total Score | The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms. | Baseline |
| PCL-5 Total Score | The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Carbohydrate Deficient Transferrin (CDT) | CDT test performed on blood sample | Baseline |
| Percent Carbohydrate Deficient Transferrin (CDT) | CDT test performed on blood sample |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Marmar, MD | 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39719161 | Derived | Raymond JS, Athanasopoulos AG, Badolato CJ, Doolan TJ, Scicluna RL, Everett NA, Bowen MT, James MH. Emerging medications and pharmacological treatment approaches for substance use disorders. Pharmacol Biochem Behav. 2025 Mar;248:173952. doi: 10.1016/j.pbb.2024.173952. Epub 2024 Dec 22. |
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A total of 95 patients were enrolled in the trial. 65 of those failed screening or were lost to follow-up prior to starting medication. Thus, only 30 participants started medication in the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cannabidiol (CBD 600 mg Daily) | 6 weeks, such that both participants and study staff are blind to treatment condition. Cannabidiol: 600 mg daily |
| FG001 | Placebo | 6 weeks, such that both participants and study staff are blind to treatment condition. Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cannabidiol (CBD 600 mg Daily) | 6 weeks, such that both participants and study staff are blind to treatment condition. Cannabidiol: 600 mg daily |
| BG001 | Placebo | 6 weeks, such that both participants and study staff are blind to treatment condition. Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition. |
| 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 | Number of Drinks Per Day | Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking. | Posted | Mean | Standard Deviation | drinks/day | Baseline |
|
9 weeks
Collection approach was systematic, a study Nurse Practitioner of Physician collected the SAFTEE form Part A (with Parts B and C as needed) to collect AEs from a list of known drug effects. This assessment includes questions related to description of AE, timeline, severity, relatedness to study drug/participation, etc. This assessment was completed on a weekly basis from the baseline assessment to week 7 and then again at the week 9 followup. All AEs were reviewed with the PI.
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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 | Cannabidiol (CBD 600 mg Daily) | 6 weeks, such that both participants and study staff are blind to treatment condition. Cannabidiol: 600 mg daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles Marmar, MD | NYU Langone Health | 646-754-4855 | Charles.marmar@nyumc.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 | Jan 5, 2022 | Apr 21, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 8, 2022 | May 12, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Placebos | Drug | This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be administered to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition. |
|
| Week 4 |
| PCL-5 Total Score | The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms. | Week 6 |
| Week 4 |
| Percent Carbohydrate Deficient Transferrin (CDT) | CDT test performed on blood sample | Week 6 |
| Percentage of Heavy Drinking Days | Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week. | Baseline |
| Percentage of Heavy Drinking Days | Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week. | Week 1 |
| Percentage of Heavy Drinking Days | Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week. | Week 2 |
| Percentage of Heavy Drinking Days | Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week. | Week 3 |
| Percentage of Heavy Drinking Days | Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week. | Week 4 |
| Percentage of Heavy Drinking Days | Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week. | Week 5 |
| Percentage of Heavy Drinking Days | Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week. | Week 6 |
| Percentage of Very Heavy Drinking Days | Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week. | Baseline |
| Percentage of Very Heavy Drinking Days | Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week. | Week 1 |
| Percentage of Very Heavy Drinking Days | Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week. | Week 2 |
| Percentage of Very Heavy Drinking Days | Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week. | Week 3 |
| Percentage of Very Heavy Drinking Days | Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week. | Week 4 |
| Percentage of Very Heavy Drinking Days | Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week. | Week 5 |
| Percentage of Very Heavy Drinking Days | Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week. | Week 6 |
| Number of Participants With No Heavy Drinking Days | Baseline |
| Number of Participants With No Heavy Drinking Days | Week 1 |
| Number of Participants With No Heavy Drinking Days | Week 2 |
