Trial Outcomes & Findings for A Clinical Trial of a Hemp-Derived Cannabidiol Product for Anxiety (NCT NCT04286594)
NCT ID: NCT04286594
Last Updated: 2024-08-27
Results Overview
The BAI is a 21-item self-report measure used to rate subjective, somatic, and panic-related symptoms of anxiety on a scale of 0 to 3, and will be given to participants on a weekly basis. The possible range of scores is 0-63.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
6 weeks
Results posted on
2024-08-27
Participant Flow
3 participants were excluded from the study before completing the baseline visit; n=2 were excluded due to meeting specific exclusion criteria, and n=1 was excluded after the participant signed out of the remote baseline visit and could not be recontacted to continue.
Participant milestones
| Measure |
CBD Treatment
0.5ml of sublingual CBD solution (30mg/ml) administered twice daily for six weeks.
CBD: Participants will receive CBD solution during the open-label phase of the trial.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Trial of a Hemp-Derived Cannabidiol Product for Anxiety
Baseline characteristics by cohort
| Measure |
CBD Treatment
n=12 Participants
0.5ml of sublingual CBD solution (30mg/ml) administered twice daily for six weeks.
CBD: Participants will receive CBD solution during the open-label phase of the trial.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38.000 Years
STANDARD_DEVIATION 12.143 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksThe BAI is a 21-item self-report measure used to rate subjective, somatic, and panic-related symptoms of anxiety on a scale of 0 to 3, and will be given to participants on a weekly basis. The possible range of scores is 0-63.
Outcome measures
| Measure |
CBD Treatment
n=12 Participants
0.5ml of sublingual CBD solution (30mg/ml) administered twice daily for six weeks.
CBD: Participants will receive CBD solution during the open-label phase of the trial.
|
|---|---|
|
Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI)
Baseline BAI Score
|
16.667 Score on a scale
Standard Deviation 5.598
|
|
Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI)
1-Week BAI Score
|
7.917 Score on a scale
Standard Deviation 4.010
|
|
Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI)
2-Week BAI Score
|
5.500 Score on a scale
Standard Deviation 3.289
|
|
Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI)
3-Week BAI Score
|
5.250 Score on a scale
Standard Deviation 3.519
|
|
Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI)
4-Week BAI Score
|
6.333 Score on a scale
Standard Deviation 5.105
|
|
Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI)
5-Week BAI Score
|
5.727 Score on a scale
Standard Deviation 5.274
|
|
Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI)
6-Week BAI Score
|
5.000 Score on a scale
Standard Deviation 4.023
|
Adverse Events
CBD Treatment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CBD Treatment
n=12 participants at risk
0.5ml of sublingual CBD solution (30mg/ml) administered twice daily for six weeks.
CBD: Participants will receive CBD solution during the open-label phase of the trial.
|
|---|---|
|
Reproductive system and breast disorders
Decreased libido
|
8.3%
1/12 • Number of events 1 • Adverse events were assessed throughout the 6-week treatment period.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1 • Adverse events were assessed throughout the 6-week treatment period.
|
|
General disorders
Weight gain
|
8.3%
1/12 • Number of events 1 • Adverse events were assessed throughout the 6-week treatment period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place