Assessing the Pharmacokinetics and Drug... — Clinical Trial Details

Participants

Ages

18 – 55

Sexes

Male & Female

BMI

Psychosis History

Not taking any medications (prescription and non-prescription) or dietary/herbal supplements known to alter the pharmacokinetics of either study drug or kratom constituents
Willing to abstain from consuming dietary/herbal supplements, including kratom, and citrus juices for several weeks
Willing to abstain from consuming caffeinated beverages or other caffeine-containing products the evening before and morning of the first day of a study arm
Willing to abstain from consuming any alcoholic beverages for one day prior to any study day, during the 14-hour inpatient days, and for the 5 and/or 1 outpatient visit(s) following 14-hour visit
Willing to use an acceptable method of contraception that does not include oral contraceptive pills or patches (such as abstinence, copper IUD, condom)
Have the time to participate
Are non-naïve kratom users (intermittent users who are not trying to quit but willing to abstain for several weeks)
Carry a CYP2D6 genotype designated as having an intermediate, extensive, or ultra-extensive metabolizer phenotype
Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for the subject to comply with the requirements of the study

Men and women under the age of 18 or over the age of 55
Unwilling to abstain from kratom for several weeks
Any current major illness or chronic illness such as (but not limited to) kidney disease, hepatic disease, diabetes mellitus, hypertension, coronary artery disease, chronic obstructive pulmonary disease, cancer, or HIV/AIDS
History of anemia or any other significant hematologic disorder
History of drug or alcohol addiction or major psychiatric illness
A need for chronic opioid analgesics
Use of opioid analgesics 3 weeks prior to initiation of the study
An imminent likely need for opioid analgesics (e.g., planned dental or surgical procedure)
Female and pregnant or nursing
Have a history of allergy to dextromethorphan, midazolam, or related drugs
Have a history of intolerance or allergy to kratom or opioids
Taking concomitant medications, both prescription and non-prescription (including dietary supplements/herbal products), known to alter the pharmacokinetics of either study drug or kratom constituents
Carry a CYP2D6 genotype designated as having a poor metabolizer phenotype
Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data

Assessing the Pharmacokinetics and Drug Interaction Liability of Kratom, an Opioid-like Natural Product