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

NCT07218549 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: H-56391
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Substance Use Disorders; Opioid Analgesia; Opioid Use

Keywords

Opioid Use; Substance Use Disorders

Outcome Measures

Primary Outcomes (1)

• Drug Liking Visual Analog Scale

  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).

  From Treatment Week 1 to Treatment Week 8

Secondary Outcomes (6)

• Overall Drug Liking Visual Analog Scale

  From Treatment Week 1 to Treatment Week 8

• Take Drug Again Visual Analog Scale

  From Treatment Week 1 to Treatment Week 8

• Pharmacokinetic (PK)- maximum observed concentration (Cmax)

  Treatment Week 1 to Treatment Week 8

• Safety- Adverse Events

  Treatment Week 1 to Treatment Week 8

• Pharmacokinetic (PK)- time of last measurable observed concentration (Tlast)

  Treatment Week 1 to Treatment Week 8

Study Arms (6)

Treatment Sequence A

PLACEBO COMPARATOR

Placebo: A single dose of placebo to match kratom (over-encapsulated placebo in 32 opaque 00 capsules) will be administered orally.

Drug: Placebo

Treatment Sequence B

ACTIVE COMPARATOR

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: Oxycodone HCl

Treatment Sequence C

ACTIVE COMPARATOR

Kratom: A single 4 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.

Drug: Kratom 4g

Treatment Sequence D

EXPERIMENTAL

Kratom: A single 8 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.

Drug: Kratom 8g

Treatment Sequence E

EXPERIMENTAL

Kratom: A single 12 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.

Drug: Kratom 12g

Treatment Sequence F

EXPERIMENTAL

Kratom: A single 16 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.

Drug: Kratom 16g

Interventions

Placebo DRUG

Placebo: A single dose of placebo to match kratom (over-encapsulated placebo in 32 opaque 00 capsules) will be administered orally.

Treatment Sequence A

Oxycodone HCl DRUG

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.

Treatment Sequence B

Kratom 8g DRUG

Kratom: A single 8 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.

Treatment Sequence D

Kratom 12g DRUG

Kratom: A single 12 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.

Treatment Sequence E

Kratom 16g DRUG

Kratom: A single 16 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.

Treatment Sequence F

Kratom 4g DRUG

Kratom: A single 4 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.

Treatment Sequence C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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.
• Male subjects must agree to the following from Day 1 until 9 months after receiving the study medication:
• Not donate fresh unwashed semen
• Plus, either:
• 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
• 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.
• 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.

You may not qualify if:

• 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.
• Sensitivity, allergy, or contraindications/allergies to kratom, opioids, or similar compounds.
• Use prescription or nonprescription drugs and dietary supplements within seven days or five half-lives (whichever is longer) that, in the opinion of the study clinician may interfere with the investigational product.
• Positive urine drug screen (UDS) for substances of abuse at each admission in the Qualification and Treatment phases, excluding tetrahydrocannabinol (THC). If a participant presents with a positive UDS excluding THC at any admission or any visit, the investigator, at their discretion, may reschedule a repeat of UDS until the UDS is negative, excluding THC, before the participant is permitted to participate in any phase of the study.
• Positive alcohol breathalyzer test at each admission in the Qualification and Treatment Phase.
• History of sensitivity to heparin or heparin-induced thrombocytopenia.
• Has not donated blood or plasma within the last six weeks.
• Has a history of increased intracranial pressure or brain tumors.

Sponsors & Collaborators

• Christopher D. Verrico: lead
• Baylor College of Medicine: collaborator

Study Sites (1)

Michael E DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Christopher D Verrico, PhD Pharmacology

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher D Verrico, PhD Pharmacology

CONTACT

713-791-1414; verrico@bcm.edu

Adetola Vaughan, MA Psychology

CONTACT

713-791-1414; avaughan@bcm.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 6-way crossover study to determine the abuse potential of kratom relative to oxycodone and placebo.

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: October 20, 2025
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): May 31, 2029
• Last Updated: March 13, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)