CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 40 enrolled
Drug / intervention
Kratom +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06072170
NCT06072170Phase 1Completed
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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

Altasciences Company Inc.·interventional·Posted Oct 10, 2023·Updated Sep 29, 2025

In Brief

A Phase 1 clinical trial evaluating Kratom and Placebo for Safety and 2 related conditions. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSafety, Pharmacokinetics, Pharmacodynamics
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
202420252026
First PostedOct 10, 2023
Enrollment StartAug 16, 2023
Primary CompletionJan 23, 2024
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 2.7 years ago

Interventions

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