Effects of Kava on the Body's Elimination of Caffeine and Dextromethorphan
Status:
Completed
Trial end date:
2001-04-01
Target enrollment:
Participant gender:
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 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.
Phase:
Phase 4
Details
Lead Sponsor:
National Institutes of Health Clinical Center (CC)