NCT06089980

Observing the Acute Effects Following a Single Oral Dose of Kratom and Effects Following Kratom Cessation Among Adults Who Use Regularly.

Recruiting now Last updated 22 January 2026

What this trial tests

trial testing Effects from acute kratom exposure in Kratom Pharmacokinetics in 22 participants. Currently enrolling.

Timeline

1 April 2024

Primary endpoint
1 February 2028

1 February 2028

Quick facts

Lead sponsor	Johns Hopkins University
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	22
Start date	1 April 2024
Primary completion	1 February 2028
Estimated completion	1 February 2028
Sites	1 location across United States

Drugs / interventions tested

• Effects from acute kratom exposure

Conditions studied

• Kratom Pharmacokinetics — all drugs for Kratom Pharmacokinetics →
• Kratom Pharmacodynamics — all drugs for Kratom Pharmacodynamics →
• Kratom — all drugs for Kratom →

Sponsor

Johns Hopkins University

Who can join

21 and older, any sex, with Kratom Pharmacokinetics or Kratom Pharmacodynamics. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Peak subjective opioid withdrawal score
  Time frame: Up to 3 days
  Peak score on the Subjective Opioid Withdrawal Scale (SOWS); that occurs between Study Days 1-3. Score range 0-64. 5-point scale of intensity: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. Higher score indicates higher intensity. SOWS will be administered at 8 time points on Study Days 1-2 and 7 time points on Study Day 3.
• Time in minutes until a Subjective Opioid Withdrawal (SOWS) score of more than 11 is reached
  Time frame: up to 3 days
  Time, in minutes, until at least a moderate score (of 11 or higher) is reached on the Subjective Opioid Withdrawal Scale (SOWS). SOWS will be administered at 8 time points on Study Days 1-2 and 7 time points on Study Day 3. 5-point scale of intensity: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. Score range 0-64. Higher score indicates higher intensity.
• Peak rating and changes in rating on Drug Effects Questionnaire (primary subjective outcome)
  Time frame: Up to 3 days
  Drug Effects Questionnaire (DEQ) visual analogue scale (0-100) rating for DEQ item "feeling high." The DEQ will be administered at 7 timepoints on Study Day 1 and at 6 times points on Study Days 2 and 3.
• Peak rating and change in rating on Drug Effects Questionnaire (primary subjective outcome)
  Time frame: Up to 3 days
  Drug Effects Questionnaire (DEQ) visual analogue scale (0-100) rating for DEQ item "drug liking." The DEQ will be administered at 7 time points on Study Day 1 and at 6 times points on Study Days 2 and 3.
• Changes in accuracy on psychomotor task (primary cognitive outcome)
  Time frame: Up to 3 days
  The 2-minute computerized Digit Symbol Substitution Task (DSST) outcome of total number of correct responses (accuracy) within the 2-minute test window. This will evaluate cognitive performance and impairment. The DSST will be administered at 7 time points on Study Day 1 and at 6 times points on Study Days 2 and 3.
• Pupil diameter nadir size as measured in millimeters (mm) (primary physiological outcome).
  Time frame: Up to 3 days
  Pupil diameter in mm under stable light conditions using a pupilometer. Pupil size will be measured at 8 timepoints on Study Days 1 and 2 and at 7 timepoints on Study Day 3

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.