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

NCT06072170 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-09-29

Study results available
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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

Interventions

DRUG

Kratom

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Altasciences Company Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-16
Primary Completion
2024-01-23
Completion
2024-01-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06072170 on ClinicalTrials.gov