Evaluation of the Safety and Effects of Psychoactive Substances in People With Past Opioid Use (NCT07218549) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Evaluation of the Safety and Effects of Psychoactive Substances in People With Past Opioid Use
United States72 participantsStarted 2026-05-01
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. English-speaking, 18- to 55-year-old males or females.
. Female subjects must have a negative serum pregnancy test at time of screening and negative urine pregnancy test upon admission. In addition, female subjects must meet one of the following conditions:
. Male subjects must agree to the following from Day 1 until 9 months after receiving the study medication:
. Physically healthy, as determined by a clinical interview with a physician, laboratory tests (urinalysis, blood chemistry, 12-lead ECG), physical examination, and self-reported medical history.
. No current or past diagnosis of severe mental illness, as determined by a clinical interview.
. Clinical laboratory test results (CMP, CBC, etc.) must be within the normal reference range or with acceptable deviations that are judged to be not clinically significant by a study physician.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Drug Liking Visual Analog Scale
Timeframe: From Treatment Week 1 to Treatment Week 8
. Have a history of self-reported recreational opioid use as defined by at least 10 times in the past year and at least once in the 12 weeks before screening.
. Able and willing to give signed informed consent, reliable, and willing to make themselves available for the study's duration and follow study procedures.
Exclusion criteria
. Seeking treatment for a substance or alcohol use disorder as determined by self-report during the intake interview.
. Current or past diagnosis of opioid use disorder or other substance use disorder (SUD) within the past year, excluding THC and nicotine-containing products. With regard to marijuana/THC, an individual must be able to tolerate 48 hours of abstinence from marijuana/THC products.
. History of opioid overdose.
. Using medication or supplements that might interact with kratom or oxycodone as determined by self-report during intake interview.
. Treatment with any investigational drug during the last 30 days.
. Participants on parole or probation.
. Currently pregnant or trying to conceive or currently lactating as determined by blood pregnancy testing at screening, urine pregnancy testing at admission, and self-reporting during interview and study visits.
. Current or recent history of significant violent or suicidal behavior or suicidal/homicidal risk as determined by the C-SSRS.