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Kratom for Opioid Experience

Phase 1
Waitlist Available
Research Sponsored by Altasciences Company Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

Study Summary

This trial will study the safety, absorption, and effects of Kratom on adults with opioid experience who use multiple drugs recreationally.

Who is the study for?
This trial is for healthy adults who have used opioids recreationally at least once in the past 12 weeks and other drugs on several occasions. Participants must not be dependent on substances, able to use effective contraception, and free from significant health issues or surgeries affecting drug absorption.Check my eligibility
What is being tested?
The study tests Kratom's safety and how it affects and is processed by the body compared to a placebo. It targets recreational polydrug users with opioid experience to understand its potential therapeutic uses for conditions like pain or opioid withdrawal.See study design
What are the potential side effects?
Potential side effects of Kratom are not fully known due to limited data but may include nausea, itching, dry mouth, increased urination, constipation, loss of appetite, seizures, hallucinations or psychosis when used in large doses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Secondary outcome measures
Area under the concentration time curve extrapolated to infinity
Area under the concentration time curve from time zero to the time of last quantifiable concentration (AUC0-T)
Dose-normalized AUC0-T calculated as AUC0-T / Dose
+8 more

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort 5, 8 g of KratomExperimental Treatment1 Intervention
A total of 6 subjects will receive an oral single dose administration of the active product
Group II: Cohort 4, 6 g of KratomExperimental Treatment1 Intervention
A total of 6 subjects will receive an oral single dose administration of the active product
Group III: Cohort 3, 4 g of KratomExperimental Treatment1 Intervention
A total of 6 subjects will receive an oral single dose administration of the active product
Group IV: Cohort 2, 2 g of KratomExperimental Treatment1 Intervention
A total of 6 subjects will receive an oral single dose administration of the active product
Group V: Cohort 1, 1 g of KratomExperimental Treatment1 Intervention
A total of 6 subjects will receive an oral single dose administration of the active product
Group VI: PlaceboPlacebo Group1 Intervention
A total of 2 subjects per cohort will receive an oral single dose administration of placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Kratom
2023
Completed Phase 1
~60

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Altasciences Company Inc.Lead Sponsor
11 Previous Clinical Trials
407 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the qualifying criteria for participating in this research endeavor?

"A pre-requisite to join this clinical trial is that the patient must be safe and between 18 and 59 years old. There are 40 spots remaining for potential participants."

Answered by AI

Does this medical study accept participants older than 45?

"This trial is open to individuals aged 18-59 years old. There are additionally 7 trials for minors and 40 clinical studies enrolling seniors over 65."

Answered by AI

Is enrollment open for the experiment at this time?

"Clinicaltrials.gov confirms that enrolment is open for this medical research, which was initially posted on September 12th 2023 and last updated October 2nd of the same year."

Answered by AI

How many test subjects have been enrolled in the current trial?

"Affirmative. According to the information publicly available on clinicaltrials.gov, this medical study is currently enrolling patients and requires 40 participants from one site. The trial was first posted on September 12th 2023 and was most recently updated 2 October of the same year."

Answered by AI

To what extent might 1 g of Kratom be hazardous to patients in Cohort 1?

"Our experts at Power assign Cohort 1, which is comprised of 1g doses of Kratom, a score of one because this is an early-phase trial with limited evidence to support its safety and efficacy."

Answered by AI

Who else is applying?

What site did they apply to?
Altasciences Clinical Kansas, Inc.
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Single Ascending Doses of Kratom in Healthy Nondependent Adults With Opioid Experience
2023. "Single Ascending Doses of Kratom in Healthy Nondependent Adults With Opioid Experience". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06072170.
All > Kansas City
~25 spots leftby Apr 2025
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