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Evaluating Kratom and Opioid Effects in People With Past Opioid Use

This study aims to understand how kratom affects people who have previously used opioids. Researchers will compare different doses of kratom (8g, 12g, 16g) with oxycodone HCl and a placebo (an inactive substance). The study will look at how these substances move through your body (pharmacokinetics) and how they make you feel (pharmacodynamics). The main goal is to see how much participants like the drug, measured over eight weeks. You may be able to join if you are between 18 and 55 years old, speak English, and meet other health criteria. The study plans to enroll 72 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 72 participants. It compares different doses of kratom to oxycodone HCl and a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your drug liking will be measured from Treatment Week 1 to Treatment Week 8.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07218549

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

Not Yet Recruiting
PHASE1Ages 18–55Interventional
Christopher D. Verrico
~72 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:PlaceboOxycodone HClKratom 8gKratom 12gKratom 16gKratom 4g

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Drug Liking Visual Analog Scale
Measured over From Treatment Week 1 to Treatment Week 8

Conditions

Opioid Use
Substance Use Disorders
Opioid Analgesia

Explore related trials

Opioid Use DisorderSubstance use disorder

Where it's being run

1 sites across 1 states
Texas1

Study leadership

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

Who to contact

Christopher D Verrico, PhD Pharmacology
[email protected]
713-791-1414 · ext. 226020
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Is a woman of non-childbearing potential defined as no menses for at least 12 months with status confirmed by FSH and estradiol levels at screening or surgically sterile at screening visit OR
Is a woman of childbearing potential and using a contraceptive method that is highly effective, with a failure rate of \<1%, from Screening until 9 months after receiving the study medication. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the dose of study intervention. 3. Male subjects must agree to the following from Day 1 until 9 months after receiving the study medication:
Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
Use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.
Use a male condom when engaging in any activity that allows for passage of ejaculate to another person 4. 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. 5. No current or past diagnosis of severe mental illness, as determined by a clinical interview. 6. 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. 7. 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. 8. Able and willing to give signed informed consent, reliable, and willing to make themselves available for the study's duration and follow study procedures. 9. Agree not to consume any recreational drugs during the study (THC is excluded). 10. Able to perform study procedures as determined by clinical judgment. 11. Able to meet eligibility requirements of the Qualification Phase (i.e., drug discrimination) and Naloxone Challenges.

What this trial measures

  • Drug Liking Visual Analog ScaleFrom Treatment Week 1 to Treatment Week 8

    The primary endpoint of this study will be maximum (peak) effect (Emax) over 24 hours for Drug Liking ("at this moment"), assessed on a bipolar (0 to 100 points) visual analog scale (VAS).