NCT07218549

Evaluation of the Safety and Effects of Psychoactive Substances in People With Past Opioid Use

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Christopher D. Verrico · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to understand how kratom affects people. In this study, kratom will be compared with another substance and a placebo (an inactive substance). Researchers will also study how the substances move through and affect the body. This includes examining how the body absorbs, processes, and eliminates the drug (pharmacokinetics), as well as how the drug affects the body and how it may make you feel (pharmacodynamics). The information collected will help researchers better understand the effects and potential risks of kratom.

Conditions

• Opioid Use
• Substance Use Disorders
• Opioid Analgesia

Interventions

Type	Name	Description
DRUG	Placebo	Placebo: A single dose of placebo to match kratom (over-encapsulated placebo in 32 opaque 00 capsules) will be administered orally.
DRUG	Oxycodone HCl	Active Control: A single 30 mg dose of oxycodone (1 X 30 mg tablet over-encapsulated placebo in 32 opaque 00 capsules) will be administered orally.
DRUG	Kratom 8g	Kratom: A single 8 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.
DRUG	Kratom 12g	Kratom: A single 12 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.
DRUG	Kratom 16g	Kratom: A single 16 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.
DRUG	Kratom 4g	Kratom: A single 4 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-12-31
• Completion: 2029-05-31
• First posted: 2025-10-20
• Last updated: 2026-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study