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Single Ascending Doses of Kratom in Healthy Nondependent Adults With Opioid Experience | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Single Ascending Doses of Kratom in Healthy Nondependent Adults With Opioid Experience

Adaptive Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Kratom in Healthy, Nondependent, Adult Recreational Polydrug Users With Opioid Experience

NCT06072170•Altasciences Company Inc.

View on ClinicalTrials.gov

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.

Detailed Description

This is a phase I, single-dose, randomized, adaptive, double-blind, placebo-controlled, single ascending dose (SAD), sequential group study in adult recreational polydrug users with opioid experience performed at a single study center. This study will consist of five cohorts. Forty subjects are planned to participate. Eight subjects will participate in each cohort. Within each cohort, 6 subjects will be randomized to receive Kratom and 2 subjects will be randomized to receive placebo. Each subject will be involved in the study for up to approximately 37 days (including screening).

Eligibility

Age

18 - 59 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Provision of signed and dated informed consent form (ICF)
•2. Stated willingness to comply with all study procedures and availability for the duration of the study
•3. Healthy adult male or female
•4. 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
•5. If male, meets one of the following criteria:
•1. 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:
•* Abstinence from heterosexual intercourse
•* Double-barrier method (e.g., male condom with spermicide or male condom with a vaginal spermicide \[gel, foam, or suppository\]) Or
•2. Is unable to procreate; defined as surgically sterile (i.e., has undergone a vasectomy at least 180 days prior to study drug administration)
•6. If female, meets one of the following criteria:
+14 more criteria

Exclusion Criteria

•1. Difficulty swallowing capsules
•2. Female who is lactating
•3. Female who is pregnant according to the pregnancy test at Screening or prior to study drug administration
•4. Male with female partner who is pregnant, lactating, or planning to become pregnant during this study or within 90 days after study drug administration
•5. 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
•6. 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
•7. History of significant hepatic, renal, cardiovascular, pulmonary, hematologic, neurological, psychiatric, gastrointestinal, endocrine, immunologic, ophthalmologic, or dermatologic disease
•8. 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)
•9. History of substance or alcohol moderate to severe use disorder (excluding nicotine and caffeine) within the past 2 years, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)
•10. Is a heavy smoker (\> 20 cigarettes per day) and/or is unable to abstain from smoking or unable to abstain from the use of prohibited nicotine-containing products for at least 1 hour before and 8 hours after study drug administration (including e-cigarettes, pipes, cigars, chewing tobacco, nicotine topical patches, nicotine gum, or nicotine lozenges)
+17 more criteria

Locations (1)

Altasciences Clinical Kansas, Inc.

Overland Park, Kansas, United States

Key Dates

Start Date

August 16, 2023

Primary Completion Date

January 23, 2024

Completion Date

January 23, 2024

Last Updated

September 29, 2025

Enrollment

ACTUAL participants

Conditions

SafetyPharmacokineticsPharmacodynamics

Interventions

Kratom

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Single Ascending Doses of Kratom in Healthy Nondependent Adults With Opioid Experience

Inclusion Criteria

Exclusion Criteria

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