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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

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Conditions

CannabisAbuse LiabilityExperimental Pain in Healthy Human Participants

Locations

University of Kentucky

Lexington, Kentucky 40508

United States