UNDERSTANDING KRATOM’S EFFECTS AND ABUSE POTENTIAL: DESIGN OF THE FIRST FDA-FUNDED HUMAN STUDY

Kratom is a plant used by millions of people in the United States, often to manage pain, improve mood, or ease opioid withdrawal. However, very little clinical research has tested how kratom affects people, whether it is reinforcing or addictive, or how its effects compare to approved opioids . To help fill this major gap, the U.S. Food and Drug Administration funded our team to conduct the first controlled human study designed to measure kratom’s abuse potential. This phase 1 study will be conducted at the Michael E. DeBakey VA Medical Center in Houston, Texas. Healthy adults who have used opioids recreationally but are not dependent on them will be enrolled. Each participant will complete a qualification process to confirm safety and to ensure they can reliably distinguish drug effects from placebo. Participants will then complete six inpatient study sessions and receive kratom at three to four different doses, oxycodone at one or two doses, and placebo in random order. How much participants subjectively “like” the drug using a bipolar 0-100 VAS scale, whether they would want to take it again, and whether they feel “high ” will be measured. These ratings are standard tools used in FDA-required Human Abuse Potential (HAP) studies . Blood samples will be collected to understand how kratom’s active compounds are absorbed and processed, and participant safety will be monitored through vital signs, ECGs, and lab tests. This study will provide the first clear, controlled data on kratom’s subjective effects, safety profile, and potential for abuse—information that is essential for guiding responsible regulation and future research.