Direct Observation Study of Kratom Product Effects Among Regular Consumers

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06089980
Status
Recruiting
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Conditions

  • Kratom
  • Kratom Pharmacodynamics
  • Kratom Pharmacokinetics

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Effects from acute kratom exposure — BEHAVIORAL
    Participants who regularly use commercial Kratom products will orally consume a known quantity of kratom under direct observation on first study day; following this, participants will stop kratom use for approximately 2 nights and 2.5 days for the duration of the study.

Study Details

The goal of this observational clinical study is to is to learn more about how commercial kratom products affect healthy adults who consume them regularly. The main questions it aims to answer are: 1. What are the acute physiological, subjective, and cognitive effects of kratom following participant self-administration of a single oral dose of the participants usual kratom product at the participants typical dose? 2. What are the physiological, subjective, and cognitive effects associated with kratom product discontinuation among adults who use regularly? 3. What are the pharmacokinetics of kratom products consumed by adults who use regularly? On the first study day: Under direct observation, participants will self-administer a single oral dose of the participants own commercial kratom product that that is regularly taken and will consume it at the participants self-selected typical dose/serving. Following this, serial blood draws and urine collection will occur along with administration of validated questionnaires, tests, and continual monitoring. After this first study day, participants will no longer be permitted to use any of the participants kratom product during the study. On study nights/days 2-3: participants will reside a clinical research unit and be observed and evaluated for kratom withdrawal syndrome.

Key Dates

Start date
Apr 1, 2024
Status verified
Jan 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
22 participants (estimated)

Arms

  • Arm: Acute kratom exposure
    Participants who regularly consume kratom will orally self-administer a single serving of the participants commercial kratom product under direct observation in order to evaluate acute physiological, subjective, and cognitive effects and determine pharmacokinetics. This will occur during the first 24 hours of study participation. Participants will undergo direct observation and assessment for after ceasing all kratom product use. Physiological, subjective, and cognitive effects during this supervised withdrawal will be assessed.

Primary Outcome Measure

Peak subjective opioid withdrawal score [ Time Frame: Up to 3 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21224
Kirsten E Smith, Ph.D.
[email protected]
865-418-8177
Naftali Zeilinger, B.A.
[email protected]
(410) 870-9227
Kirsten E Smith, Ph.D. (PRINCIPAL_INVESTIGATOR)

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Johns Hopkins University· Baltimore, MD

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