PharmacokineticsPhase 2KavaPKNCT04565145
Biomarker Changes and Anxiolytic Effects-Phase 2
A Phase 2 study testing Kava Dietary Supplement in people with Pharmacokinetics, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Kava Dietary Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2021to 1 Jul 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
UF CTSI Clinical Research Center
Gainesville, Florida, 32610
About this study
Official title: 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.
Read the 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.
- Conditions
- Pharmacokinetics
- Being tested
- Kava Dietary Supplement, Placebo
- Keywords
- kava, dietary supplement, anxiety, generalized anxiety disorder (GAD)
- Medical subject headings
- Anxiety Disorders, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kava Dietary SupplementDrug
Also called Flavokavain AB-free kava
Participants will be given three 75mg kava capsules per day for one week
PlaceboDrug
Participants will be given three placebo capsules per day for one week
| Study group | Role | What they receive |
|---|---|---|
| Kava Pharmacokinetics Group | Experimental | 75 mg kava dietary supplement capsules per day for one week. Receives: Drug: Kava Dietary Supplement |
| Placebo | Placebo comparator | Three placebo capsule per day for one week Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean PRKACA Change
The change in mean PRKACA value from pre to post-treatment
Measured: From Baseline (pre dose) to 1 week after taking the first dose (post dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start5 Apr 2021
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Thorne HealthTech, Inc, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Carol Mathews, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565145
- Sponsor's protocol ID
- IRB202001129 -A
- Other IDs
- IRB201900074-N, 1R61AT009988-01A1, OCR36443, 3R61AT009988-02S1
- Acronym
- KavaPK
- Status last verified
- Jul 2024
- First submitted
- 14 Sep 2020
- Last updated
- 13 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phased Clinical Trial of a Dietary Supplement Kava: Biomarker Changes and Anxiolytic Effects Phase 2: Kava Biomarker
- ClinicalTrials.gov ID
- NCT04565145
- Acronym / sponsor ID
- KavaPK / IRB202001129 -A
- Conditions
- Pharmacokinetics
- Keywords
- kava, dietary supplement, anxiety, generalized anxiety disorder (GAD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Thorne HealthTech, Inc, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 25 Sep 2020 (actual)
- Results
- Posted 13 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kava Pharmacokinetics Group | Experimental | Drug: Kava Dietary Supplement75 mg kava dietary supplement capsules per day for one week. |
| Placebo | Placebo comparator | Drug: PlaceboThree placebo capsule per day for one week |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kava Dietary SupplementAlso: Flavokavain AB-free kavaParticipants will be given three 75mg kava capsules per day for one week | Drug | Kava Pharmacokinetics Group |
| PlaceboParticipants will be given three placebo capsules per day for one week | Drug | Placebo |
Primary outcome
Mean PRKACA Change
Time frame: From Baseline (pre dose) to 1 week after taking the first dose (post dose)
The change in mean PRKACA value from pre to post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol Mathews, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Kava Dietary Supplement in people with Pharmacokinetics, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean PRKACA Change (time frame: From Baseline (pre dose) to 1 week after taking the first dose (post dose)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.