Biomarker Changes and Anxiolytic Effects-Phase 2

Pharmacokinetics Clinical Trial

— KavaPK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04565145
• Other study ID #: IRB202001129 -A
• Secondary ID: IRB201900074-N1R
• Status: Completed
• Phase: Phase 2
• Start date: April 5, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: January 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Adults ages 18-50 who meet 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 OCD

• 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)

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• Kava Dietary Supplement
Participants will be given three 75mg kava capsules per day for one week
• Placebo
Participants will be given three placebo capsules per day for one week

Locations

Country	Name	City	State
United States	UF CTSI Clinical Research Center	Gainesville	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Florida	National Center for Complementary and Integrative Health (NCCIH), Thorne HealthTech, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean PRKACA change to validate PRKACA change %	To measure the mean PRKACA change to validate PRKACA change % of biomarkers	From Baseline up to Study Completion Date, an average of 1 year