Health Trials

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

ConditionsOpioid UseSubstance Use DisordersOpioid Analgesia
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorChristopher D. Verrico

About this trial

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.

Eligibility criteria

Qualifiers

English-speaking, 18- to 55-year-old males or females.

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.

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Placebo
  • Oxycodone HCl
  • Kratom 8g
  • Kratom 12g
  • Kratom 16g
  • Kratom 4g

Treatment groups

72 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Locations

1
Michael E DeBakey VA Medical Center77030, HoustonTexas, United States

Sponsors and collaborators

Christopher D. Verrico

Lead sponsor

Baylor College of Medicine

Sponsor institution

Baylor College of Medicine

Collaborator

Source ClinicalTrials.gov