Psychoactive Substances for Opioid Use Disorder

Overseen By Adetola Vaughan, MA Psychology

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Christopher D. Verrico

Must not be taking: Kratom, Oxycodone, others

Disqualifiers: Opioid use disorder, Overdose, others

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the safety and tolerability of certain psychoactive substances, such as kratom and oxycodone (a prescription opioid pain medication), in individuals with a history of recreational opioid use. Researchers seek to understand the pharmacokinetics (how these drugs move through the body) and pharmacodynamics (their effects on the body). The trial includes different groups: some receive a placebo, others receive oxycodone, and some try varying doses of kratom. Eligible participants have used opioids recreationally at least 10 times in the past year and are not seeking treatment for substance use disorders. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop using prescription or nonprescription drugs and dietary supplements within seven days or five half-lives (whichever is longer) if they might interfere with the study medication. It's best to discuss your specific medications with the study team to see if they are allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study linked kratom to serious health issues, including liver problems, seizures, and addiction, as noted by the FDA. Some users have reported rare but severe effects, such as mental health and heart problems. Additionally, the FDA has not approved kratom for any medical use, raising safety concerns.

Oxycodone, a prescription painkiller, effectively manages pain but can cause serious problems like addiction and breathing issues, especially if misused. Studies show a higher risk for those unaccustomed to strong pain medicines.

Both treatments in this trial carry potential risks. Considering these safety concerns is important when deciding to join a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using kratom for opioid use disorder because it presents a novel approach compared to traditional opioid treatments like methadone or buprenorphine. Kratom is derived from a plant and contains mitragynine, which acts on opioid receptors but is thought to have a different safety profile, potentially offering relief with lower risk of addiction. Additionally, its herbal origin might appeal to individuals seeking more natural treatment options, offering an alternative for those who struggle with conventional therapies.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

This trial will compare the effects of kratom and oxycodone for opioid use disorder. Research has shown that kratom, which participants in this trial may receive, has effects similar to opioids. Some individuals use it to alleviate withdrawal symptoms when discontinuing opioids like heroin or oxycodone. However, the FDA warns that kratom can pose risks such as liver damage and addiction. Although the risk of a fatal kratom overdose is much lower than with opioids, caution remains essential.

Oxycodone, another treatment option in this trial, effectively treats severe pain, especially when other pain medications fail. However, it can lead to addiction and physical dependence, so careful use under a doctor's supervision is crucial. ^{1 3 6 7 8}

Who Is on the Research Team?

Christopher D Verrico, PhD Pharmacology

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals with a history of opioid use, including heroin or oxycodone. Participants should have used recreational drugs like kratom, morphine, cocaine, fentanyl, PCP, LSD etc. The study excludes certain details which are not provided here.

Inclusion Criteria

No current or past diagnosis of severe mental illness

Clinical laboratory test results within normal reference range or with acceptable deviations

History of self-reported recreational opioid use

Exclusion Criteria

Current or past diagnosis of opioid use disorder or other substance use disorder within the past year, excluding THC and nicotine-containing products

History of opioid overdose

I am taking medications or supplements that may interact with kratom or oxycodone.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive various doses of placebo, oxycodone, or kratom to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics

8 weeks

Weekly visits for 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Kratom
• Oxycodone HCl

Trial Overview The study tests the safety and effects of Kratom at different doses (8g, 12g, 16g), Oxycodone HCl as a known comparison substance and a placebo. It aims to understand how these substances are processed by the body and their impact on participants.

How Is the Trial Designed?

Group I: Treatment Sequence F Experimental Treatment 1 Intervention

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

Group II: Treatment Sequence E Experimental Treatment 1 Intervention

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

Group III: Treatment Sequence D Experimental Treatment 1 Intervention

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

Group IV: Treatment Sequence B Active Control 1 Intervention

Active Control: A single 20 mg dose of oxycodone (1 X 20 mg tablet over-encapsulated placebo in 32 opaque 00 capsules) will be administered orally.

Group V: Treatment Sequence C Active Control 1 Intervention

Active Control: A single 40 mg dose of oxycodone (2 X 20 mg tablets over-encapsulated placebo in 32 opaque 00 capsules) will be administered orally.

Group VI: Treatment Sequence A Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Christopher D. Verrico

Lead Sponsor

Trials

2

Recruited

120+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8319032/

Past-Year Kratom Use in the U.S.: Estimates From a Nationally ... Kratom is a plant with partial opioid agonist effects, and its use has become popular to ameliorate symptoms of opioid withdrawal. Use, however, has been linked ...

2. fda.gov fda.gov/news-events/public-health-focus/fda-and-kratom

FDA and Kratom FDA has warned consumers not to use kratom because of the risk of serious adverse events, including liver toxicity, seizures, and substance use disorder (SUD).

3. mayoclinic.org mayoclinic.org/diseases-conditions/prescription-drug-abuse/in-depth/kratom/art-20402171

Kratom: Unsafe and ineffective In a study testing kratom as a treatment for symptoms of quitting opioids, called withdrawal, people who took kratom for more than six months ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0091743519303275

Risk of death associated with kratom use compared to ... It appears that the risk of overdose death is >1000 times greater for opioids than for kratom. The limitations of the mortality risk estimate warrants caution.

5. hopkinsmedicine.org hopkinsmedicine.org/news/articles/2025/02/emerging-use-of-kratom-in-us-kratom-use-disorder-experts-propose-decision-making-algorithm-for-clinicians

Emerging Use of Kratom in US Johns Hopkins KUD experts lead first empirical study to better understand kratom withdrawal symptoms.

6. nida.nih.gov nida.nih.gov/research-topics/kratom

Kratom | National Institute on Drug Abuse - Nida.nih.gov Rare but serious effects have been reported in people who use kratom, including psychiatric, cardiovascular, gastrointestinal and respiratory ...

7. dshs.texas.gov dshs.texas.gov/news-alerts/serious-illnesses-associated-7-oh-use

Serious Illnesses Associated with 7-OH Use | Texas DSHS Kratom and 7-OH do not have an FDA-approved medical use, and products containing 7-OH have not been proven to be safe or effective. Clinical ...

8. unthsc.edu unthsc.edu/college-of-public-health/public-health-researcher-warns-of-the-drug-kratoms-dangers-and-advocates-for-legislation-governing-this-substance-of-concern/

Public health researcher warns of the drug kratom's ... “The FDA warns consumers not to use kratom products because of the risk of serious adverse effects, including toxicity, seizures and development ...