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NCT06072170 · ClinicalTrials.gov registry record · Phase 1
Single Ascending Doses of Kratom in Healthy Nondependent Adults With Opioid Experience
A Phase 1 study of Pharmacokinetics and Safety, sponsored by Altasciences Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06072170: Completed Phase 1 study of Pharmacokinetics and Safety, sponsored by Altasciences Company.
NCT06072170 is a Phase 1 study of Pharmacokinetics and Safety that has completed, run by Altasciences Company. The registered enrollment target is 40 participants, below the 61-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (34% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06072170, a Phase 1 study of Pharmacokinetics and Safety, has completed, sponsored by Altasciences Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Kratom
Study Locations (1)
Kansas
- Altasciences Clinical Kansas, Inc. - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-08-16 |
| Est. Completion | 2024-01-23 |
| Phase | Phase 1 |
What the finished NCT06072170 record still lists
NCT06072170 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 61-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (34% lower).
The record links to 3 conditions, with Pharmacokinetics appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06072170 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT06072170 about?
NCT06072170 is a clinical study titled "Single Ascending Doses of Kratom in Healthy Nondependent Adults 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...
What is the current status of trial NCT06072170?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2023-08-16. Estimated completion is 2024-01-23.
What conditions does trial NCT06072170 study?
This clinical trial studies the following conditions: Pharmacokinetics, Safety, Pharmacodynamics.
What interventions are being tested in trial NCT06072170?
The interventions under investigation include: Placebo (DRUG), Kratom (DRUG).
Who is sponsoring clinical trial NCT06072170?
This trial is sponsored by Altasciences Company, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06072170 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06072170's enrollment target sits among peer trials
40 9th of 37 higher than 26 of 37 other Pharmacokinetics trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pharmacokinetics trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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