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Arm 2 for Drug-Food Interaction

Phase < 1
Waitlist Available
Research Sponsored by Washington State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, 24, 48, 72, 96,120, and 144 hours
Awards & highlights

Study Summary

This trial will study the effects of a well-characterized kratom product on two drug metabolizing enzymes, CYP2D6 and CYP3A4. The trial will use healthy volunteers and the probe drugs dextromethorphan and midazolam. Results from this trial will provide useful information regarding risks associated with co-consuming kratom with opioids and other CYP2D6 and CYP3A4 drug substrates.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, 24, 48, 72, 96,120, and 144 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, 24, 48, 72, 96,120, and 144 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Midazolam Area Under the Concentration vs. Time Curve (AUC)
Secondary outcome measures
Dextromethorphan Area Under the Concentration vs. Time Curve (AUC)
Midazolam and Dextromethorphan Cmax
Midazolam and Dextromethorphan Half-life
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment3 Interventions
Arm 2 is divided into Arms 2a and 2b. Twelve non-naive subjects (6 males, 6 females) will participate in Arm 2a. Subjects who participate in this study arm will be administered an oral probe drug cocktail of dextromethorphan HBr (2 x 15 mg liquid capsules; 30 mg total) and midazolam HCl (1.25 mL of 2 mg/mL syrup; 2.5 mg total). Plasma will be collected from 0-24 hours. Urine will be collected from 0-24 hours. A washout period of 7 days will separate Arms 2a and 2b. For Arm 2b, the same 12 subjects will be administered a combination of a well-characterized kratom product (2 g) by mouth as a tea with an oral probe drug cocktail consisting of dextromethorphan HBr (2, 15 mg liquid capsules; 30 mg total) and midazolam HCl (1.25 mL of 2 mg/mL syrup; 2.5 mg total). Plasma will be collected from 0-12 hours and during a midpoint collection within 5 days of the 24-hour blood collection. Urine will be collected from 0-24 hours.
Group II: Arm 1Experimental Treatment1 Intervention
Six non-naive* subjects (3 males, 3 females) will be administered a single low dose of a well-characterized kratom product (2 g) by mouth as a tea. These subjects may or may not choose to participate in Arms 2a and 2b. For subjects who will participate in Arms 2a and 2b, a washout period of 7 days will separate Arm 1 and Arm 2. Plasma will be collected from 0-120 hours and during the washout period. Urine will be collected from 0-120 hours. *Non-naive subjects are defined as intermittent users who consume 2-8 g kratom at least once per month but no more than three times daily within the last six months prior to screening and are willing to abstain for several weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dextromethorphan HBr
2019
Completed Phase 1
~30
Kratom
2023
Completed Phase 1
~60
Midazolam HCl
2019
Completed Early Phase 1
~20

Find a Location

Who is running the clinical trial?

National Center for Complementary and Integrative Health (NCCIH)NIH
831 Previous Clinical Trials
668,918 Total Patients Enrolled
Washington State UniversityLead Sponsor
101 Previous Clinical Trials
56,699 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Assessing the Pharmacokinetics and Drug Interaction Liability of Kratom, an Opioid-like Natural Product
Mary Paine 2019. "Assessing the Pharmacokinetics and Drug Interaction Liability of Kratom, an Opioid-like Natural Product". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04392011.
~3 spots leftby Apr 2025
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