Trial Outcomes & Findings for Effects of Cannabidiol in Alcohol Use Disorder (NCT NCT03252756)
NCT ID: NCT03252756
Last Updated: 2023-05-03
Results Overview
CBD "trough" plasma levels measured before dosing with CBD.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Baseline
Results posted on
2023-05-03
Participant Flow
Participant milestones
| Measure |
600mg Saline/Day for 4 Weeks, Then 1200mg Saline/Day for 4 Weeks
600mg Saline/ day (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
600mg CBD/Day for 4 Weeks, Then 1200mg CBD/Day for 4 Weeks
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
600mg Saline/Day for 4 Weeks, Then 1200mg Saline/Day for 4 Weeks
600mg Saline/ day (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
600mg CBD/Day for 4 Weeks, Then 1200mg CBD/Day for 4 Weeks
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
4
|
|
Overall Study
COVID-19 Pandemic
|
1
|
1
|
|
Overall Study
Study Drug Expiration
|
0
|
1
|
Baseline Characteristics
Effects of Cannabidiol in Alcohol Use Disorder
Baseline characteristics by cohort
| Measure |
600mg Saline/Day for 4 Weeks, Then 1200mg Saline/Day for 4 Weeks
n=10 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
600mg CBD/Day for 4 Weeks, Then 1200mg CBD/Day for 4 Weeks
n=8 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.1 years
STANDARD_DEVIATION 9.71 • n=5 Participants
|
37.75 years
STANDARD_DEVIATION 12.89 • n=7 Participants
|
41.83 years
STANDARD_DEVIATION 11.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
8 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineCBD "trough" plasma levels measured before dosing with CBD.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=12 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=12 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Trough CBD Plasma Levels
|
0.7 CBD (ng/mL)
Standard Deviation 2.41
|
0 CBD (ng/mL)
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Week 1CBD "trough" plasma levels measured before dosing with CBD.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=12 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=11 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Trough CBD Plasma Levels
|
22.79 CBD (ng/mL)
Standard Deviation 16.44
|
0 CBD (ng/mL)
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Week 4CBD "trough" plasma levels measured before dosing with CBD.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=9 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=8 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Trough CBD Plasma Levels
|
31.21 CBD (ng/mL)
Standard Deviation 20.91
|
0.94 CBD (ng/mL)
Standard Deviation 2.66
|
PRIMARY outcome
Timeframe: Week 5CBD "trough" plasma levels measured before dosing with CBD.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=8 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=9 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Trough CBD Plasma Levels
|
74.54 CBD (ng/mL)
Standard Deviation 44.85
|
0 CBD (ng/mL)
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Week 8CBD "trough" plasma levels measured before dosing with CBD.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=6 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=8 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Trough CBD Plasma Levels
|
100.03 CBD (ng/mL)
Standard Deviation 45.13
|
0 CBD (ng/mL)
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Week 9CBD "trough" plasma levels measured before dosing with CBD.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=6 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=9 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Trough CBD Plasma Levels
|
22.71 CBD (ng/mL)
Standard Deviation 19.67
|
0 CBD (ng/mL)
Standard Deviation 0
|
PRIMARY outcome
Timeframe: BaselineCBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=12 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=12 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Peak CBD Plasma Levels
|
52.04 CBD (ng/mL)
Standard Deviation 68.78
|
0 CBD (ng/mL)
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Day 1CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=11 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=11 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Peak CBD Plasma Levels
|
104.45 CBD (ng/mL)
Standard Deviation 99.24
|
0.67 CBD (ng/mL)
Standard Deviation 2.22
|
PRIMARY outcome
Timeframe: Week 1CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=12 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=10 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Peak CBD Plasma Levels
|
83.67 CBD (ng/mL)
Standard Deviation 67.34
|
0 CBD (ng/mL)
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Week 4CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=9 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=8 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Peak CBD Plasma Levels
|
211.83 CBD (ng/mL)
Standard Deviation 197.34
|
0.94 CBD (ng/mL)
Standard Deviation 2.65
|
PRIMARY outcome
Timeframe: Week 4 + 1 DayCBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=8 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=9 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Peak CBD Plasma Levels
|
102.74 CBD (ng/mL)
Standard Deviation 117.59
|
66.17 CBD (ng/mL)
Standard Deviation 198.52
|
PRIMARY outcome
Timeframe: Week 5CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=8 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=9 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Peak CBD Plasma Levels
|
178.91 CBD (ng/mL)
Standard Deviation 211.35
|
0 CBD (ng/mL)
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Week 8CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=6 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=7 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Peak CBD Plasma Levels
|
275.012 CBD (ng/mL)
Standard Deviation 236.42
|
0 CBD (ng/mL)
Standard Deviation 0
|
SECONDARY outcome
Timeframe: BaselineThe percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=13 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=12 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Percentage of Heavy Drinking Days
