Recruiting NCT07434895

Repeated CBD Administration and Cannabis Outcomes

Early Phase I Interventional Cannabis Abuse Liability Experimental Pain in Healthy Human Participants

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In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Cannabidiol, Medium Dose, Cannabidiol, Higher Dose, Active Inhaled Cannabis, Placebo Cannabidiol.
Who it may be relevant to: Registry conditions: Cannabis, Abuse Liability, Experimental Pain in Healthy Human Participants. Basic parameters: 18 years — 55 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

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

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

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

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).]
Change from Baseline-Marijuana Purchase Task: Elasticity [Time frame: Days 1 (baseline), 7, 14, measured ~3 hours post cannabis administration.]

Secondary outcome measures (3)

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).]
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).]
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.]

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.

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

United States · 1 center

NCT: NCT07434895 · 107878 · K01DA056692