RecruitingEarly Phase 1NCT07434895

Repeated CBD Administration and Cannabis Outcomes

The Effects of Repeated CBD Administration on Cannabis Abuse Liability and Analgesia: A Human Laboratory Study


Sponsor

Hannah Harris

Enrollment

23 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria9

  • 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 Criteria11

  • 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).

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Interventions

DRUGCannabidiol, Medium Dose

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

DRUGCannabidiol, Higher Dose

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

DRUGActive 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).

DRUGPlacebo Cannabidiol

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

DRUGPlacebo 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).


Locations(1)

University of Kentucky

Lexington, Kentucky, United States

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NCT07434895


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