| Number of Participants With No Heavy Drinking Days | Week 3 |
| Number of Participants With No Heavy Drinking Days | Week 4 |
| Number of Participants With No Heavy Drinking Days | Week 5 |
| Number of Participants With No Heavy Drinking Days | Week 6 |
| Number of Participants That Are 'Present and Clear' | Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero. | Baseline |
| Number of Participants That Are 'Present and Clear' | Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero. | Week 1 |
| Number of Participants That Are 'Present and Clear' | Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero. | Week 2 |
| Number of Participants That Are 'Present and Clear' | Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero. | Week 3 |
| Number of Participants That Are 'Present and Clear' | Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero. | Week 4 |
| Number of Participants That Are 'Present and Clear' | Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero. | Week 5 |
| Number of Participants That Are 'Present and Clear' | Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero. | Week 6 |
| Percentage of Days Abstinent | Baseline |
| Percentage of Days Abstinent | Week 1 |
| Percentage of Days Abstinent | Week 2 |
| Percentage of Days Abstinent | Week 3 |
| Percentage of Days Abstinent | Week 4 |
| Percentage of Days Abstinent | Week 5 |
| Percentage of Days Abstinent | Week 6 |
| Institution Mandated COVID-19 Research Pause |
|
| Lost to Follow-up |
|
| 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 |
|
|
|
| Primary | Number of Drinks Per Day | Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking. | Posted | Mean | Standard Deviation | drinks/day | Week 4 |
|
|
|
| Primary | Number of Drinks Per Day | Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking. | Posted | Mean | Standard Deviation | drinks/day | Week 6 |
|
|
|
| Primary | PCL-5 Total Score | The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Primary | PCL-5 Total Score | The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms. | Posted | Mean | Standard Deviation | score on a scale | Week 4 |
|
|
|
| Primary | PCL-5 Total Score | The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms. | Posted | Mean | Standard Deviation | score on a scale | Week 6 |
|
|
|
| Secondary | Percent Carbohydrate Deficient Transferrin (CDT) | CDT test performed on blood sample | Posted | Mean | Full Range | percentage of CDT | Baseline |
|
|
|
| Secondary | Percent Carbohydrate Deficient Transferrin (CDT) | CDT test performed on blood sample | Posted | Mean | Full Range | percentage of CDT | Week 4 |
|
|
|
| Secondary | Percent Carbohydrate Deficient Transferrin (CDT) | CDT test performed on blood sample | Posted | Mean | Full Range | percentage of CDT | Week 6 |
|
|
|
| Secondary | Percentage of Heavy Drinking Days | Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week. | Posted | Mean | Full Range | percentage of days | Baseline |
|
|
|
| Secondary | Percentage of Heavy Drinking Days | Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week. | Posted | Mean | Full Range | percentage of days | Week 1 |
|
|
|
| Secondary | Percentage of Heavy Drinking Days | Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week. | Posted | Mean | Full Range | percentage of days | Week 2 |
|
|
|
| Secondary | Percentage of Heavy Drinking Days | Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week. | Posted | Mean | Full Range | percentage of days | Week 3 |
|
|
|
| Secondary | Percentage of Heavy Drinking Days | Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week. | Posted | Mean | Full Range | percentage of days | Week 4 |
|
|
|
| Secondary | Percentage of Heavy Drinking Days | Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week. | Posted | Mean | Full Range | percentage of days | Week 5 |
|
|
|
| Secondary | Percentage of Heavy Drinking Days | Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week. | Posted | Mean | Full Range | percentage of days | Week 6 |
|
|
|
| Secondary | Percentage of Very Heavy Drinking Days | Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week. | Posted | Mean | Full Range | percentage of days | Baseline |
|
|
|
| Secondary | Percentage of Very Heavy Drinking Days | Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week. | Posted | Mean | Full Range | percentage of days | Week 1 |
|
|
|
| Secondary | Percentage of Very Heavy Drinking Days | Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week. | Posted | Mean | Full Range | percentage of days | Week 2 |
|
|
|
| Secondary | Percentage of Very Heavy Drinking Days | Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week. | Posted | Mean | Full Range | percentage of days | Week 3 |
|
|
|
| Secondary | Percentage of Very Heavy Drinking Days | Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week. | Posted | Mean | Full Range | percentage of days | Week 4 |
|
|
|
| Secondary | Percentage of Very Heavy Drinking Days | Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week. | Posted | Mean | Full Range | percentage of days | Week 5 |
