NCT04565145

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

April 5, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 13, 2024

Completed
Last Updated

August 13, 2024

Status Verified

July 1, 2024

Enrollment Period

2.2 years

First QC Date

September 14, 2020

Results QC Date

May 2, 2024

Last Update Submit

July 23, 2024

Conditions

Pharmacokinetics

Keywords

kavadietary supplementanxietygeneralized anxiety disorder (GAD)

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

Kava Pharmacokinetics Group

EXPERIMENTAL

75 mg kava dietary supplement capsules per day for one week.

Drug: Kava Dietary Supplement

Placebo

PLACEBO COMPARATOR

Three placebo capsule per day for one week

Drug: Placebo

Interventions

Kava Dietary SupplementDRUG

Participants will be given three 75mg kava capsules per day for one week

Also known as: Flavokavain AB-free kava
Kava Pharmacokinetics Group
PlaceboDRUG

Participants will be given three placebo capsules per day for one week

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF CTSI Clinical Research Center

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Anxiety DisordersGeneralized Anxiety Disorder

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

Title
Robyn Nelson
Organization
University of Florida
r.nelson@ufl.edu
3522945563

Study Officials

  • Carol Mathews, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2020

First Posted

September 25, 2020

Study Start

April 5, 2021

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

August 13, 2024

Results First Posted

August 13, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)