|
46.67 percentage of days
Standard Deviation 28.32
|
58.6 percentage of days
Standard Deviation 30.10
|
SECONDARY outcome
Timeframe: Week 1The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=13 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=12 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Percent of Heavy Drinking Days
|
32.97 percentage of days
Standard Deviation 32.15
|
35.71 percentage of days
Standard Deviation 34.73
|
SECONDARY outcome
Timeframe: Week 2The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=11 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=10 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Percent of Heavy Drinking Days
|
17.86 percentage of days
Standard Deviation 22.38
|
37.14 percentage of days
Standard Deviation 37.45
|
SECONDARY outcome
Timeframe: Week 3The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=11 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=10 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Percent of Heavy Drinking Days
|
16.88 percentage of days
Standard Deviation 24.59
|
32.86 percentage of days
Standard Deviation 37.53
|
SECONDARY outcome
Timeframe: Week 4The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=10 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=10 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Percent of Heavy Drinking Days
|
21.43 percentage of days
Standard Deviation 23.57
|
41.43 percentage of days
Standard Deviation 35.28
|
SECONDARY outcome
Timeframe: Week 5The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=9 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=10 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Percent of Heavy Drinking Days
|
20.63 percentage of days
Standard Deviation 28.67
|
15.71 percentage of days
Standard Deviation 24.70
|
SECONDARY outcome
Timeframe: Week 6The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=9 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=10 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Percent of Heavy Drinking Days
|
20.63 percentage of days
Standard Deviation 21.56
|
18.57 percentage of days
Standard Deviation 31.62
|
SECONDARY outcome
Timeframe: Week 7The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=9 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=10 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Percent of Heavy Drinking Days
|
23.81 percentage of days
Standard Deviation 20.20
|
18.57 percentage of days
Standard Deviation 31.62
|
SECONDARY outcome
Timeframe: Week 8The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=9 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=10 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Percent of Heavy Drinking Days
|
12.70 percentage of days
Standard Deviation 15.06
|
18.57 percentage of days
Standard Deviation 22.39
|
SECONDARY outcome
Timeframe: Week 9The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=9 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=10 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Percent of Heavy Drinking Days
|
15.87 percentage of days
Standard Deviation 15.06
|
24.29 percentage of days
Standard Deviation 36.92
|
SECONDARY outcome
Timeframe: BaselineThe number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=13 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=12 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Number of Drinks Per Day
|
4.61 Drinks per day
Standard Deviation 2.17
|
5.38 Drinks per day
Standard Deviation 2.40
|
SECONDARY outcome
Timeframe: Week 1The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=13 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=12 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Number of Drinks Per Day
|
2.91 drinks per day
Standard Deviation 2.28
|
3.23 drinks per day
Standard Deviation 2.55
|
SECONDARY outcome
Timeframe: Week 2The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=11 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=10 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Number of Drinks Per Day
|
2.37 drinks per day
Standard Deviation 2.03
|
4.36 drinks per day
Standard Deviation 5.30
|
SECONDARY outcome
Timeframe: Week 3The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=11 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=10 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Number of Drinks Per Day
|
1.83 drinks per day
Standard Deviation 1.77
|
3.28 drinks per day
Standard Deviation 3.17
|
SECONDARY outcome
Timeframe: Week 4The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=10 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=10 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Number of Drinks Per Day
|
2.13 drinks per day
Standard Deviation 2.00
|
4.49 drinks per day
Standard Deviation 3.36
|
SECONDARY outcome
Timeframe: Week 5The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=9 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=10 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Number of Drinks Per Day
|
2.39 drinks per day
Standard Deviation 2.14
|
1.66 drinks per day
Standard Deviation 1.92
|
SECONDARY outcome
Timeframe: Week 6The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=9 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=10 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Number of Drinks Per Day
|
2.38 drinks per day
Standard Deviation 1.94
|
1.82 drinks per day
Standard Deviation 2.39
|
SECONDARY outcome
Timeframe: Week 7The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=9 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=10 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Number of Drinks Per Day
|
2.57 drinks per day
Standard Deviation 1.95
|
1.82 drinks per day
Standard Deviation 2.39
|
SECONDARY outcome
Timeframe: Week 8The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=9 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=10 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Number of Drinks Per Day
|
1.99 drinks per day
Standard Deviation 1.60
|
2.26 drinks per day
Standard Deviation 2.73
|
SECONDARY outcome
