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

Summary

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

Age range

18–55 years

Sex

All

Healthy volunteers

Yes

Interventions

• Drug
  Placebo

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

• Drug
  Oxycodone HCl

  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.

• Drug
  Kratom 8g

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

• Drug
  Kratom 12g

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

• Drug
  Kratom 16g

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

• Drug
  Kratom 4g

  Kratom: A single 4 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.

Location