Assessing the Pharmacokinetics and Drug Interaction Liability of Kratom, an Opioid-like Natural Product

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

October 9, 2019

Primary Completion Date

August 31, 2021

Study Completion Date

August 31, 2021

Conditions
Interaction Drug Food
Interventions
DRUG

Midazolam HCl

Oral syrup, 2 mg/mL

DRUG

Dextromethorphan HBr

Oral liquid capsules, 15 mg

DIETARY_SUPPLEMENT

Kratom

Kratom (Moon Kratom Yellow Indonesian, lot 51) is supplied as a dry leaf powder in clear plastic bags, each weighing 5 kg. Two g of kratom dry leaf powder will be stirred into 240 mL of hot water to make a tea. The tea will be cooled to 50 degrees Celsius before administration. Subjects will drink the tea within 10 minutes of administration.

Trial Locations (1)

99202

Washington State University College of Pharmacy and Pharmaceutical Sciences, Spokane

All Listed Sponsors
collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

lead

Washington State University

OTHER

NCT04392011 - Assessing the Pharmacokinetics and Drug Interaction Liability of Kratom, an Opioid-like Natural Product | Biotech Hunter | Biotech Hunter