Timeframe: Week 9The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=9 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=10 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Number of Drinks Per Day
|
2.40 drinks per day
Standard Deviation 2.32
|
3.17 drinks per day
Standard Deviation 4.28
|
SECONDARY outcome
Timeframe: Baseline5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=13 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=11 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Penn Alcohol Craving Scale (PACS) Score
|
17.77 score on a scale
Standard Deviation 5.46
|
14.20 score on a scale
Standard Deviation 4.58
|
SECONDARY outcome
Timeframe: Week 15-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=11 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=11 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Penn Alcohol Craving Scale (PACS) Score
|
14.09 score on a scale
Standard Deviation 7.69
|
13.45 score on a scale
Standard Deviation 7.16
|
SECONDARY outcome
Timeframe: Week 45-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=9 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=9 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Penn Alcohol Craving Scale (PACS) Score
|
10.33 score on a scale
Standard Deviation 4.56
|
13.67 score on a scale
Standard Deviation 6.98
|
SECONDARY outcome
Timeframe: Week 55-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=9 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=9 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Penn Alcohol Craving Scale (PACS) Score
|
11.78 score on a scale
Standard Deviation 6.08
|
11.78 score on a scale
Standard Deviation 6.51
|
SECONDARY outcome
Timeframe: Week 85-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=9 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=9 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Penn Alcohol Craving Scale (PACS) Score
|
11.56 score on a scale
Standard Deviation 5.10
|
10.22 score on a scale
Standard Deviation 5.87
|
SECONDARY outcome
Timeframe: Week 95-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=6 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=9 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Penn Alcohol Craving Scale (PACS) Score
|
11.33 score on a scale
Standard Deviation 3.72
|
8.22 score on a scale
Standard Deviation 5.40
|
SECONDARY outcome
Timeframe: Baseline21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=13 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=12 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Beck Anxiety Inventory (BAI) Score
|
8 score on a scale
Standard Deviation 7.40
|
6.92 score on a scale
Standard Deviation 5.12
|
SECONDARY outcome
Timeframe: Week 121-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=12 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=10 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Beck Anxiety Inventory (BAI) Score
|
8 score on a scale
Standard Deviation 8.81
|
5.6 score on a scale
Standard Deviation 7.14
|
SECONDARY outcome
Timeframe: Week 421-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=9 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=9 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Beck Anxiety Inventory (BAI) Score
|
11.33 score on a scale
Standard Deviation 8.59
|
3.33 score on a scale
Standard Deviation 4.39
|
SECONDARY outcome
Timeframe: Week 521-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=7 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=10 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Beck Anxiety Inventory (BAI) Score
|
6.57 score on a scale
Standard Deviation 9
|
2.4 score on a scale
Standard Deviation 4.48
|
SECONDARY outcome
Timeframe: Week 821-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=9 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=9 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Beck Anxiety Inventory (BAI) Score
|
6.67 score on a scale
Standard Deviation 8.60
|
4 score on a scale
Standard Deviation 6.24
|
SECONDARY outcome
Timeframe: Week 921-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=8 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=9 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Beck Anxiety Inventory (BAI) Score
|
6.125 score on a scale
Standard Deviation 9.46
|
1.89 score on a scale
Standard Deviation 2.80
|
SECONDARY outcome
Timeframe: Baseline21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=13 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=12 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Beck Depression Inventory (BDI) Score
|
9.92 score on a scale
Standard Deviation 7.89
|
9.25 score on a scale
Standard Deviation 7.19
|
SECONDARY outcome
Timeframe: Week 121-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=12 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=10 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Beck Depression Inventory (BDI) Score
|
7.83 score on a scale
Standard Deviation 6.39
|
7.2 score on a scale
Standard Deviation 7.64
|
SECONDARY outcome
Timeframe: Week 421-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=9 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=10 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Beck Depression Inventory (BDI) Score
|
9 score on a scale
Standard Deviation 7.07
|
5.2 score on a scale
Standard Deviation 7.67
|
SECONDARY outcome
Timeframe: Week 521-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=9 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=10 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Beck Depression Inventory (BDI) Score
|
7.67 score on a scale
Standard Deviation 6.89
|
5.1 score on a scale
Standard Deviation 8.94
|
SECONDARY outcome
Timeframe: Week 821-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=9 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=9 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Beck Depression Inventory (BDI) Score
|
7.67 score on a scale
Standard Deviation 7.57
|
4.67 score on a scale
Standard Deviation 6.10
|
SECONDARY outcome
Timeframe: Week 921-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.
