Evaluation of the Safety and Effects of Psychoactive Substances in People With Past Opioid Use
Trial statusRecruiting
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
This trial accepts healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Placebo
DrugPlacebo: A single dose of placebo to match kratom (over-encapsulated placebo in 32 opaque 00 capsules) will be administered orally.
Oxycodone HCl
DrugActive 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 8g
DrugKratom: A single 8 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.
Kratom 12g
DrugKratom: A single 12 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.
Kratom 16g
DrugKratom: A single 16 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.
Kratom 4g
DrugKratom: A single 4 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.
Treatment groups
72 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Treatment Sequence APlacebo comparator 1 intervention
Group B: Treatment Sequence BActive comparator 1 intervention
Group C: Treatment Sequence CActive comparator 1 intervention
Group D: Treatment Sequence DExperimental treatment 1 intervention
Group E: Treatment Sequence EExperimental treatment 1 intervention
Group F: Treatment Sequence FExperimental treatment 1 intervention
Trial outcomes
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).
Time frame
From Treatment Week 1 to Treatment Week 8Secondary outcomes
1
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.
Time frame
From Treatment Week 1 to Treatment Week 82
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.
Time frame
From Treatment Week 1 to Treatment Week 83
Pharmacokinetic (PK)- maximum observed concentration (Cmax)
Pharmacokinetic parameters of kratom alkaloids include maximum observed concentration (Cmax).
Time frame
Treatment Week 1 to Treatment Week 84
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.
Time frame
Treatment Week 1 to Treatment Week 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Christopher D. Verrico
Lead sponsor
Baylor College of Medicine
Sponsor institution
Baylor College of Medicine
Collaborator
Source ClinicalTrials.gov