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NCT Number: NCT07434895

Repeated CBD Administration and Cannabis Outcomes

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

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Key information

Conditions

Cannabis Abuse Liability Chemically-Induced Disorders Experimental Pain in Healthy Human Participants Marijuana Abuse Mental Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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).

Primary outcomes

  1. 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).

    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.

  2. Change from Baseline-Marijuana Purchase Task: Elasticity

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

    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.

Secondary outcomes

  1. Change from Baseline-Cold Pressor Test (CPT) Threshold

    Time frame: 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).

    Participants first immerse a dominant hand into the warm-water bath for 2 minutes. The participants are then instructed to immerse the dominanat hand in the cold-water bath and report when pain is first experienced, and to keep the hand submerged as long as possible, and to withdraw the hand from the water when the sensation becomes uncomfortable. Latency (in seconds) to first pain sensations (threshold) will be measured and recorded.

  2. Change from Baseline-Cold Pressor Test (CPT) Tolerance

    Time frame: 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).

    Participants first immerse a dominant hand into the warm-water bath for 2 minutes. The participants are then instructed to immerse the dominant hand in the cold-water bath and report when pain is first experienced, and to keep the hand submerged as long as possible, and to withdraw the hand from the water when the sensation becomes uncomfortable. Latency to withdrawal from the water (tolerance) will be measured and recorded.

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

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

    Participants first immerse a dominant hand in the warm-water bath for 2 minutes. The participants are then instructed to immerse the dominant hand in the cold-water bath and report when pain is first experienced, and to keep the hand submerged as long as possible, and to withdraw the hand from the water when the sensation becomes uncomfortable. Participants will report how painful the pain was on a visual analog scale. Low scores mean little to no pain. Higher scores mean greater pain. Raw data transformed to peak scores.

Study contacts

Contact information is provided by the study sponsor or research team.

Paul A Nuzzo, M.A.

CONTACT

[email protected]

859-323-0002

Sponsors and collaborators

Lead sponsor

Hannah Harris

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

The Effects of Repeated CBD Administration on Cannabis Abuse Liability and Analgesia: A Human Laboratory Study

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 27, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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