MedTrace Logo

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

NCT07218549 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-03-13

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Baylor College of Medicine

    collaborator OTHER

  • Christopher D. Verrico

    lead OTHER

Principal Investigators

  • Christopher D Verrico, PhD Pharmacology · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2028-12-31
Completion
2029-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT07218549 on ClinicalTrials.gov