SafetyPhase 1NCT06072170
Single Ascending Doses of Kratom in Healthy Nondependent Adults With Opioid Experience
A Phase 1 study testing Kratom in people with Safety and Pharmacokinetics, run by Altasciences Company Inc. at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety, Pharmacokinetics, Pharmacodynamics
- What is being tested?
- Kratom
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2023to 23 Jan 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
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- 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)
- Male partner vasectomized at least 6 months prior to the Screening visit
- a3. One of the following double-barrier contraceptive methods, used from the Screening visit through to at least 30 days study drug administration:
- Male condom plus spermicide
- Diaphragm plus spermicide
- Cervical cap plus spermicide
- Is of non-childbearing potential, defined as surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation), or is in a postmenopausal state (i.e., at least 1 year without menses without an alternative medical condition prior to the Screening visit and follicle stimulating hormone levels ≥ 40 mIU/mL at Screening)
- Body mass index (BMI) within 18.0 kg/m2 to 34.0 kg/m2, inclusively at Screening
- Minimum weight of 50.0 kg at Screening
- Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs, oxygen saturation [SpO2], and respiratory rate) and/or ECG, as determined by an Investigator
Who cannot join
- 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
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- 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
- Presence of clinically significant ECG abnormalities at the Screening visit, as defined by medical judgment. Note: QT corrected according to Fridericia's formula (QTcF) interval of > 450 msec in male subjects or > 470 msec in female subjects will be exclusionary. The ECG may be repeated once for confirmatory purposes if the initial value obtained exceeds the limits specified.
- 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
- Use of St. John's wort in the 28 days prior to study drug administration
- Positive test result for alcohol and/or drugs of abuse at admission (prior to study drug administration). Subjects with positive results at admission may be rescheduled at the discretion of an Investigator. If tetrahydrocannabinol (THC) is positive at admission a cannabis intoxication evaluation will be done by an Investigator and subjects may be permitted to continue in the study at the discretion of an Investigator. Other positive test results should be reviewed to determine if the subject may be rescheduled, in the opinion of the investigator.
- Positive screening results to HIV Ag/Ab combo, hepatitis B surface antigen or hepatitis C virus tests
- Any other clinically significant abnormalities in laboratory test results at Screening that would, in the opinion of an Investigator, increase the subject's risk of participation, jeopardize complete participation in the study, or compromise interpretation of study data
- Inclusion in a previous group for this clinical study
- Intake of kratom in the 14 days prior to study drug administration
- Intake of an Investigational Product (IP) in the 28 days prior to study drug administration
- Donation of plasma in the 7 days prior to study drug administration
- Donation of 1 unit of blood to American Red Cross or equivalent organization or donation of over 500 mL of blood in the 56 days prior to study drug administration
- Subject cannot eat dairy and/or is lactose intolerant
- Is, in the opinion of an Investigator or designee, considered unsuitable or unlikely to comply with the study protocol for any reason
Trial locations and contacts
1 site in 1 country.
United States1 site
Altasciences Clinical Kansas, Inc.
Overland Park, Kansas, 66212
About this study
Official title: 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
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.
Read the 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).
- Conditions
- Safety, Pharmacokinetics, Pharmacodynamics
- Being tested
- Kratom, Placebo
- Keywords
- Kratom, Mitragynine, Botanical substance, Single Ascending Dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KratomDrug
Single administration thirty minutes after the start of a high-fat breakfast
PlaceboDrug
Single administration thirty minutes after the start of a high-fat breakfast
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1, 1 g of Kratom | Experimental | A total of 6 subjects will receive an oral single dose administration of the active product Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Kratom |
| Placebo | Placebo comparator | A total of 2 subjects per cohort will receive an oral single dose administration of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 1 through Day 7
Secondary outcomes (11)
Maximum Observed Concentration
Cmax (ng/mL) will be evaluated for: mitragynine, 7 hydroxy-mitragynine, paynantheine, speciogynine, and speciociliatine
Measured: 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
Tmax (hours) will be evaluated for: mitragynine, 7 hydroxy-mitragynine, paynantheine, speciogynine, and speciociliatine
Measured: 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)
AUC0-T (ng*h/mL) will be evaluated for: mitragynine, 7 hydroxy-mitragynine, paynantheine, speciogynine, and speciociliatine
Measured: 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
AUC0-inf (ng*h/mL) will be evaluated for: mitragynine, 7 hydroxy-mitragynine, paynantheine, speciogynine, and speciociliatine
Measured: 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
Cmax/D (ng/mL/g) will be evaluated for: mitragynine, 7 hydroxy-mitragynine, paynantheine, speciogynine, and speciociliatine
Measured: 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 AUC0-T Calculated as AUC0-T / Dose
AUC0-T/D (ng*h/mL/g) will be evaluated for: mitragynine, 7 hydroxy-mitragynine, paynantheine, speciogynine, and speciociliatine
Measured: 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 AUC0-inf Calculated as AUC0-inf / Dose
AUC0-inf/D (ng*h/mL/g) will be evaluated for: mitragynine, 7 hydroxy-mitragynine, paynantheine, speciogynine, and speciociliatine
Measured: 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
Maximum Effect for Drug Liking
Maximum (peak) effect (Emax) for Drug Liking assessed on a bipolar (0 to 100 points) visual analog scale (VAS). Anchors will be presented using text such as "strong disliking" (score = 0), "neither like nor dislike" (score = 50) to "strong liking" (score = 100).
