PK/PD of Vaping THC-containing Liquids vs. Smoked Cannabis

Официальное название

A Randomized Within-Subject Cross-Over Study to Compare Short-Term PK/PD Effects of Vaping THC-containing Liquids vs. Smoked Cannabis

Обзор

We will conduct a randomized, within-subjects clinical study to compare short-term pharmacokinetic (PK) and pharmacodynamic (PD) effects of Δ9-tetrahydrocannabinol (THC) vaping liquids vs. smoked cannabis containing 6 equivalent standard THC units (5 mg THC=1 Standard THC Unit (STU)) in healthy community members who are current users of both products. While smoking cannabis remains the most common mode of THC use among adults and youth, alternative modes of delivery, such as Electronic Vaping Products (EVPs), are becoming increasingly popular for the delivery of cannabinoids. Declining cannabis risk perceptions, increasing normalization of cannabis, greater legal access and availability to cannabis, ease of administration, and ability to conceal vaped THC use have likely contributed to increasing prevalence of use throughout the population across all age groups. Comparing vaping THC containing liquids with smoking cannabis can serve as an important benchmark for evaluating the delivery and effects of THC vaping products and, their relative safety

Подробное описание

PRIMARY OBJECTIVE:

I. Compare the PK/PD profiles of delta-9 tetrahydrocannabinol (THC) from equivalent standard THC doses (30mg) administered as vaped THC liquid vs. smoked cannabis using a within-subject design.

SECONDARY OBJECTIVES:

I. Safety

PRIMARY OBJECTIVE:

I. Compare the PK/PD profiles of delta-9 tetrahydrocannabinol (THC) from equivalent standard THC doses (30mg) administered as vaped THC liquid vs. smoked cannabis using a within-subject design.

SECONDARY OBJECTIVES:

I. Safety

Вмешательства

• Поведенческое Vape device
  Consume THC via vape defice
• Поведенческое Joint
  Consume THC via joint
• Препарат Marijuana via vape device
  Given via vape device
• Препарат Marijuana via joint
  Given via joint

Первичные конечные точки

• Peak Plasma Concentration (Cmax) [Срок оценки: From baseline to 360 minutes after consuming product]
• Area under the plasma concentration time curve from 0-360 minutes ((AUC^0-360) [Срок оценки: From baseline to 360 minutes after consuming product]
• Time to maximum concentration of THC in plasma (Tmax) [Срок оценки: From baseline to 360 minutes after consuming product]

Вторичные конечные точки (5)

• Incidence of adverse events [Срок оценки: Up to 360 minutes after consuming product]
• Puffing behaviors [Срок оценки: Through study completion, an average of 14 days]
• Short term effects of THC [Срок оценки: Through Study completion, an average of 14 days]
• Cognitive Performance as assessed by the Digit Symbol Substitution Task (DSST) [Срок оценки: Through study completion, an average of 14 days]
• Paced Auditory Serial Addition Task (PASET) [Срок оценки: Through study completion , an average of 14 days]

Критерии участия

Критерии включения

• Age >= 21 years of age
• Report concurrent use of commercial (medical or recreational) smoked cannabis and THC vaping cartridges for at least 3 months prior to enrollment
• Report smoking cannabis and THC- vaping liquid use at the potency level of the study product at least weekly (4x/month)
• Report of not currently trying to become pregnant (females). Women of childbearing potential must be willing to provide a urine sample and test negative prior to receiving any study-related products/procedures
• Willing to complete a THC saliva test to check for recent use (NarcoCheck Ref#:NCE-STHC-1) and semi -quantitative urinary tetrahydrocannabinol-carboxylic acid (THCA) rapid test (NarcoCheck® THC PreDosage) during baseline testing, prior to receiving any study-related products
• Participant must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Критерии исключения

• • Illegal or non-prescription drug use within the past 90 days. As detected by NacroCheck® Évolutive® (detection in human urine of the 12 most currently abused drugs) at the first session and prior to receiving any study product

• Report 2 or more drinking occasions/week with 4 or more drinks/occasion
• Report of daily nicotine use
• Current or prior diagnosis of any psychotic disorders
• Current or prior diagnosis of chronic heart conditions
• Current or prior diagnosis of any respiratory condition
• Pregnant or currently trying to become pregnant (females)
• Detection level 4-5 (>300 ng/mL) from a semi-quantitative urinary THCA rapid test (NarcoCheck® THC PreDosage)
• Unwilling or unable to follow protocol requirements
• Any condition which in the Investigator's opinion deems the participant an unsuitable candidate for participation

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

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06055231 · I 3409223 · R01DA057228

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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