Opioid UsePhase 1NCT07218549
Evaluation of the Safety and Effects of Psychoactive Substances in People With Past Opioid Use
A Phase 1 study testing Oxycodone HCl, Kratom 8g and Kratom 12g in people with Opioid Use and Substance Use Disorders, run by Christopher D. Verrico at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use, Substance Use Disorders, Opioid Analgesia
- What is being tested?
- Oxycodone HCl, Kratom 8g and Kratom 12g
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 31 May 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 90 days after receiving the study medication:
- Not donate fresh unwashed semen
Show all 19Show fewer
- 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.
- 5. No current or past diagnosis of severe mental illness, as determined by the Mini-International Neuropsychiatric Interview (M.I.N.I.) demonstrating no clinically significant contraindications for study participation, in the judgment of a Study Physician.
- 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.
- Have a history of self-reported recreational stimulant use sufficient to be familiar with the subjective effects of stimulant-class drugs, as determined by the investigator. Recreational stimulant use may include cocaine, amphetamine, methamphetamine, or nonmedical use of prescription stimulants.
- Able and willing to give signed informed consent, reliable, and willing to make themselves available for the study's duration and follow study procedures.
- Agree not to consume any recreational drugs during the study.
- Able to perform study procedures as determined by clinical judgment.
- Able to meet eligibility requirements of the Qualification Phase (i.e., drug discrimination) and Naloxone Challenges.
Who cannot join
- 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 nicotine-containing products. Prior marijuana/THC use is permitted provided, in the opinion of the investigator, the participant is able and willing to comply with the protocol-required abstinence from marijuana/THC products for the study duration.
- 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.
Show all 21Show fewer
- Currently pregnant or trying to conceive or currently lactating as determined by serum 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 14 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, except that a THC-positive UDS alone will not automatically exclude a participant or preclude dosing. Because urinary THC metabolites may remain detectable for prolonged periods after prior use and are not a reliable indicator of acute intoxication or pharmacologically relevant recent exposure, THC eligibility will be determined based on self-reported recent use, clinical assessment, and investigator judgment. Participants who report marijuana/THC use prior to admission, appear under the acute influence of THC, or are otherwise judged by study staff to have recent intoxication will not be dosed and may be rescheduled or withdrawn, as appropriate.
- Positive alcohol breathalyzer test at each admission in the Qualification and Treatment Phase.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Has donated blood or plasma within the last six weeks.
- Has a history of increased intracranial pressure or brain tumors.
- Has gastrointestinal obstruction, including paralytic ileus.
- Has a history of seizure disorders.
- Has chronic obstructive pulmonary disease or cor pulmonale.
- Has a history of anemia or any other significant hematologic disorder.
- Has a condition or abnormality that, in the opinion of the PI or Study Physician, would compromise the safety of the patient or the quality of the data.
- Has a major surgery planned within 6 months of screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Michael E DeBakey VA Medical Center
Houston, Texas, 77030
Christopher D Verrico, PhD Pharmacology, 713-791-1414 ext. 226020, verrico@bcm.edu
Adetola Vaughan, MA Psychology, 713-798-7658, avaughan@bcm.edu
About this study
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
- Opioid Use, Substance Use Disorders, Opioid Analgesia
- Being tested
- Placebo, Oxycodone HCl, Kratom 8g, Kratom 12g, Kratom 16g
- Keywords
- Opioid Use, Substance Use Disorders
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo: A single dose of placebo to match kratom (over-encapsulated placebo in 32 opaque 00 capsules) will be administered orally.
Oxycodone HClDrug
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.
Kratom 8gDrug
Kratom: A single 8 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.
Kratom 12gDrug
Kratom: A single 12 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.
Kratom 16gDrug
Kratom: A single 16 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.
Kratom 4gDrug
Kratom: A single 4 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Kratom 4g |
| Treatment Sequence D | Experimental | Kratom: A single 8 g dose of kratom (in 32 opaque 00 capsules) will be administered orally. Receives: Drug: Kratom 8g |
| Treatment Sequence E | Experimental | Kratom: A single 12 g dose of kratom (in 32 opaque 00 capsules) will be administered orally. Receives: Drug: Kratom 12g |
| Treatment Sequence F | Experimental | Kratom: A single 16 g dose of kratom (in 32 opaque 00 capsules) will be administered orally. Receives: Drug: Kratom 16g |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From Treatment Week 1 to Treatment Week 8
Secondary outcomes (6)
Overall Drug Liking Visual Analog Scale
Overall drug liking of the study products will be assessed 12 and 24 hours following each dose in the Treatment phase. VAS assessments will be scored on a 100-point scale, where a rating of "0" reflects the complete absence of a subjective effect while a rating of "100" reflects the maximum presence of a subjective effect.
Measured: From Treatment Week 1 to Treatment Week 8
Take Drug Again Visual Analog Scale
Take Drug Again will be assessed 12 and 24 hours following each dose in the Treatment phase. VAS assessments will be scored on a 100-point scale, where a rating of "0" reflects the complete absence of a subjective effect while a rating of "100" reflects the maximum presence of a subjective effect.
Measured: From Treatment Week 1 to Treatment Week 8
Pharmacokinetic (PK)- maximum observed concentration (Cmax)
Pharmacokinetic parameters of kratom alkaloids include maximum observed concentration (Cmax).
