Trial Outcomes & Findings for Cannabidiol as a Treatment for AUD Comorbid With PTSD (NCT NCT03248167)
NCT ID: NCT03248167
Last Updated: 2023-06-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
95 participants
Primary outcome timeframe
Baseline
Results posted on
2023-06-28
Participant Flow
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.
Participant milestones
| Measure |
Cannabidiol (CBD 600 mg Daily)
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
13
|
|
Overall Study
COMPLETED
|
12
|
9
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Cannabidiol (CBD 600 mg Daily)
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Institution Mandated COVID-19 Research Pause
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Cannabidiol as a Treatment for AUD Comorbid With PTSD
Baseline characteristics by cohort
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=17 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=13 Participants
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.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.59 years
n=5 Participants
|
37.69 years
n=7 Participants
|
38.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
13 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineNumber 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.
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=17 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=13 Participants
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 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.
|
|---|---|---|
|
Number of Drinks Per Day
|
4.4885 drinks/day
Standard Deviation 2.6620
|
5.3623 drinks/day
Standard Deviation 2.7075
|
PRIMARY outcome
Timeframe: Week 4Number 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.
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=12 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=10 Participants
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 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.
|
|---|---|---|
|
Number of Drinks Per Day
|
1.9256 drinks/day
Standard Deviation 2.1786
|
2.15 drinks/day
Standard Deviation 2.2792
|
PRIMARY outcome
Timeframe: Week 6Number 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.
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=12 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=9 Participants
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 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.
|
|---|---|---|
|
Number of Drinks Per Day
|
2.4881 drinks/day
Standard Deviation 2.1679
|
2.8175 drinks/day
Standard Deviation 2.2682
|
PRIMARY outcome
Timeframe: BaselineThe 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.
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=17 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=13 Participants
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 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.
|
|---|---|---|
|
PCL-5 Total Score
|
42.0588 score on a scale
Standard Deviation 13.8549
|
49.1538 score on a scale
Standard Deviation 13.7739
|
PRIMARY outcome
Timeframe: Week 4The 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.
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=13 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=10 Participants
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 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.
|
|---|---|---|
|
PCL-5 Total Score
|
19.9231 score on a scale
Standard Deviation 15.7116
|
29.9 score on a scale
Standard Deviation 16.7559
|
PRIMARY outcome
Timeframe: Week 6The 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.
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=11 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=9 Participants
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 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.
|
|---|---|---|
|
PCL-5 Total Score
|
26.6364 score on a scale
Standard Deviation 18.4921
|
26.8889 score on a scale
Standard Deviation 17.7331
|
SECONDARY outcome
Timeframe: BaselineCDT test performed on blood sample
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=17 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=13 Participants
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 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.
|
|---|---|---|
|
Percent Carbohydrate Deficient Transferrin (CDT)
|
1.1118 percentage of CDT
Interval 0.6 to 2.6
|
2.2833 percentage of CDT
Interval 0.5 to 8.8
|
SECONDARY outcome
Timeframe: Week 4CDT test performed on blood sample
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=11 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=9 Participants
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 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.
|
|---|---|---|
|
Percent Carbohydrate Deficient Transferrin (CDT)
|
1.0909 percentage of CDT
Interval 0.6 to 2.1
|
1.4222 percentage of CDT
Interval 0.6 to 3.4
|
SECONDARY outcome
Timeframe: Week 6CDT test performed on blood sample
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=10 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=8 Participants
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 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.
|
|---|---|---|
|
Percent Carbohydrate Deficient Transferrin (CDT)
|
1.14 percentage of CDT
Interval 0.7 to 1.9
|
1.6625 percentage of CDT
Interval 0.6 to 5.8
|
SECONDARY outcome
Timeframe: BaselineHeavy 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.
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=17 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=13 Participants
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 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.
|
|---|---|---|
|
Percentage of Heavy Drinking Days
|
49 percentage of days
Interval 17.0 to 97.0
|
58 percentage of days
Interval 13.0 to 100.0
|
SECONDARY outcome
Timeframe: Week 1Heavy 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.
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=16 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=13 Participants
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 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.
|
|---|---|---|
|
Percentage of Heavy Drinking Days
|
29 percentage of days
Interval 0.0 to 100.0
|
31 percentage of days
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: Week 2Heavy 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.
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=16 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=12 Participants
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 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.
|
|---|---|---|
|
Percentage of Heavy Drinking Days
|
25 percentage of days
Interval 0.0 to 100.0
|
31 percentage of days
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: Week 3Heavy 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.
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=14 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=11 Participants
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 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.
|
|---|---|---|
|
Percentage of Heavy Drinking Days
|
21 percentage of days
Interval 0.0 to 100.0
|
21 percentage of days
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: Week 4Heavy 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.
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=12 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=9 Participants
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 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.
|
|---|---|---|
|
Percentage of Heavy Drinking Days
|
23 percentage of days
Interval 0.0 to 100.0
|
25 percentage of days
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: Week 5Heavy 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.