Outcome measures
| Measure |
Phytocannabinoid Cannabidiol (CBD)
n=8 Participants
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
Placebo
n=9 Participants
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Beck Depression Inventory (BDI) Score
|
6.5 score on a scale
Standard Deviation 6.93
|
3.90 score on a scale
Standard Deviation 3.92
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Phytocannabinoid Cannabidiol (CBD)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=13 participants at risk
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
Phytocannabinoid Cannabidiol (CBD)
n=13 participants at risk
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Metabolism and nutrition disorders
Hospitalization for Ketoacidosis
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
Other adverse events
| Measure |
Placebo
n=13 participants at risk
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
|
Phytocannabinoid Cannabidiol (CBD)
n=13 participants at risk
600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).
|
|---|---|---|
|
Gastrointestinal disorders
Heartburn / Acid Reflux
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Psychiatric disorders
Memory Problems
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Psychiatric disorders
Depression
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
15.4%
2/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Gastrointestinal disorders
Loose Stool
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
General disorders
Drowsiness
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Skin and subcutaneous tissue disorders
Rash / Skin Irritation
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Infections and infestations
Flu
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Eye disorders
Pink Eye
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
General disorders
Chills
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Psychiatric disorders
Vivid Dreams
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Gastrointestinal disorders
Abdominal Pain
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
30.8%
4/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Respiratory, thoracic and mediastinal disorders
Runny Nose
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
15.4%
2/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Nervous system disorders
Headache
|
15.4%
2/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
23.1%
3/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
15.4%
2/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Gastrointestinal disorders
Diarrhea
|
15.4%
2/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
30.8%
4/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
General disorders
Fatigue
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
15.4%
2/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Metabolism and nutrition disorders
Appetite Increase
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
15.4%
2/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Gastrointestinal disorders
Increased Bowl Movement
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Musculoskeletal and connective tissue disorders
Body Ache
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
15.4%
2/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Infections and infestations
Gum Infection
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Infections and infestations
Fever
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
15.4%
2/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Cardiac disorders
Irregular Heartbeat
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Nervous system disorders
Light-Headedness
|
15.4%
2/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Nervous system disorders
Drowsy
|
15.4%
2/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Psychiatric disorders
Suicidal Ideation
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
23.1%
3/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Gastrointestinal disorders
Dry Mouth
|
15.4%
2/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
15.4%
2/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Gastrointestinal disorders
Gum Problems
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Gastrointestinal disorders
Stomach/Abdominal Discomfort
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Nervous system disorders
Taste Abnormality
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Psychiatric disorders
Cognitive Slowing
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Metabolism and nutrition disorders
Increased Thirst
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Gastrointestinal disorders
Queasiness
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Psychiatric disorders
Euphoria
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Psychiatric disorders
Perceptual Problems
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
15.4%
2/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Skin and subcutaneous tissue disorders
Hair Problems
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Psychiatric disorders
Feeling "High"
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
15.4%
2/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Psychiatric disorders
Perceptual Enhancement
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Respiratory, thoracic and mediastinal disorders
Relaxed Breathing
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
General disorders
Tiredness/Fatigue
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Hepatobiliary disorders
Elevated Heptic Enzymes
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Psychiatric disorders
Vivid Dreaming
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Psychiatric disorders
Increased Alcohol Craving
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
0.00%
0/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
|
Psychiatric disorders
Concentration Difficulty
|
7.7%
1/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
15.4%
2/13 • 12 Weeks
Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place