NCT06072170

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Altasciences Company Inc. · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-08-16
• Primary completion: 2024-01-23
• Completion: 2024-01-23
• First posted: 2023-10-10
• Last updated: 2025-09-29
• Results posted: 2025-09-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study