Measured: Treatment Week 1 to Treatment Week 8
Safety- Adverse Events
Endpoints will include a summary of the incidence of adverse events (AEs), serious adverse events (SAEs), as well as descriptive summary and statistics of the safety parameters.
Measured: Treatment Week 1 to Treatment Week 8
Pharmacokinetic (PK)- time of last measurable observed concentration (Tlast)
Pharmacokinetic parameters of kratom alkaloids include time of last measurable observed concentration (Tlast).
Measured: Treatment Week 1 to Treatment Week 8
Pharmacokinetic (PK)- area under the curve from time 0 to the last measurable observed concentration (AUC0-T)
Pharmacokinetic parameters of kratom alkaloids include the area under the curve from time 0 to the last measurable observed concentration (AUC0-T).
Measured: Treatment Week 1 to Treatment Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start1 Sep 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 6-way crossover study to determine the abuse potential of kratom relative to oxycodone and placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christopher D. Verrico
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine
- Responsible party
- Sponsor-investigator, Christopher D. Verrico, Baylor College of Medicine
- Investigators
- Christopher D Verrico, PhD Pharmacology, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218549
- Sponsor's protocol ID
- H-56391
- Other IDs
- 5U01FD008327-02
- Status last verified
- Oct 2026
- First submitted
- 18 Sep 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Effects of Psychoactive Substances in People With Past Opioid Use
- ClinicalTrials.gov ID
- NCT07218549
- Acronym / sponsor ID
- H-56391
- Conditions
- Opioid Use, Substance Use Disorders, Opioid Analgesia
- Keywords
- Opioid Use, Substance Use Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Christopher D. VerricoUniversity, hospital or other
- Collaborators
- Baylor College of Medicine
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 20 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
- Model description
- 6-way crossover study to determine the abuse potential of kratom relative to oxycodone and placebo.
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence A | Placebo comparator | Drug: PlaceboPlacebo: A single dose of placebo to match kratom (over-encapsulated placebo in 32 opaque 00 capsules) will be administered orally. |
| Treatment Sequence B | Active comparator | Drug: Oxycodone HClActive 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 C | Active comparator | Drug: Kratom 4gKratom: A single 4 g dose of kratom (in 32 opaque 00 capsules) will be administered orally. |
| Treatment Sequence D | Experimental | Drug: Kratom 8gKratom: A single 8 g dose of kratom (in 32 opaque 00 capsules) will be administered orally. |
| Treatment Sequence E | Experimental | Drug: Kratom 12gKratom: A single 12 g dose of kratom (in 32 opaque 00 capsules) will be administered orally. |
| Treatment Sequence F | Experimental | Drug: Kratom 16gKratom: A single 16 g dose of kratom (in 32 opaque 00 capsules) will be administered orally. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- 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 90 days 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.
- 5. No current or past diagnosis of severe mental illness, as determined by the Mini-International Neuropsychiatric Interview (M.I.N.I.) demonstrating no clinically significant contraindications for study participation, in the judgment of a Study Physician.
Key exclusion criteria (21 listed)
- 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 nicotine-containing products. Prior marijuana/THC use is permitted provided, in the opinion of the investigator, the participant is able and willing to comply with the protocol-required abstinence from marijuana/THC products for the study duration.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo: A single dose of placebo to match kratom (over-encapsulated placebo in 32 opaque 00 capsules) will be administered orally. | Drug | Treatment Sequence A |
| Oxycodone HClActive 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 | Treatment Sequence B |
| Kratom 8gKratom: A single 8 g dose of kratom (in 32 opaque 00 capsules) will be administered orally. | Drug | Treatment Sequence D |
| Kratom 12gKratom: A single 12 g dose of kratom (in 32 opaque 00 capsules) will be administered orally. | Drug | Treatment Sequence E |
| Kratom 16gKratom: A single 16 g dose of kratom (in 32 opaque 00 capsules) will be administered orally. | Drug | Treatment Sequence F |
| Kratom 4gKratom: A single 4 g dose of kratom (in 32 opaque 00 capsules) will be administered orally. | Drug | Treatment Sequence C |
Primary outcome
Drug Liking Visual Analog Scale
Time frame: From 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).
6 secondary outcomes
Overall Drug Liking Visual Analog Scale
Time frame: From Treatment Week 1 to Treatment Week 8
Take Drug Again Visual Analog Scale
Time frame: From Treatment Week 1 to Treatment Week 8
Pharmacokinetic (PK)- maximum observed concentration (Cmax)
Time frame: Treatment Week 1 to Treatment Week 8
Safety- Adverse Events
Time frame: Treatment Week 1 to Treatment Week 8
Pharmacokinetic (PK)- time of last measurable observed concentration (Tlast)
Time frame: Treatment Week 1 to Treatment Week 8
Pharmacokinetic (PK)- area under the curve from time 0 to the last measurable observed concentration (AUC0-T)
Time frame: Treatment Week 1 to Treatment Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Opioid Use
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher D Verrico, PhD Pharmacology principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxycodone HCl, Kratom 8g and Kratom 12g in people with Opioid Use and Substance Use Disorders, run by Christopher D. Verrico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher D Verrico, PhD Pharmacology (713-791-1414 ext. 226020, verrico@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug Liking Visual Analog Scale (time frame: From Treatment Week 1 to Treatment Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.