HealthyPhase 4NCT00009542
Effects of Kava on the Body's Elimination of Caffeine and Dextromethorphan
A Phase 4 study testing kava (Piper methysticum) in people with Healthy, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
This study will examine how kava-a widely used herbal remedy-may affect the body's elimination of other medicines. Many people take kava to reduce anxiety or cause sedation. Since this product is considered a food supplement and not a drug, it is not subject to the rigorous pre-market testing required for prescription… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- kava (Piper methysticum)
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2001to Apr 2001
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Male or female
Healthy by medical history and physical exam
Age greater than 21 years old
No concurrent medications
Non-smoker (for at least 6 months if prior history of smoking)
Laboratory values within the following guidelines:
AST/SGOT less than or equal 1.5 X ULN
Bilirubin less than or equal 1.5 X ULN
Serum creatinine less than or equal ULN
Hemoglobin less than 10 g/dl
Females of child bearing potential must be using a reliable form of birth control other than hormonal contraceptives
Ability to abstain from caffeine containing foods/beverages, ethanol, grapefruit or grapefruit juice and charbroiled foods for 72 hours prior to, and the day of, phenotyping procedures.
Normal EEG during baseline testing.
No patients using concomitant therapy with other inhibitors or inducers of cytochrome P-450 mediated drug metabolism within 30 days of study.
No patients with inability to remain free of chronic medications and alcohol for atleast 2 weeks prior to and during the study.
Presence of renal, hepatic, cardiovascular, hematologic, neurologic, psychiatric, or respiratory disease or any other condition that may interfere with the interpretation of the study results or not be in the best interests of the subject in the opinion of the investigator.
Positive urine pregnancy test.
The presence of persistent diarrhea or malabsorption that would interfere with the patient's ability to adequately absorb drug.
Drug or alcohol use that may impair safety or adherence.
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, 20892
About this study
Official title: Evaluation of the Effect of Kava on Drug Metabolism Enzymes and EEG Measured Beta Amplitude
This study will examine how kava-a widely used herbal remedy-may affect the body's elimination of other medicines. Many people take kava to reduce anxiety or cause sedation. Since this product is considered a food supplement and not a drug, it is not subject to the rigorous pre-market testing required for prescription and over-the-counter (OTC) drugs. As a result, information has not been collected on possible interactions between kava and other medications. This study will look at how kava affects the elimination of caffeine-a compound commonly found in chocolate, coffee, tea and soft drinks-and dextromethorphan-an OTC cough suppressant.
Normal healthy volunteers 21 years of age or older may be eligible for this 30-day study. Candidates will provide a medical history and undergo a physical examination and routine blood tests. Women of childbearing age will have a urine pregnancy test.
Read more
Study participants will not drink alcoholic beverages or take any medications (except those given in the study) for 2 weeks prior to the study and throughout its duration. In addition, they will abstain from caffeine, grapefruit and grapefruit juice and charbroiled foods for at least 72 hours before and throughout each study day that urine is collected.
On day 1 of the study, study subjects will take one dose each of caffeine and dextromethorphan at 4:00 P.M.. They will empty their bladder before the dosing and then collect all their urine after the dosing for the rest of the day and including the next mornings first urine. They will bring the urine samples to the Clinical Center when the collection is complete. This procedure will be repeated 1 week later (study day 8). After the second urine collection is completed, subjects will take 200 milligrams of kava 3 times a day for 21 days. On study day 29 (after 21 days of kava), subjects will repeat the dextromethorphan and caffeine dosing and urine collection described above, while continuing to take kava.
Subjects will have an electroencephalograph (EEG) done before starting kava and again at the end of kava (study day 30). For this procedure, several electrodes (metal cups attached to wires) are secured to the scalp with a glue-like substance. A conductive gel fills the space between the electrode and the scalp to ensure good contact. The electrodes will remain in place for about 2 hours and then removed. The subject lies quietly on a bed during the EEG recording.
Participation in the study will end with another physical examination and blood tests following the second EEG and urine collection.
Read the detailed description
Kava (piper methysticum) is a complementary or alternative medication used for purported anxiolytic and sedative effects. Despite its widespread use there is no data regarding potential for drug interactions or its effects on the electroencephalogram. The purpose of this study is to determine the effect of administration of kava for 3 weeks on the activity of cytochrome p450, 1A2, 2D6, 3A4; NAT2, and XO. Additionally, the effect of kava on EEG measured beta amplitude will be evaluated. Fifteen healthy volunteers will undergo enzyme activity phenotyping by ingesting 2 mg/kg of caffeine and 30 mg of dextromethorphan followed by an overnight urine collection. Following completion of two separate baseline evaluations, separated by 1 week, subjects will then take 1 capsule containing 60 mg of kavalactones three times daily for 3 weeks. Following 3 weeks of therapy subjects will undergo repeat enzyme activity phenotyping as described previously. Enzyme activity following 3 weeks of kava will be compared to pre-treatment values to characterize the magnitude of inhibition and/or induction of CYP1A2, CYP2D6, CYP3A4, NAT2, and XO activity. Additionally, subjects will have EEG testing performed to evaluate the effect of kava on beta amplitude. EEG's will be performed the day before the first baseline phenotyping procedure and then following three weeks of kava (the day before the final phenotyping procedure). Beta amplitude following three weeks of kava will be compared to pre-treatment values to evaluate the magnitude of pharmacodynamic effect. The results of this study will be used to facilitate the development of protocols to evaluate the magnitude of interactions between clinically relevant traditional medications and kava as well as studies to compare the pharmacologic effect of kava to the effects of benzodiazepines.
