Effect of Cannabinoids on Tobacco Product Demand and Pharmacodynamics: Cigarette Use
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Demand Intensity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Smoked THC
Each participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive combustible cigarettes containing 0.03mg and 0.80mg of nicotine.
干预措施: THC 30mg (Drug)
Smoked THC
Each participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive combustible cigarettes containing 0.03mg and 0.80mg of nicotine.
干预措施: THC 5mg (Drug)
Smoked THC
Each participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive combustible cigarettes containing 0.03mg and 0.80mg of nicotine.
干预措施: THC 0mg (Drug)
Smoked THC
Each participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive combustible cigarettes containing 0.03mg and 0.80mg of nicotine.
干预措施: Cigarette Full Nicotine (Drug)
Smoked THC
Each participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive combustible cigarettes containing 0.03mg and 0.80mg of nicotine.
干预措施: Cigarette Reduced Nicotine (Drug)
Vaporized THC
Each participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive combustible cigarettes containing 0.03mg and 0.80mg of nicotine.
干预措施: THC 30mg (Drug)
Vaporized THC
Each participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive combustible cigarettes containing 0.03mg and 0.80mg of nicotine.
干预措施: THC 5mg (Drug)
Vaporized THC
Each participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive combustible cigarettes containing 0.03mg and 0.80mg of nicotine.
干预措施: THC 0mg (Drug)
Vaporized THC
Each participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive combustible cigarettes containing 0.03mg and 0.80mg of nicotine.
干预措施: Cigarette Full Nicotine (Drug)
Vaporized THC
Each participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive combustible cigarettes containing 0.03mg and 0.80mg of nicotine.
干预措施: Cigarette Reduced Nicotine (Drug)
结局指标
主要结局
Demand Intensity
时间窗: 45 minutes after THC or placebo administration
Consumption of cigarette puffs at unconstrained price as measured by an incentivized demand task. Minimum value is 0, maximum value is not constrained. Higher scores indicate more consumption at unconstrained price (a worse outcome).
Demand Elasticity
时间窗: 45 minutes after THC or placebo administration
Changes in cigarette consumption with changes in price as measured by an incentivized demand task. There is no minimum or maximum value. Higher scores indicate greater cigarette price sensitivity (a better outcome).
次要结局
- Minnesota Nicotine Withdrawal Scale (MNWS)(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(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(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(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(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(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(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(Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.)