A Phase 2 interventional study of Kava Dietary Supplement and Placebo in Pharmacokinetics, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-13.
Sponsored by University of Florida · Phase 2, Interventional, and Treatment
This study will examine the utility of plasma and urinary based biomarkers for the anxiolytic properties of kava. The investigators will conduct a one week, double blind, randomized placebo controlled trial of kava, dosed at three 75 mg capsules per day, vs placebo, in adults with generalized anxiety disorder.
This study will examine the utility of plasma and urinary based biomarkers for the anxiolytic properties of kava, a natural dietary supplement. The investigators will conduct a one week, double blind, randomized placebo controlled trial of kava, dosed at three 75 mg capsules per day, vs placebo, in adults with generalized anxiety disorder. Clinical measures of anxiety, blood, and urine will be obtained. Biomarkers of interest include PRKACA, cortisol, urinary TCE, and NA5HT. Participants will be assessed pre- and post-treatment. The participants will also be followed for 12 weeks after the end of treatment to identify any potential rare adverse events, particularly liver toxicity, that appear in a delayed fashion.
5,063 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.
This study's enrollment of 39 is below the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →University of Florida is the lead sponsor of 1,285 studies on the registry; 199 are open to participants now.
Of its 177 completed or terminated interventional studies of FDA-regulated products, 141 (80%) have results posted.
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Exclusion Criteria:
75 mg kava dietary supplement capsules per day for one week.
Drug: Kava Dietary Supplement
Three placebo capsule per day for one week
Drug: Placebo
Participants will be given three 75mg kava capsules per day for one week
Also known as: Flavokavain AB-free kava
Participants will be given three placebo capsules per day for one week
Mean PRKACA Change
The change in mean PRKACA value from pre to post-treatment
Time frame: From Baseline (pre dose) to 1 week after taking the first dose (post dose)
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.
| Milestone | Kava Pharmacokinetics Group | Placebo |
|---|---|---|
| Started | 10 | 10 |
| Completed | 9 | 9 |
| Not completed | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
The change in mean PRKACA value from pre to post-treatment
| relative fluorescence units | Kava Pharmacokinetics Group | Placebo |
|---|---|---|
| Pre dose PRKACA | 7224.56 ± 3526.22 | 5348.93 ± 2027.02 |
| Post dose PRKACA | 6307.21 ± 5887.36 | 6495.7 ± 3757.65 |
Collected over 1 year and 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Kava Pharmacokinetics Group | 0/10 (0%) | 0/10 (0%) | 4/10 (40%) |
| Placebo | 0/10 (0%) | 0/10 (0%) | 3/10 (30%) |
| Event | Kava Pharmacokinetics Group | Placebo |
|---|---|---|
| HeadacheGeneral disorders | 2/10 | 1/10 |
| FatigueGeneral disorders | 2/10 | 0/10 |
| DizzinessGeneral disorders | 1/10 | 1/10 |
| Appetite lossGeneral disorders | 1/10 | 1/10 |
| Chest tightnessGeneral disorders | 0/10 | 1/10 |
| Brain fogGeneral disorders | 0/10 | 1/10 |
| Vivid dreamsGeneral disorders | 0/10 | 1/10 |
Participants were enrolled and analyzed as described in the protocol
| Age, Categorical(Participants) | Kava Pharmacokinetics Group | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 10 | 20 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Kava Pharmacokinetics Group | Placebo | Total |
|---|---|---|---|
| Median | 26 (19 to 50) | 23 (18 to 37) | 25 (18 to 50) |
| Sex: Female, Male(Participants) | Kava Pharmacokinetics Group | Placebo | Total |
|---|---|---|---|
| Female | 9 | 7 | 16 |
| Male | 1 | 3 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Kava Pharmacokinetics Group | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 3 | 4 |
| Not Hispanic or Latino | 9 | 7 | 16 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Kava Pharmacokinetics Group | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 9 | 7 | 16 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Kava Pharmacokinetics Group | Placebo | Total |
|---|---|---|---|
| United States | 10 | 10 | 20 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Apr 2021 to primary completion in Jul 2023, 26 months.
Results were first posted in Aug 2024, 1 year 1 month after primary completion.
Of 65 non-industry phase 2 interventional studies under Anxiety Disorders, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's 26 months is below that.
Counting every sponsor, half of 81 studies reached it within 34 months; a quarter within 16 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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