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=12 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=9 Participants
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 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.
|
|---|---|---|
|
Percentage of Heavy Drinking Days
|
26 percentage of days
Interval 0.0 to 100.0
|
32 percentage of days
Interval 0.0 to 86.0
|
SECONDARY outcome
Timeframe: Week 6Heavy 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.
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=12 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=9 Participants
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 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.
|
|---|---|---|
|
Percentage of Heavy Drinking Days
|
21 percentage of days
Interval 0.0 to 100.0
|
39 percentage of days
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: BaselineVery heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=17 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=13 Participants
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 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.
|
|---|---|---|
|
Percentage of Very Heavy Drinking Days
|
17 percentage of days
Interval 0.0 to 67.0
|
27 percentage of days
Interval 0.0 to 77.0
|
SECONDARY outcome
Timeframe: Week 1Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=17 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=13 Participants
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 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.
|
|---|---|---|
|
Percentage of Very Heavy Drinking Days
|
4 percentage of days
Interval 0.0 to 25.0
|
4 percentage of days
Interval 0.0 to 25.0
|
SECONDARY outcome
Timeframe: Week 2Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=16 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=12 Participants
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 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.
|
|---|---|---|
|
Percentage of Very Heavy Drinking Days
|
4 percentage of days
Interval 0.0 to 29.0
|
4 percentage of days
Interval 0.0 to 33.0
|
SECONDARY outcome
Timeframe: Week 3Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=14 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=11 Participants
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 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.
|
|---|---|---|
|
Percentage of Very Heavy Drinking Days
|
5 percentage of days
Interval 0.0 to 43.0
|
1 percentage of days
Interval 0.0 to 14.0
|
SECONDARY outcome
Timeframe: Week 4Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=12 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=10 Participants
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 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.
|
|---|---|---|
|
Percentage of Very Heavy Drinking Days
|
1 percentage of days
Interval 0.0 to 14.0
|
1 percentage of days
Interval 0.0 to 14.0
|
SECONDARY outcome
Timeframe: Week 5Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=12 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=9 Participants
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 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.
|
|---|---|---|
|
Percentage of Very Heavy Drinking Days
|
2 percentage of days
Interval 0.0 to 14.0
|
3 percentage of days
Interval 0.0 to 29.0
|
SECONDARY outcome
Timeframe: Week 6Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=12 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=9 Participants
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 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.
|
|---|---|---|
|
Percentage of Very Heavy Drinking Days
|
2 percentage of days
Interval 0.0 to 14.0
|
5 percentage of days
Interval 0.0 to 29.0
|
SECONDARY outcome
Timeframe: BaselineOutcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=17 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=13 Participants
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 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.
|
|---|---|---|
|
Number of Participants With No Heavy Drinking Days
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 1Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=17 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=13 Participants
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 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.
|
|---|---|---|
|
Number of Participants With No Heavy Drinking Days
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Week 2Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=16 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=12 Participants
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 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.
|
|---|---|---|
|
Number of Participants With No Heavy Drinking Days
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Week 3Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=14 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=11 Participants
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 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.
|
|---|---|---|
|
Number of Participants With No Heavy Drinking Days
|
9 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Week 4Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=12 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=10 Participants
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 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.
|
|---|---|---|
|
Number of Participants With No Heavy Drinking Days
|
7 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Week 5Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=12 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=9 Participants
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 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.
|
|---|---|---|
|
Number of Participants With No Heavy Drinking Days
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Week 6Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=12 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=9 Participants
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 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.
|
|---|---|---|
|
Number of Participants With No Heavy Drinking Days
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: BaselinePresent is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=17 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=13 Participants
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 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.
|
|---|---|---|
|
Number of Participants That Are 'Present and Clear'
|
17 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Week 1Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=16 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=13 Participants
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 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.
|
|---|---|---|
|
Number of Participants That Are 'Present and Clear'
|
16 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Week 2Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=16 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=13 Participants
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 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.
|
|---|---|---|
|
Number of Participants That Are 'Present and Clear'
|
16 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Week 3Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=14 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=11 Participants
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 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.
|
|---|---|---|
|
Number of Participants That Are 'Present and Clear'
|
14 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Week 4Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=12 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=10 Participants
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 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.
|
|---|---|---|
|
Number of Participants That Are 'Present and Clear'
|
12 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Week 5Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=12 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=9 Participants
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 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.
|
|---|---|---|
|
Number of Participants That Are 'Present and Clear'
|
12 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Week 6Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.
Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=12 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=9 Participants
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 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.
|
|---|---|---|
|
Number of Participants That Are 'Present and Clear'
|
12 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: BaselineOutcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=17 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=13 Participants
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 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.
|
|---|---|---|
|
Percentage of Days Abstinent
|
30 percentage of days
Interval 0.0 to 77.0
|
34 percentage of days
Interval 0.0 to 87.0
|
SECONDARY outcome
Timeframe: Week 1Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=16 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=13 Participants
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 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.
|
|---|---|---|
|
Percentage of Days Abstinent
|
55 percentage of days
Interval 0.0 to 100.0
|
57 percentage of days
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: Week 2Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=16 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=13 Participants
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 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.
|
|---|---|---|
|
Percentage of Days Abstinent
|
55 percentage of days
Interval 0.0 to 100.0
|
53 percentage of days
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: Week 3Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=14 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=11 Participants
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 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.
|
|---|---|---|
|
Percentage of Days Abstinent
|
66 percentage of days
Interval 0.0 to 100.0
|
56 percentage of days
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: Week 4Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=12 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=10 Participants
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 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.
|
|---|---|---|
|
Percentage of Days Abstinent
|
56 percentage of days
Interval 0.0 to 100.0
|
57 percentage of days
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: Week 5Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=12 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=9 Participants
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 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.
|
|---|---|---|
|
Percentage of Days Abstinent
|
52 percentage of days
Interval 0.0 to 100.0
|
51 percentage of days
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: Week 6Outcome measures
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=12 Participants
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=9 Participants
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 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.
|
|---|---|---|
|
Percentage of Days Abstinent
|
48 percentage of days
Interval 0.0 to 100.0
|
46 percentage of days
Interval 0.0 to 100.0
|
Adverse Events
Cannabidiol (CBD 600 mg Daily)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cannabidiol (CBD 600 mg Daily)
n=17 participants at risk
6 weeks, such that both participants and study staff are blind to treatment condition.
Cannabidiol: 600 mg daily
|
Placebo
n=13 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Anxiety
|
0.00%
0/17 • 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.
|
7.7%
1/13 • 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.
|
|
General disorders
Lightheadedness/Dizziness
|
5.9%
1/17 • 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.
|
7.7%
1/13 • 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.
|
|
Endocrine disorders
Thyroid Nodule
|
5.9%
1/17 • 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.
|
0.00%
0/13 • 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.
|
|
Gastrointestinal disorders
Acid Reflux
|
5.9%
1/17 • 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.
|
0.00%
0/13 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
1/17 • 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.
|
0.00%
0/13 • 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.
|
|
Eye disorders
Blurry Vision
|
5.9%
1/17 • 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.
|
7.7%
1/13 • 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.
|
|
General disorders
Cold/Flu Symptoms
|
5.9%
1/17 • 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.
|
7.7%
1/13 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
1/17 • 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.
|
0.00%
0/13 • 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.
|
|
Gastrointestinal disorders
Diarrhea
|
17.6%
3/17 • 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.
|
7.7%
1/13 • 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.
|
|
General disorders
Drowsiness
|
35.3%
6/17 • 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.
|
30.8%
4/13 • 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.
|
|
General disorders
Elevated liver enzymes
|
5.9%
1/17 • 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.
|
0.00%
0/13 • 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.
|
|
General disorders
Fatigue
|
11.8%
2/17 • 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.
|
7.7%
1/13 • 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.
|
|
Psychiatric disorders
Feeling Overwhelmed
|
5.9%
1/17 • 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.
|
0.00%
0/13 • 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.
|
|
General disorders
Fever
|
5.9%
1/17 • 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.
|
0.00%
0/13 • 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.
|
|
Gastrointestinal disorders
Headache
|
11.8%
2/17 • 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.
|
0.00%
0/13 • 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.
|
|
Cardiac disorders
Hypotension
|
5.9%
1/17 • 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.
|
0.00%
0/13 • 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.
|
|
General disorders
Increased Hunger
|
11.8%
2/17 • 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.
|
7.7%
1/13 • 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.
|
|
General disorders
Insomnia
|
5.9%
1/17 • 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.
|
7.7%
1/13 • 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.
|
|
Cardiac disorders
Irregular heartbeat
|
0.00%
0/17 • 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.
|
7.7%
1/13 • 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.
|
|
Psychiatric disorders
Lack of motivation
|
5.9%
1/17 • 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.
|
0.00%
0/13 • 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.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/17 • 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.
|
7.7%
1/13 • 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.
|
|
Gastrointestinal disorders
Nausea
|
17.6%
3/17 • 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.
|
0.00%
0/13 • 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.
|
|
General disorders
Nightmares
|
5.9%
1/17 • 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.
|
15.4%
2/13 • 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.
|
|
General disorders
Perceptual problems
|
5.9%
1/17 • 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.
|
0.00%
0/13 • 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.
|
|
Musculoskeletal and connective tissue disorders
Arm surgery
|
5.9%
1/17 • 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.
|
0.00%
0/13 • 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.
|
|
General disorders
Feeling hot
|
5.9%
1/17 • 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.
|
0.00%
0/13 • 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.
|
|
General disorders
Weight gain
|
17.6%
3/17 • 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.
|
15.4%
2/13 • 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.
|
|
Vascular disorders
Shortness of breath
|
5.9%
1/17 • 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.
|
0.00%
0/13 • 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.
|
|
Gastrointestinal disorders
Stomach discomfort
|
5.9%
1/17 • 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.
|
7.7%
1/13 • 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.
|
|
Psychiatric disorders
Suicidal ideation (wish to be dead)
|
5.9%
1/17 • 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.
|
0.00%
0/13 • 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.
|
|
General disorders
Sweating
|
0.00%
0/17 • 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.
|
7.7%
1/13 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place