Repeated CBD Administration and Cannabis Outcomes

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Hannah Harris
Study ID
NCT07434895
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Cannabidiol, Medium Dose — DRUG
    Active Cannabidiol: Active cannabidiol (medium dose) will be administered orally for 14 days.
  • Cannabidiol, Higher Dose — DRUG
    Description: Active Cannabidiol: Active cannabidiol (higher dose) will be administered orally for 14 days.
  • Active Inhaled Cannabis — DRUG
    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).
  • Placebo Cannabidiol — DRUG
    Inactive/Placebo Cannabidiol: Inactive/placebo cannabidiol will be administered orally for 14 days.
  • Placebo Inhaled Cannabis — DRUG
    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).

Study Details

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

Key Dates

Start date
Jun 29, 2026
Status verified
Jun 2026
Primary completion
Dec 1, 2029
Completion
Dec 1, 2029

Study Design

Enrollment
23 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.

Primary Outcome Measure

Change from Baseline-Subject-Related Outcome-VAS Drug Liking [ Time Frame: Days 1 (baseline), 7, 14, prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40508
Paul A Nuzzo, M.A.
[email protected]
859-323-0002
Hannah M Harris, Ph.D.
[email protected]

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By research site
University of Kentucky· Lexington, KY

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