Repeated CBD Administration and Cannabis Outcomes

Purpose

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

Conditions

  • Cannabis
  • Abuse Liability
  • Experimental Pain in Healthy Human Participants

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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).

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo CBD/Placebo Inhaled Cannabis 		Participants will receive non-therapeutic, experimental doses of placebo/inactive cannabidiol in combination with non-therapeutic, placebo/inactive vaporized marijuana. Inactive cannabidiol and inactive marijuana will be administered once per session. It is possible to receive both inactive drugs on the same day. Inactive/Placebo Cannabidiol: Placebo/inactive cannabidiol will be administered orally. Inactive/Placebo: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer.
  • Drug: Placebo Cannabidiol
    Inactive/Placebo Cannabidiol: Inactive/placebo cannabidiol will be administered orally for 14 days.
  • Drug: Placebo 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).
Experimental
Placebo CBD/Active Inhaled Cannabis 		Participants will receive a non-therapeutic, experimental dose of inactive/placebo cannabidiol in combination with non-therapeutic, active vaporized marijuana. It is possible to receive inactive cannabidiol and active marijuana on the same day. Inactive/Placebo Cannabidiol: Active cannabidiol will be administered orally. Active Marijuana: Experimental, non-therapeutic administration of an active marijuana dose will be administered through a vaporizer.
  • Drug: Active 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).
  • Drug: Placebo Cannabidiol
    Inactive/Placebo Cannabidiol: Inactive/placebo cannabidiol will be administered orally for 14 days.
Experimental
CBD (Medium Dose)/Placebo Inhaled Cannabis 		Participants will receive a non-therapeutic, experimental dose of active cannabidiol in combination with non-therapeutic, inactive vaporized marijuana. It is possible to receive active cannabidiol, and inactive marijuana on the same day. Active Cannabidiol: Active cannabidiol will be administered orally. Inactive/Placebo Marijuana: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer.
  • Drug: Cannabidiol, Medium Dose
    Active Cannabidiol: Active cannabidiol (medium dose) will be administered orally for 14 days.
  • Drug: Placebo 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).
Experimental
CBD (Medium Dose)/Active Inhaled Cannabis 		Participants will receive non-therapeutic, experimental doses of active cannabidiol in combination with non-therapeutic, experimental doses of active vaporized marijuana. Cannabidiol and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Vaporized Marijuana: Active Marijuana administered through a vaporizer Cannabidiol: Active cannabidiol will be administered orally
  • Drug: Cannabidiol, Medium Dose
    Active Cannabidiol: Active cannabidiol (medium dose) will be administered orally for 14 days.
  • Drug: Active 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).
Experimental
CBD (Higher Dose)/Placebo Inhaled Cannabis 		Participants will receive a non-therapeutic, experimental dose of active cannabidiol in combination with non-therapeutic, inactive vaporized marijuana. It is possible to receive active cannabidiol, and inactive marijuana on the same day. Active Cannabidiol: Active cannabidiol will be administered orally. Inactive/Placebo Marijuana: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer.
  • Drug: Cannabidiol, Higher Dose
    Description: Active Cannabidiol: Active cannabidiol (higher dose) will be administered orally for 14 days.
  • Drug: Placebo 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).
Experimental
CBD (Higher Dose)/Active Inhaled Cannabis 		Participants will receive non-therapeutic, experimental doses of active cannabidiol in combination with a non-therapeutic, experimental dose of active vaporized marijuana. Active cannabidiol and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Active Cannabidiol: Active cannabidiol will be administered orally. Active Marijuana: Active Marijuana will be administered through a vaporizer.
  • Drug: Cannabidiol, Higher Dose
    Description: Active Cannabidiol: Active cannabidiol (higher dose) will be administered orally for 14 days.
  • Drug: Active 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).

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40508
Contact:
Paul A Nuzzo, M.A.
859-323-0002
pnuzz2@email.uky.edu

More Details

NCT ID
NCT07434895
Status
Recruiting
Sponsor
Hannah Harris

Study Contact

Paul A Nuzzo, M.A.
859-323-0002
pnuzz2@email.uky.edu