Effect of Cannabis on Cigarette Use Behavior

Официальное название

Effect of Cannabinoids on Tobacco Product Demand and Pharmacodynamics: Cigarette Use

Обзор

The purpose of this study is to determine the impact of tetrahydrocannabinol (THC) administration on motivational, subjective, and physiological effects of cigarettes. The study's goals are to test demand for cigarettes, tobacco craving, affect, heart rate, blood pressure, expired breath carbon monoxide, and cognitive performance. Researchers will compare multiple doses of THC and a placebo in participants who smoke cigarettes and either smoke or vape THC in the laboratory.

Подробное описание

A full-factorial laboratory study will be conducted to determine the impact of acute THC administration on the dose-related motivational, subjective, and physiological effects of combustible cigarettes. This study will employ a double-blind, placebo-controlled, within-subjects crossover design to examine the dose-effects of THC on combustible tobacco use. The study will use multiple active doses of THC and placebo (0, 5, and 30 mg; corresponding to 0, 1, and 6 standard THC unit doses). Participants will be randomized to either smoked or vaporized THC administration using a between-subjects approach to evaluate the effect of congruent versus incongruent routes of THC and tobacco administration on study outcomes.

Вмешательства

• Препарат THC 30mg
  High dose of THC (30 mg)
• Препарат THC 5mg
  Low dose of THC (5 mg)
• Препарат THC 0mg
  Placebo dose of THC (0 mg)
• Препарат Cigarette Full Nicotine
  Full nicotine cigarette
• Препарат Cigarette Reduced Nicotine
  Reduced nicotine cigarette

Первичные конечные точки

• Demand Intensity [Срок оценки: 45 minutes after THC or placebo administration]
• Demand Elasticity [Срок оценки: 45 minutes after THC or placebo administration]

Вторичные конечные точки (8)

• Minnesota Nicotine Withdrawal Scale (MNWS) [Срок оценки: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.]
• Brief Questionnaire of Smoking Urges (QSU - Brief) Factor 1 [Срок оценки: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.]
• Brief Questionnaire of Smoking Urges (QSU - Brief) Factor 2 [Срок оценки: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.]
• Drug Effect Questionnaire for Like Drug [Срок оценки: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.]
• Heart Rate [Срок оценки: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.]
• Diastolic Blood Pressure [Срок оценки: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.]
• Systolic Blood Pressure [Срок оценки: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.]
• Divided Attention Task (DAT) Performance [Срок оценки: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.]

Критерии участия

Критерии включения

• Healthy non-treatment seeking adults aged 21 or older
• Report daily use of combustible tobacco cigarettes
• Biological confirmation of cigarette use: have an expired carbon monoxide (CO) level of more than 5 ppm and a positive urine cotinine test at screening
• Report current use of cannabis (at least 1 occasion per week)
• Have experience with the inhalation route of administration for cannabis
• Biological confirmation of cannabis use: have a positive urinary THC drug test at screening.
• For women of children bearing potential and men with female partners of child-bearing potential, must be willing to use an effective form of contraception during the study.

Критерии исключения

• Report current intention to reduce or quit cannabis or tobacco use within the next 30 days
• Meet Diagnostic and Statistical Manual (DSM-5) criteria for a substance use disorder other than alcohol, cannabis, or nicotine
• Test positive for illicit drugs other than cannabis and tobacco
• Positive breath alcohol test at study admission
• Have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity
• Have a lifetime history of suicidal behavior (i.e. past suicide attempt), or current suicidal behavior or ideation as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
• Are currently pregnant, planning to become pregnant in the next three months or are currently breastfeeding
• Have a history of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina)
• Are currently enrolled in another clinical trial or have received any drug as part of a research study within 30 days of study participation.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Четверное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Johns Hopkins University Behavioral Pharmacology Research Unit — Baltimore

Идентификаторы

NCT: NCT06609083 · IRB00435111 · R01DA058624

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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