Repeated CBD Administration and Cannabis Outcomes

Официальное название

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

Обзор

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

Вмешательства

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

Первичные конечные точки

• Change from Baseline-Subject-Related Outcome-VAS Drug Liking [Срок оценки: 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 [Срок оценки: Days 1 (baseline), 7, 14, measured ~3 hours post cannabis administration.]

Вторичные конечные точки (3)

• Change from Baseline-Cold Pressor Test (CPT) Threshold [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Days 1 (baseline), 7, 14, This outcome will be recorded before and after the CPT for a total of 6 measurements per session.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• University of Kentucky — Lexington

Идентификаторы

NCT: NCT07434895 · 107878 · K01DA056692

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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