|
|
|
| Secondary | Percentage of Very Heavy Drinking Days | Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week. | Posted | Mean | Full Range | percentage of days | Week 6 |
|
|
|
| Secondary | Number of Participants With No Heavy Drinking Days | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Number of Participants With No Heavy Drinking Days | Posted | Count of Participants | Participants | Week 1 |
|
|
|
| Secondary | Number of Participants With No Heavy Drinking Days | Posted | Count of Participants | Participants | Week 2 |
|
|
|
| Secondary | Number of Participants With No Heavy Drinking Days | Posted | Count of Participants | Participants | Week 3 |
|
|
|
| Secondary | Number of Participants With No Heavy Drinking Days | Posted | Count of Participants | Participants | Week 4 |
|
|
|
| Secondary | Number of Participants With No Heavy Drinking Days | Posted | Count of Participants | Participants | Week 5 |
|
|
|
| Secondary | Number of Participants With No Heavy Drinking Days | Posted | Count of Participants | Participants | Week 6 |
|
|
|
| Secondary | Number of Participants That Are 'Present and Clear' | Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Number of Participants That Are 'Present and Clear' | Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero. | Posted | Count of Participants | Participants | Week 1 |
|
|
|
| Secondary | Number of Participants That Are 'Present and Clear' | Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero. | Posted | Count of Participants | Participants | Week 2 |
|
|
|
| Secondary | Number of Participants That Are 'Present and Clear' | Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero. | Posted | Count of Participants | Participants | Week 3 |
|
|
|
| Secondary | Number of Participants That Are 'Present and Clear' | Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero. | Posted | Count of Participants | Participants | Week 4 |
|
|
|
| Secondary | Number of Participants That Are 'Present and Clear' | Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero. | Posted | Count of Participants | Participants | Week 5 |
|
|
|
| Secondary | Number of Participants That Are 'Present and Clear' | Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero. | Posted | Count of Participants | Participants | Week 6 |
|
|
|
| Secondary | Percentage of Days Abstinent | Posted | Mean | Full Range | percentage of days | Baseline |
|
|
|
| Secondary | Percentage of Days Abstinent | Posted | Mean | Full Range | percentage of days | Week 1 |
|
|
|
| Secondary | Percentage of Days Abstinent | Posted | Mean | Full Range | percentage of days | Week 2 |
|
|
|
| Secondary | Percentage of Days Abstinent | Posted | Mean | Full Range | percentage of days | Week 3 |
|
|
|
| Secondary | Percentage of Days Abstinent | Posted | Mean | Full Range | percentage of days | Week 4 |
|
|
|
| Secondary | Percentage of Days Abstinent | Posted | Mean | Full Range | percentage of days | Week 5 |
|
|
|
| Secondary | Percentage of Days Abstinent | Posted | Mean | Full Range | percentage of days | Week 6 |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 15 |
| 17 |
| EG001 | Placebo | 6 weeks, such that both participants and study staff are blind to treatment condition. Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition. | 0 | 13 | 0 | 13 | 10 | 13 |
| Lightheadedness/Dizziness | General disorders | Systematic Assessment |
|
| Thyroid Nodule | Endocrine disorders | Systematic Assessment |
|
| Acid Reflux | Gastrointestinal disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Blurry Vision | Eye disorders | Systematic Assessment |
|
| Cold/Flu Symptoms | General disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Drowsiness | General disorders | Systematic Assessment |
|
| Elevated liver enzymes | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Feeling Overwhelmed | Psychiatric disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Headache | Gastrointestinal disorders | Systematic Assessment |
|
| Hypotension | Cardiac disorders | Systematic Assessment |
|
| Increased Hunger | General disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
| Irregular heartbeat | Cardiac disorders | Systematic Assessment |
|
| Lack of motivation | Psychiatric disorders | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Nightmares | General disorders | Systematic Assessment |
|
| Perceptual problems | General disorders | Systematic Assessment |
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| Arm surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Feeling hot | General disorders | Systematic Assessment |
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| Weight gain | General disorders | Systematic Assessment |
|
| Shortness of breath | Vascular disorders | Systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Suicidal ideation (wish to be dead) | Psychiatric disorders | Systematic Assessment |
|
| Sweating | General disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |