NCT04565145

Biomarker Changes and Anxiolytic Effects-Phase 2

A Phased Clinical Trial of a Dietary Supplement Kava: Biomarker Changes and Anxiolytic Effects Phase 2: Kava Biomarker

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Kava Dietary Supplement	Participants will be given three 75mg kava capsules per day for one week
DRUG	Placebo	Participants will be given three placebo capsules per day for one week

Timeline

• Start date: 2021-04-05
• Primary completion: 2023-07-01
• Completion: 2023-07-01
• First posted: 2020-09-25
• Last updated: 2024-08-13
• Results posted: 2024-08-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study