Single Ascending Doses of Kratom in Healthy Nondependent Adults With Opioid Experience (NCT06072170) | Clinical Trial Compass
CompletedPhase 1
Single Ascending Doses of Kratom in Healthy Nondependent Adults With Opioid Experience
United States40 participantsStarted 2023-08-16
Plain-language summary
Kratom (Mitragyna speciosa) is a plant often used to self-treat conditions such as pain, coughing, diarrhea, anxiety and depression, opioid use disorder, and opioid withdrawal. Due to limited data availability, the goal of this clinical trial is to learn about safety, pharmacokinetics (what the body does to the drug) and pharmacodynamics (what the drug does to the body) of Kratom in adult recreational polydrug users with opioid experience.
Who can participate
Age range18 Years – 59 Years
SexALL
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Inclusion criteria
✓. Provision of signed and dated informed consent form (ICF)
✓. Stated willingness to comply with all study procedures and availability for the duration of the study
✓. Healthy adult male or female
✓. Current nondependent, polydrug recreational user who has used opioid drugs for recreational (nontherapeutic) purposes (i.e., for psychoactive effects) and has a history of recreational use of at least 2 or more of any of the perception-altering (e.g., lysergic acid diethylamide \[LSD\], kratom, cannabis, dronabinol, ketamine, phencyclidine \[PCP\], dextromethorphan, 3,4 methylenedioxymethamphetamine \[MDMA\], mescaline, psilocybin, tryptamine derivatives or ring-substituted amphetamines with perception altering effects) or stimulant (e.g., cocaine, amphetamine, methamphetamine, methylphenidate, methcathinone, and other synthetic cathinones) drugs
✓. If male, meets one of the following criteria:
✓. Is able to procreate and agrees to use one of the accepted contraceptive regimens and not to donate sperm from study drug administration to at least 90 days after study drug administration. An acceptable method of contraception includes one of the following:
✓. Is unable to procreate; defined as surgically sterile (i.e., has undergone a vasectomy at least 180 days prior to study drug administration)
✓. If female, meets one of the following criteria:
Exclusion criteria
✕. Difficulty swallowing capsules
✕
What they're measuring
1
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
✕. Female who is pregnant according to the pregnancy test at Screening or prior to study drug administration
✕. Male with female partner who is pregnant, lactating, or planning to become pregnant during this study or within 90 days after study drug administration
✕. History of significant hypersensitivity to kratom or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
✕. Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability with the exception of cholecystectomy that is permitted at the discretion of an Investigator
✕. History of significant hepatic, renal, cardiovascular, pulmonary, hematologic, neurological, psychiatric, gastrointestinal, endocrine, immunologic, ophthalmologic, or dermatologic disease
✕. Presence of any significant respiratory illness or presence or history of chronic respiratory disease (e.g., upper respiratory illness, sleep apnea, emphysema, asthma) at Screening (subjects with acute respiratory illness may be rescheduled upon resolution at the discretion of an Investigator)