Repeated CBD Administration and Cannabis Outcomes

NCT07434895 | Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: 107878K01DA056692
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

marijuana; cannabidiol (CBD); marijuana users

Outcome Measures

Primary Outcomes (2)

• Change from Baseline-Subject-Related Outcome-VAS Drug Liking

  Participants rated their subjective drug liking on a standardized VAS scale (0 to 100). These Scores will indicate how participants are feeling at that moment, including questions on mood, physical symptoms, and drug effects. Low scores mean little to no drug liking. Higher scores mean greater drug liking. Raw data transformed to peak scores.

  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).

• Change from Baseline-Marijuana Purchase Task: Elasticity

  Behavioral economic demand for cannabis: how much a participant values cannabis as its "price" (cost, effort, or availability) increases. Participants indicate how much marijuana they would buy and consume at increasing, hypothetical prices. This outcome describes how sensitive marijuana consumption is to price changes and how quickly demand decreases as marijuana becomes more expensive.

  Days 1 (baseline), 7, 14, measured ~3 hours post cannabis administration.

Secondary Outcomes (3)

• Change from Baseline-Cold Pressor Test (CPT) Threshold

  Days 1 (baseline), 7, 14, This outcome will be recorded before and at two additional intervals after active and placebo cannabis administration during the laboratory session (a total of 6 measurements per session).

• Change from Baseline-Cold Pressor Test (CPT) Tolerance

  Days 1 (baseline), 7, 14, This outcome will be recorded before and at two additional intervals after active and placebo cannabis administration during the laboratory session (a total of 6 measurements per session).

• Change from Baseline-Cold Pressor Visual Analog Scale (CPT-VAS): Painful

  Days 1 (baseline), 7, 14, This outcome will be recorded before and after the CPT for a total of 6 measurements per session.

Study Arms (6)

Placebo CBD/Placebo Inhaled Cannabis

PLACEBO COMPARATOR

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; Drug: Placebo Inhaled Cannabis

Placebo CBD/Active Inhaled Cannabis

EXPERIMENTAL

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; Drug: Placebo Cannabidiol

CBD (Medium Dose)/Placebo Inhaled Cannabis

EXPERIMENTAL

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; Drug: Placebo Inhaled Cannabis

CBD (Medium Dose)/Active Inhaled Cannabis

EXPERIMENTAL

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; Drug: Active Inhaled Cannabis

CBD (Higher Dose)/Placebo Inhaled Cannabis

EXPERIMENTAL

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; Drug: Placebo Inhaled Cannabis

CBD (Higher Dose)/Active Inhaled Cannabis

EXPERIMENTAL

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; Drug: Active Inhaled Cannabis

Interventions

Cannabidiol, Medium Dose DRUG

Active Cannabidiol: Active cannabidiol (medium dose) will be administered orally for 14 days.

CBD (Medium Dose)/Active Inhaled Cannabis; CBD (Medium Dose)/Placebo Inhaled Cannabis

Cannabidiol, Higher Dose DRUG

Description: Active Cannabidiol: Active cannabidiol (higher dose) will be administered orally for 14 days.

CBD (Higher Dose)/Active Inhaled Cannabis; CBD (Higher Dose)/Placebo Inhaled Cannabis

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).

CBD (Higher Dose)/Active Inhaled Cannabis; CBD (Medium Dose)/Active Inhaled Cannabis; Placebo CBD/Active Inhaled Cannabis

Placebo Cannabidiol DRUG

Inactive/Placebo Cannabidiol: Inactive/placebo cannabidiol will be administered orally for 14 days.

Placebo CBD/Active Inhaled Cannabis; Placebo CBD/Placebo Inhaled Cannabis

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).

CBD (Higher Dose)/Placebo Inhaled Cannabis; CBD (Medium Dose)/Placebo Inhaled Cannabis; Placebo CBD/Placebo Inhaled Cannabis

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hannah Harris: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40508, United States

RECRUITING

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Hannah M Harris, Ph.D.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul A Nuzzo, M.A.

CONTACT

859-323-0002; pnuzz2@email.uky.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: February 27, 2026
• Study Start (Estimated): June 29, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)