Skip to content
Bored Studies
RecruitingAccepts healthy volunteersPhase 1Mentions an overnight / inpatient stay

The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles

Johns Hopkins University · with National Institute on Drug Abuse (NIDA) · NCT05602649

View Study & Apply (opens in a new tab)

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 21–55 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1
Target enrollment
80
US sites recruiting
1
Study start
July 10, 2024
Record last updated
April 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

This study will examine the pharmacokinetics and pharmacodynamics of delta-9-tetrahydrocannabinol (THC)-infused chocolates, gummies, and drinks. Healthy adults (N=40) will complete 9 drug administration sessions, including an overnight stay prior to each session. Participants will consume THC containing products in a fasted state; following drug administration, the participants will complete cognitive and psychomotor tasks, subjective assessments, have blood collected, and vital signs monitored.

Being studied: Cannabis; Placebo

Conditions: Cannabis Use

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Have provided written informed consent.
  • Be between the ages of 21 and 55.
  • Be in good general health based on screening procedures (e.g., physical exam, medical history interview, vital signs, routine blood tests).
  • Test negative for illicit drugs (including cannabis) and test negative for alcohol (0% BAC) at screening and before any study sessions.
  • Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at admission for each session.
  • Have prior experience using THC-dominant cannabis.
  • Have a body mass index (BMI) in the range of 16 to 38 kg/m2.
  • Have not donated blood in the past 30 days.

Exclusion Criteria

  • Self-reported use of illicit drugs (e.g., amphetamine, cannabis, cocaine, methamphetamine, MDMA, LSD, ketamine, heroin, psilocybin, prescription medications not prescribed to the person) in the past 30 days.
  • History of significant allergic reaction or significant hypersensitivity to cannabis or to any of the other ingredients in the study products.
  • Current concomitant medication use that may interact with the study drug including inhibitors and inducers of CYP2CP and CYP3A4 as well as highly-protein bound drugs and drugs with a narrow therapeutic index such as warfarin, cyclosporine, and amphotericin B.
  • History of or current evidence of a significant medical condition that, in the opinion of the investigator or medical staff, will impact the participant's safety or interfere with study outcomes.
  • Evidence of current psychiatric condition (based on MINI for DSM-5).
  • Been in treatment previously for cannabis use disorder.
  • Receiving of any drug as part of a research study within the past 30 days.
  • History of epilepsy or other serious medical condition.

Recruiting US locations

  • Johns Hopkins Behavioral Pharmacology Research Unit

    Baltimore, MD 21224

    Site contact: Tory Spindle, PhD · 410-550-0529 · tspindle@jhmi.edu

Study contacts (from the official record)

  • Tory Spindle, PhD · 410-550-0529 · tspindle@jhmi.edu
  • Lindsay Howard · 410-550-0009 · lhowar29@jhmi.edu
All healthy volunteers studies in Maryland →
The Impact of Product Formulation on the Pharmacokinetics and… (NCT05602649) | Bored Studies