Measured: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose
Maximum Effect for Overall Drug Liking
Maximum (peak) effect (Emax) for Overall Drug Liking assessed on a bipolar (0 to 100 points) visual analog scale (VAS). Anchors will be presented using text such as "strong disliking" (score = 0), "neither like nor dislike" (score = 50) to "strong liking" (score = 100).
Measured: 12 and 24 hours postdose
Maximum Effect for Take Drug Again
Maximum (peak) effect (Emax) for Take Drug Again assessed on a bipolar (0 to 100 points) visual analog scale (VAS). Anchors will be presented using text such as "definitely would not" (score = 0), "neither would nor would not" (score = 50) to "definitely would" (score = 100).
Measured: 12 and 24 hours postdose
Maximum Effect for High
Maximum (peak) effect (Emax) for High assessed on an unipolar (0 to 100 points) visual analog scale (VAS). Anchors will be presented using text such as "not at all" (score = 0) to "extremely" (score = 100).
Measured: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start16 Aug 2023
- Primary completion23 Jan 2024
- Study completion23 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altasciences Company Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072170
- Sponsor's protocol ID
- 75F40121C00199 (FDU-P4-117)
- Other IDs
- 75F40121C00199
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2023
- Last updated
- 29 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06072170
- Acronym / sponsor ID
- 75F40121C00199 (FDU-P4-117)
- Conditions
- Safety, Pharmacokinetics, Pharmacodynamics
- Keywords
- Kratom, Mitragynine, Botanical substance, Single Ascending Dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Altasciences Company Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 23 Jan 2024 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Posted 29 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1, 1 g of Kratom | Experimental | Drug: KratomA total of 6 subjects will receive an oral single dose administration of the active product |
| Cohort 2, 3 g of Kratom | Experimental | Drug: KratomA total of 6 subjects will receive an oral single dose administration of the active product |
| Cohort 3, 8 g of Kratom | Experimental | Drug: KratomA total of 6 subjects will receive an oral single dose administration of the active product |
| Cohort 4, 10 g of Kratom | Experimental | Drug: KratomA total of 6 subjects will receive an oral single dose administration of the active product |
| Cohort 5, 12 g of Kratom | Experimental | Drug: KratomA total of 6 subjects will receive an oral single dose administration of the active product |
| Placebo | Placebo comparator | Drug: PlaceboA total of 2 subjects per cohort will receive an oral single dose administration of placebo |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (24 listed)
- 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:
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KratomSingle administration thirty minutes after the start of a high-fat breakfast | Drug | 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 |
| PlaceboSingle administration thirty minutes after the start of a high-fat breakfast | Drug | Placebo |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day 1 through Day 7
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).
11 secondary outcomes
Maximum Observed Concentration
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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 AUC0-T Calculated as AUC0-T / Dose
Time frame: 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 AUC0-inf Calculated as AUC0-inf / Dose
Time frame: 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
Maximum Effect for Drug Liking
Time frame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose
Maximum Effect for Overall Drug Liking
Time frame: 12 and 24 hours postdose
Maximum Effect for Take Drug Again
Time frame: 12 and 24 hours postdose
Maximum Effect for High
Time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Kratom in people with Safety and Pharmacokinetics, run by Altasciences Company Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: Day 1 through Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.