Recruiting
Early Phase 1

Cannabidiol

Sponsor:

Hannah Harris

Code:

NCT07434895

Conditions

Cannabis

Abuse Liability

Experimental Pain in Healthy Human Participants

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Cannabidiol, Medium Dose

Cannabidiol, Higher Dose

Active Inhaled Cannabis

Placebo Cannabidiol

Placebo Inhaled Cannabis

Study Details

Brief summary:

This outpatient study examines how cannabidiol (CBD) affects the behavioral and pain-relieving effects of cannabis.

Conditions

Cannabis

Abuse Liability

Experimental Pain in Healthy Human Participants

Study ID

NCT07434895

Start date

Aug 5, 2026

Status verified date

Aug, 2026

Completion date

Dec 1, 2029

Anticipated

Primary completion date

Dec 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

  • English-speaking, literate adults,
  • Male or female,
  • Between the ages of 18-55,
  • Body Mass Index from 18.5-32.0 kg/m2,
  • Not currently seeking treatment for cannabis or drug use,
  • Able to provide written informed consent and perform all study procedures,
  • If female, a negative pregnancy test and use of an effective form of contraception during study participation (e.g., oral contraceptive, abstinence, barrier method),
  • Negative urine drug test for drugs of abuse (other than cannabis) prior to every Laboratory Session, and
  • Otherwise healthy as determined by the investigator based on medical history, physical examination, vital signs, and laboratory chemistries.

Exclusion Criteria:

  • Physiologic drug dependence on opioids, benzodiazepines, barbiturates, and/or alcohol that would require medical management,
  • Clinically significant acute medical problem (e.g., infection) or chronic medical problem requiring daily medication or ongoing medical care (e.g., hypertension, cardiovascular disease, diabetes, respiratory disorders \[e.g., asthma, COPD\]),
  • Current or past history of major psychiatric disorder that would limit ability to participate in the study,
  • Use of cannabis exclusively for medical reasons (no recreational use reported),
  • Current, unrelenting chronic pain that prevents participation (i.e., unable to sit in chair for 8 hours),
  • Currently using daily prescription medications to manage medical conditions or any drug that could interfere with the study, including potent CYP2C9, CYP3A4, or CYP2C19 inducers,
  • Clinically significant abnormal ECG (as determined by study physician/cardiologist),
  • Clinically significant abnormal laboratory findings,
  • History of seizure disorder,
  • Clinically significant history of head injuries requiring medical management or long lasting sequalae, and
  • Self-report of past 30-day use of synthetic cannabis (i.e., K2, Spice).

Study Design

Enrollment

23 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Placebo CBD/Placebo Inhaled Cannabis

Participants will receive non-therapeutic, experimental doses of placebo/inactive cannabidiol in combination with non-therapeutic, placebo/inactive vaporized marijuana. Inactive cannabidiol and inactive marijuana will be administered once per session. It is possible to receive both inactive drugs on the same day.

Inactive/Placebo Cannabidiol: Placebo/inactive cannabidiol will be administered orally.

Inactive/Placebo: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer.

experimental: Placebo CBD/Active Inhaled Cannabis

Participants will receive a non-therapeutic, experimental dose of inactive/placebo cannabidiol in combination with non-therapeutic, active vaporized marijuana. It is possible to receive inactive cannabidiol and active marijuana on the same day.

Inactive/Placebo Cannabidiol: Active cannabidiol will be administered orally.

Active Marijuana: Experimental, non-therapeutic administration of an active marijuana dose will be administered through a vaporizer.

experimental: CBD (Medium Dose)/Placebo Inhaled Cannabis

Participants will receive a non-therapeutic, experimental dose of active cannabidiol in combination with non-therapeutic, inactive vaporized marijuana. It is possible to receive active cannabidiol, and inactive marijuana on the same day.

Active Cannabidiol: Active cannabidiol will be administered orally.

Inactive/Placebo Marijuana: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer.

experimental: CBD (Medium Dose)/Active Inhaled Cannabis

Participants will receive non-therapeutic, experimental doses of active cannabidiol in combination with non-therapeutic, experimental doses of active vaporized marijuana. Cannabidiol and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day.

Vaporized Marijuana: Active Marijuana administered through a vaporizer

Cannabidiol: Active cannabidiol will be administered orally

experimental: CBD (Higher Dose)/Placebo Inhaled Cannabis

Participants will receive a non-therapeutic, experimental dose of active cannabidiol in combination with non-therapeutic, inactive vaporized marijuana. It is possible to receive active cannabidiol, and inactive marijuana on the same day.

Active Cannabidiol: Active cannabidiol will be administered orally.

Inactive/Placebo Marijuana: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer.

experimental: CBD (Higher Dose)/Active Inhaled Cannabis

Participants will receive non-therapeutic, experimental doses of active cannabidiol in combination with a non-therapeutic, experimental dose of active vaporized marijuana. Active cannabidiol and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day.

Active Cannabidiol: Active cannabidiol will be administered orally.

Active Marijuana: Active Marijuana will be administered through a vaporizer.

Interventions

Cannabidiol, Medium Dose

Active Cannabidiol: Active cannabidiol (medium dose) will be administered orally for 14 days.

Cannabidiol, Higher Dose

Description: Active Cannabidiol: Active cannabidiol (higher dose) will be administered orally for 14 days.

Active Inhaled Cannabis

Active Marijuana: Active Marijuana (active inhaled cannabis) will be administered through a vaporizer once per study session day (Day 1, 7, 14) per block (3 blocks total).

Placebo Cannabidiol

Inactive/Placebo Cannabidiol: Inactive/placebo cannabidiol will be administered orally for 14 days.

Placebo Inhaled Cannabis

Inactive/Placebo Marijuana: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer at each study session day (Days 1, 7, 14) per block (3 blocks total).

Primary outcome measure

  • Change from Baseline-Subject-Related Outcome-VAS Drug Liking [ Time Frame: Days 1 (baseline), 7, 14, prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session). ]
  • Change from Baseline-Marijuana Purchase Task: Elasticity [ Time Frame: Days 1 (baseline), 7, 14, measured ~3 hours post cannabis administration. ]

Central Contacts and Locations

Central contacts

Paul A Nuzzo, M.A.

859-323-0002pnuzz2@email.uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40508

Contacts

Paul A Nuzzo, M.A.

859-323-0002pnuzz2@email.uky.edu

Hannah M Harris, Ph.D.

hannah.harris@uky.edu

More Information

Sponsor

Hannah Harris

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • marijuana
  • cannabidiol (CBD)
  • marijuana users

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hannah Harris on 2026-08-12.