- Conditions
- Healthy
- Being tested
- kava (Piper methysticum)
- Keywords
- Caffeine, Cytochrome P 450, Dextromethorphan, Herbal, Interactions, Alternative Therapy, Healthy Volunteer, Kava
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kava (Piper methysticum)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startJan 2001
- Study completionApr 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00009542
- Sponsor's protocol ID
- 010059
- Other IDs
- 01-CC-0059
- Status last verified
- Jan 2001
- First submitted
- 27 Jan 2001
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Elion RA, Cohen C. Complementary medicine and HIV infection. Prim Care. 1997 Dec;24(4):905-19. doi: 10.1016/s0095-4543(05)70316-x.
PubMed 9386262Israel D, Youngkin EQ. Herbal therapies for perimenopausal and menopausal complaints. Pharmacotherapy. 1997 Sep-Oct;17(5):970-84.
PubMed 9324185Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, Van Rompay M, Kessler RC. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA. 1998 Nov 11;280(18):1569-75. doi: 10.1001/jama.280.18.1569.
PubMed 9820257
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Kava on Drug Metabolism Enzymes and EEG Measured Beta Amplitude
- ClinicalTrials.gov ID
- NCT00009542
- Acronym / sponsor ID
- 010059
- Conditions
- Healthy
- Keywords
- Caffeine, Cytochrome P 450, Dextromethorphan, Herbal, Interactions, Alternative Therapy, Healthy Volunteer, Kava
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- Jan 2001
- Study completion
- Apr 2001
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
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 how kava-a widely used herbal remedy-may affect the body's elimination of other medicines. Many people take kava to reduce anxiety or cause sedation. Since this product is considered a food supplement and not a drug, it is not subject to the rigorous pre-market testing required for prescription and over-the-counter (OTC) drugs. As a result, information has not been collected on possible interactions between kava and other medications. This study will look at how kava affects the elimination of caffeine-a compound commonly found in chocolate, coffee, tea and soft drinks-and dextromethorphan-an OTC cough suppressant.
Normal healthy volunteers 21 years of age or older may be eligible for this 30-day study. Candidates will provide a medical history and undergo a physical examination and routine blood tests. Women of childbearing age will have a urine pregnancy test.
Study participants will not drink alcoholic beverages or take any medications (except those given in the study) for 2 weeks prior to the study and throughout its duration. In addition, they will abstain from caffeine, grapefruit and grapefruit juice and charbroiled foods for at least 72 hours before and throughout each study day that urine is collected.
On day 1 of the study, study subjects will take one dose each of caffeine and dextromethorphan at 4:00 P.M.. They will empty their bladder before the dosing and then collect all their urine after the dosing for the rest of the day and including the next mornings first urine. They will bring the urine samples to the Clinical Center when the collection is complete. This procedure will be repeated 1 week later (study day 8). After the second urine collection is completed, subjects will take 200 milligrams of kava 3 times a day for 21 days. On study day 29 (after 21 days of kava), subjects will repeat the dextromethorphan and caffeine dosing and urine collection described above, while continuing to take kava.
Subjects will have an electroencephalograph (EEG) done before starting kava and again at the end of kava (study day 30). For this procedure, several electrodes (metal cups attached to wires) are secured to the scalp with a glue-like substance. A conductive gel fills the space between the electrode and the scalp to ensure good contact. The electrodes will remain in place for about 2 hours and then removed. The subject lies quietly on a bed during the EEG recording.
Participation in the study will end with another physical examination and blood tests following the second EEG and urine collection.
Detailed description
Kava (piper methysticum) is a complementary or alternative medication used for purported anxiolytic and sedative effects. Despite its widespread use there is no data regarding potential for drug interactions or its effects on the electroencephalogram. The purpose of this study is to determine the effect of administration of kava for 3 weeks on the activity of cytochrome p450, 1A2, 2D6, 3A4; NAT2, and XO. Additionally, the effect of kava on EEG measured beta amplitude will be evaluated. Fifteen healthy volunteers will undergo enzyme activity phenotyping by ingesting 2 mg/kg of caffeine and 30 mg of dextromethorphan followed by an overnight urine collection. Following completion of two separate baseline evaluations, separated by 1 week, subjects will then take 1 capsule containing 60 mg of kavalactones three times daily for 3 weeks. Following 3 weeks of therapy subjects will undergo repeat enzyme activity phenotyping as described previously. Enzyme activity following 3 weeks of kava will be compared to pre-treatment values to characterize the magnitude of inhibition and/or induction of CYP1A2, CYP2D6, CYP3A4, NAT2, and XO activity. Additionally, subjects will have EEG testing performed to evaluate the effect of kava on beta amplitude. EEG's will be performed the day before the first baseline phenotyping procedure and then following three weeks of kava (the day before the final phenotyping procedure). Beta amplitude following three weeks of kava will be compared to pre-treatment values to evaluate the magnitude of pharmacodynamic effect. The results of this study will be used to facilitate the development of protocols to evaluate the magnitude of interactions between clinically relevant traditional medications and kava as well as studies to compare the pharmacologic effect of kava to the effects of benzodiazepines.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 (Piper methysticum) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 9386262Elion RA, Cohen C. Complementary medicine and HIV infection. Prim Care. 1997 Dec;24(4):905-19. doi: 10.1016/s0095-4543(05)70316-x.
- Background: PubMed 9324185Israel D, Youngkin EQ. Herbal therapies for perimenopausal and menopausal complaints. Pharmacotherapy. 1997 Sep-Oct;17(5):970-84.
- Background: PubMed 9820257Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, Van Rompay M, Kessler RC. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA. 1998 Nov 11;280(18):1569-75. doi: 10.1001/jama.280.18.1569.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing kava (Piper methysticum) in people with Healthy, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00009542, which also lists 3 linked publications.
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 4 Mar 2008.