Preliminary Characterization of Commercial Kratom Extract Products

Conditions

• Kratom Pharmacodynamics
• Kratom Pharmacokinetics

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Accepted

Study Details

To understand the acute subjective, physiological, and cognitive effects of commercial kratom extract products among US adults who consume these products regularly, and to understand how these products are metabolized by the human body.

Key Dates

Start date

Nov 11, 2024

Status verified

Nov 2025

Primary completion

Nov 11, 2027

Completion

Nov 1, 2028

Study Design

Enrollment

16 participants (estimated)

Arms

• Arm: US Adult Kratom Extract Consumers
  Participants who regularly consume commercial kratom extracts will orally self-administer a single serving of their commercial kratom extract product under direct observation in order to evaluate acute physiological, subjective, and cognitive effects and determine pharmacokinetics. Participants will undergo direct observation and assessment for acute self-administration and for a period following the peak effects (i.e., a period of short abstinence). Physiological, subjective, and cognitive effects will be measured in an inpatient unit where the participant will reside for 2 days and 1 night (consecutive).

Primary Outcome Measure

Drug Effects Questionnaire [ Time Frame: Administered at 7 timepoints on Study Days 1-2 ]

Central Contacts

• Kirsten E Smith, MSW, PhD
  865-418-8177
  [email protected]
• Carlos Austin Zamarripa, PhD
  410-550-6969
  [email protected]

Locations (2)

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