Christopher D. Verrico
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.
Inclusion Criteria: 1. English-speaking, 18- to 55-year-old males or females. 2. 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 rat…
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.
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