Biomarker Changes and Anxiolytic Effects-Phase 2

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-05

Study Completion Date

2023-07-01

Brief Summary

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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.

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Detailed Description

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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

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Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Kava Pharmacokinetics Group

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

Group Type EXPERIMENTAL

Kava Dietary Supplement

Intervention Type DRUG

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

Placebo

Three placebo capsule per day for one week

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Kava Dietary Supplement

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Flavokavain AB-free kava

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes