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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
72
Placebo: A single dose of placebo to match kratom (over-encapsulated placebo in 32 opaque 00 capsules) will be administered orally.
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: A single 8 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.
Kratom: A single 12 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.
Kratom: A single 16 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.
Kratom: A single 4 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.
Michael E DeBakey VA Medical Center
Houston, Texas, United States
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 8
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 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.
Time frame: From Treatment Week 1 to Treatment Week 8
Pharmacokinetic (PK)- maximum observed concentration (Cmax)
Pharmacokinetic parameters of kratom alkaloids include maximum observed concentration (Cmax).
Time frame: 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.
Time frame: 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).
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)
Pharmacokinetic parameters of kratom alkaloids include the area under the curve from time 0 to the last measurable observed concentration (AUC0-T).
Time frame: Treatment Week 1 to Treatment Week 8
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.