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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 depre…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean PRKACA Change
Timeframe: From Baseline (pre dose) to 1 week after taking the first dose (post dose)