Repeated CBD to change how cannabis affects mood and pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this outpatient early-phase study, healthy adult cannabis users receive repeated doses of cannabidiol (CBD) or placebo and then inhale active or placebo cannabis during laboratory sessions. Researchers compare behavioral responses and experimentally induced pain relief across medium and higher CBD dose conditions versus placebo. Participants are screened for general health, absence of other drug dependence, and must be 18–55 years old with a BMI between 18.5 and 32.0. Outcome measures include subjective effects, objective behavioral tests, and pain response following controlled cannabis exposure.

Why it matters

Who can join: the full rules

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).

Where it's running

• University of Kentucky
  Lexington, Kentucky, United States Recruiting

Study contacts

• Principal investigator: Hannah M Harris, Ph.D. — University of Kentucky
• Study coordinator: Paul A Nuzzo, M.A.
• Email: pnuzz2@email.uky.edu
• Phone: 859-323-0002

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.