Trial Outcomes & Findings for Biomarker Changes and Anxiolytic Effects-Phase 2 (NCT NCT04565145)
NCT ID: NCT04565145
Last Updated: 2024-08-13
Results Overview
The change in mean PRKACA value from pre to post-treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
From Baseline (pre dose) to 1 week after taking the first dose (post dose)
Results posted on
2024-08-13
Participant Flow
Individuals were recruited from flyers that were distributed in and around the Gainesville area and from the University of Florida (UF) Psychiatry and Psychology clinics.
Individuals were excluded it the met any of the exclusion criteria at screening or baseline.
Participant milestones
| Measure |
Kava Pharmacokinetics Group
75 mg kava dietary supplement capsules per day for one week.
Kava Dietary Supplement: Participants will be given three 75mg kava capsules per day for one week
|
Placebo
Three placebo capsule per day for one week
Placebo: Participants will be given three placebo capsules per day for one week
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Kava Pharmacokinetics Group
75 mg kava dietary supplement capsules per day for one week.
Kava Dietary Supplement: Participants will be given three 75mg kava capsules per day for one week
|
Placebo
Three placebo capsule per day for one week
Placebo: Participants will be given three placebo capsules per day for one week
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Biomarker Changes and Anxiolytic Effects-Phase 2
Baseline characteristics by cohort
| Measure |
Kava Pharmacokinetics Group
n=10 Participants
75 mg kava dietary supplement capsules per day for one week.
Kava Dietary Supplement: Participants will be given three 75mg kava capsules per day for one week
|
Placebo
n=10 Participants
Three placebo capsule per day for one week
Placebo: Participants will be given three placebo capsules per day for one week
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
26 years
n=5 Participants
|
23 years
n=7 Participants
|
25 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline (pre dose) to 1 week after taking the first dose (post dose)The change in mean PRKACA value from pre to post-treatment
Outcome measures
| Measure |
Kava Pharmacokinetics Group
n=10 Participants
75 mg kava dietary supplement capsules per day for one week.
Kava Dietary Supplement: Participants will be given three 75mg kava capsules per day for one week
|
Placebo
n=10 Participants
Three placebo capsule per day for one week
Placebo: Participants will be given three placebo capsules per day for one week
|
|---|---|---|
|
Mean PRKACA Change
Pre dose PRKACA
|
7224.56 relative fluorescence units
Standard Deviation 3526.22
|
5348.93 relative fluorescence units
Standard Deviation 2027.02
|
|
Mean PRKACA Change
Post dose PRKACA
|
6307.21 relative fluorescence units
Standard Deviation 5887.36
|
6495.7 relative fluorescence units
Standard Deviation 3757.65
|
Adverse Events
Kava Pharmacokinetics Group
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Kava Pharmacokinetics Group
n=10 participants at risk
75 mg kava dietary supplement capsules per day for one week.
Kava Dietary Supplement: Participants will be given three 75mg kava capsules per day for one week
|
Placebo
n=10 participants at risk
Three placebo capsule per day for one week
Placebo: Participants will be given three placebo capsules per day for one week
|
|---|---|---|
|
General disorders
Headache
|
20.0%
2/10 • Number of events 2 • 1 year and 6 months
Guidelines for reporting adverse events were the same as the clinical trials.gov definition.
|
10.0%
1/10 • Number of events 1 • 1 year and 6 months
Guidelines for reporting adverse events were the same as the clinical trials.gov definition.
|
|
General disorders
Dizziness
|
10.0%
1/10 • Number of events 1 • 1 year and 6 months
Guidelines for reporting adverse events were the same as the clinical trials.gov definition.
|
10.0%
1/10 • Number of events 1 • 1 year and 6 months
Guidelines for reporting adverse events were the same as the clinical trials.gov definition.
|
|
General disorders
Appetite loss
|
10.0%
1/10 • Number of events 1 • 1 year and 6 months
Guidelines for reporting adverse events were the same as the clinical trials.gov definition.
|
10.0%
1/10 • Number of events 1 • 1 year and 6 months
Guidelines for reporting adverse events were the same as the clinical trials.gov definition.
|
|
General disorders
Fatigue
|
20.0%
2/10 • Number of events 2 • 1 year and 6 months
Guidelines for reporting adverse events were the same as the clinical trials.gov definition.
|
0.00%
0/10 • 1 year and 6 months
Guidelines for reporting adverse events were the same as the clinical trials.gov definition.
|
|
General disorders
Chest tightness
|
0.00%
0/10 • 1 year and 6 months
Guidelines for reporting adverse events were the same as the clinical trials.gov definition.
|
10.0%
1/10 • Number of events 1 • 1 year and 6 months
Guidelines for reporting adverse events were the same as the clinical trials.gov definition.
|
|
General disorders
Brain fog
|
0.00%
0/10 • 1 year and 6 months
Guidelines for reporting adverse events were the same as the clinical trials.gov definition.
|
10.0%
1/10 • Number of events 1 • 1 year and 6 months
Guidelines for reporting adverse events were the same as the clinical trials.gov definition.
|
|
General disorders
Vivid dreams
|
0.00%
0/10 • 1 year and 6 months
Guidelines for reporting adverse events were the same as the clinical trials.gov definition.
|
10.0%
1/10 • Number of events 1 • 1 year and 6 months
Guidelines for reporting adverse events were the same as the clinical trials.gov definition.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place