Biomarker Changes and Anxiolytic Effects-Phase 2 (KavaPK)

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

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.

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics
• Intervention / Treatment: Drug: Kava Dietary Supplement; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • UF CTSI Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults ages 18-50 who meet Diagnostic Statistical Manual (DSM)-5 criteria for GAD as the primary psychiatric diagnosis
• No more than one failed therapeutic trial of an FDA approved medication for the treatment of GAD
• Score of>14 on the Hamilton Anxiety Rating Scale at both screening and baseline
• At least a 4 (moderate) on the Clinical Global Impressions Severity Scale at both screening and baseline
• Females of potential childbearing status must use adequate contraceptive precautions.

Exclusion Criteria:

• Unwilling/unable/unsafe to stop psychotropic medications (if on any) for the duration of the study
• Inability to refrain from acetaminophen, alcohol or other potentially hepatotoxic substances
• History of liver disease or current liver disease or clinically significant elevation in serum liver chemistries
• Unstable medical or neurological condition
• Positive urine drug screen for substances of abuse
• Active substance abuse/dependence
• Lifetime history of a psychotic disorder, bipolar disorder, PTSD or Obsessive Compulsive Disorder
• Any significant risk for self-harm or suicidality as determined by the principal investigator or suicide attempt within the last 6 months
• Psychotherapy newly instituted during the 6 weeks leading up to enrollment in the study. Subjects established in psychotherapy without change during the course of the study may participate
• Montgomery-Asberg Depression Rating Scale (MADRS) > 17 (moderate or severe depressive symptoms)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kava Pharmacokinetics Group; 75 mg kava dietary supplement capsules per day for one week.	Drug: Kava Dietary Supplement; Participants will be given three 75mg kava capsules per day for one week; Other Names: Flavokavain AB-free kava
Placebo Comparator: Placebo; Three placebo capsule per day for one week	Drug: Placebo; Participants will be given three placebo capsules per day for one week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean PRKACA Change	The change in mean PRKACA value from pre to post-treatment	From Baseline (pre dose) to 1 week after taking the first dose (post dose)

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); Thorne HealthTech, Inc
• Investigators: Principal Investigator: Carol Mathews, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2021
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: September 14, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: anxiety; dietary supplement; kava; generalized anxiety disorder (GAD)
• Other Study ID Numbers: IRB202001129 -A; 1R61AT009988-01A1 (U.S. NIH Grant/Contract); 3R61AT009988-02S1 (U.S. NIH Grant/Contract); IRB201900074-N (Other Identifier: UF IRB (Phase I)); OCR36443 (Other Identifier: UF OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No