Repeated CBD to change how cannabis affects mood and pain
The Effects of Repeated CBD Administration on Cannabis Abuse Liability and Analgesia: A Human Laboratory Study
This study will test whether taking CBD repeatedly changes the behavioral effects and pain relief experienced by adult cannabis users.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 23 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT07434895 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–55 who regularly use cannabis, are otherwise healthy, not seeking treatment for cannabis or drug use, and meet BMI and contraception requirements for females.
Not a fit: People with physiologic dependence on opioids/benzodiazepines/barbiturates/alcohol, significant chronic medical conditions, pregnant individuals, or those seeking treatment for cannabis use are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, repeated CBD could reduce unwanted behavioral effects of cannabis or improve its pain-relieving profile for users.
How similar studies have performed: Some small human and preclinical studies suggest CBD can modify cannabis effects, but findings are mixed and not yet conclusive.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lexington, Kentucky
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.