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

NCT06072170 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 75F40121C00199 (FDU-P4-117)75F40121C00199
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Safety; Pharmacokinetics; Pharmacodynamics

Keywords

Kratom; Mitragynine; Botanical substance; Single Ascending Dose

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  For purposes of monitoring safety, treatment-emergent adverse events (AEs) will be graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (version 5.0).

  Day 1 through Day 7

Secondary Outcomes (11)

• Maximum Observed Concentration

  0, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 48.00 hours post-dose

• Time of Maximum Observed Concentration

  0, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 48.00 hours post-dose

• Area Under the Concentration Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-T)

  0, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 48.00 hours post-dose

• Area Under the Concentration Time Curve Extrapolated to Infinity

  0, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 48.00 hours post-dose

• Dose-normalized Cmax Calculated at Cmax / Dose

  0, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 48.00 hours post-dose

Study Arms (6)

Cohort 1, 1 g of Kratom

EXPERIMENTAL

A total of 6 subjects will receive an oral single dose administration of the active product

Drug: Kratom

Cohort 2, 3 g of Kratom

EXPERIMENTAL

A total of 6 subjects will receive an oral single dose administration of the active product

Drug: Kratom

Cohort 3, 8 g of Kratom

EXPERIMENTAL

A total of 6 subjects will receive an oral single dose administration of the active product

Drug: Kratom

Cohort 4, 10 g of Kratom

EXPERIMENTAL

A total of 6 subjects will receive an oral single dose administration of the active product

Drug: Kratom

Cohort 5, 12 g of Kratom

EXPERIMENTAL

A total of 6 subjects will receive an oral single dose administration of the active product

Drug: Kratom

Placebo

PLACEBO COMPARATOR

A total of 2 subjects per cohort will receive an oral single dose administration of placebo

Drug: Placebo

Interventions

Kratom DRUG

Single administration thirty minutes after the start of a high-fat breakfast

Cohort 1, 1 g of Kratom; Cohort 2, 3 g of Kratom; Cohort 3, 8 g of Kratom; Cohort 4, 10 g of Kratom; Cohort 5, 12 g of Kratom

Placebo DRUG

Single administration thirty minutes after the start of a high-fat breakfast

Placebo

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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
• 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:
• Is of childbearing potential and agrees to use an acceptable contraceptive method. Acceptable contraceptive methods include:
• a1. Abstinence from heterosexual intercourse from the Screening visit through to at least 30 days after study drug administration
• a2. One of the following contraceptive methods, used from at least 28 days prior to the Screening visit through to at least 30 days after study drug administration:
• Systemic contraceptives (combined birth control pills, injectable/implant/insertable hormonal birth control products, or transdermal patch)
• Intrauterine device (with or without hormones)

You may not qualify if:

• Difficulty swallowing capsules
• Female who is lactating
• 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)
• 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)
• 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)
• Regularly consumes excessive amounts of caffeine or xanthines, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day
• History of suicidal behavior within 2 years of Screening, showing suicidal tendency as per the C-SSRS administered at Screening, or is currently at risk of suicide in the opinion of an Investigator
• Estimated glomerular filtration rate (eGFR) ≤ 60 mL/min as calculated by the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation
• Any clinically significant illness in the 28 days prior to study drug administration
• Use of any prescription drugs (with the exception of hormonal contraceptives or hormone replacement therapy) in the 28 days prior to study drug administration, that in the opinion of an Investigator would put into question the status of the participant as healthy

Sponsors & Collaborators

• Altasciences Company Inc.: lead

Study Sites (1)

Altasciences Clinical Kansas, Inc.

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Interventions

mitragynine

Results Point of Contact

• Title: Senior Regulatory Affairs Associate
• Organization: Altasciences

mgalarza@altasciences.com

450 973 3155

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The treatment assignment (active or placebo) will not be known by the study participants. Study participants will be informed of the dose range they could receive but will not be informed of the actual dose assigned to them. Furthermore, the randomization code will not be available to the Investigator and clinical staff involved in the collection, monitoring, revision, or evaluation of AEs, as well as clinical staff who could have an impact on the outcome of the study including the pharmacokineticist (or delegate) and biostatistician, until all the case report form (CRFs) have been approved and signed and the bioanalytical phase of the study has been completed.
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: October 10, 2023
• Study Start: August 16, 2023
• Primary Completion: January 23, 2024
• Study Completion: January 23, 2024
• Last Updated: September 29, 2025
• Results First Posted: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)