NCT07434895EARLY_PHASE1RecruitingAccepts Healthy Volunteers
Repeated CBD Administration and Cannabis Outcomes
Hannah Harris
Start Date
6/29/2026
Completion Date
12/1/2029
Summary
This outpatient study examines how cannabidiol (CBD) affects the behavioral and pain-relieving effects of cannabis.
Eligibility Criteria
Age Range: 18 years to 55 years
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).
Interventions
DRUG
Cannabidiol, Medium Dose
DRUG
Cannabidiol, Higher Dose
DRUG
Active Inhaled Cannabis
DRUG
Placebo Cannabidiol
DRUG
Placebo Inhaled Cannabis
Conditions
CannabisAbuse LiabilityExperimental Pain in Healthy Human Participants
Locations
University of Kentucky
Lexington, Kentucky 40508
United States