Behavioral Pharmacology Associated With Cigar Smoking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Assess Beharioral/Self-Reported Aspects of Cigar Smoking
研究概览
简要总结
Lovelace Scientific Resources is conducting clinical research study for cigar smokers. This study will be evaluating the behaviors of cigar smokers and the short term effects of cigar smoking.
A cigar is defined as a cylinder of tobacco wrapped in a tobacco leaf for smoking. There are small cigars with filters that resemble cigarettes and large cigars that do not have filters. Because cigars come in so many shapes and sizes, the nicotine content varies as well. The way that a cigar smoker consumes the cigar can also have an effect on how much nicotine is absorbed. This study seeks to understand nicotine consumption and addiction in cigar smokers.
Study participation will last 1 to 4 weeks and will include 2 study-related visits. Your visits may include a physical exam, medical history review, questionnaires, blood collections, providing a urine sample, an exhaled breath test, having your vital signs collected and smoking a cigar. You will be videotaped while you smoke your cigar so that we can review the technique you use while smoking.
STUDY HYPOTHESES:
- Significant reductions in craving and withdrawal will be reported after ad libitum smoking of a cigar compared to self-report prior to cigar smoking.
- Cigar smokers will show a range of nicotine dependence, with a subset of users exceeding minimal criteria for nicotine dependence.
- Levels of nicotine, cotinine, Carbon Monoxide (CO), and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) will increase significantly from pre- to post-cigar smoking.
- Small cigar/cigarillo users will demonstrate greater levels of dependence and greater relief from craving and withdrawal compared to large cigar users.
详细描述
This study seeks to better understand dependence behaviors in small and large cigar smokers. All recruited cigar smokers will be self-defined as users on ≥ 1 day(s) per week for the past 6 months. They will not be currently using any other type of tobacco product for the past 6 months. Study subjects will smoke their own type and brand of cigar upon at least 24 hours of abstinence from all tobacco products.
Dependence (both real and perceived), withdrawal relief, and craving will be measured with existing and modified behavioral scales and assessments. In addition, smoking topography (including latency to first puff, puff number, interpuff interval, and smoking duration), self-reported inhalation behaviors, and exhaled CO will also be measured.
This is a single center, un-blinded study seeking to better understand dependence behaviors in small and large cigar smokers.
Subjects will be videotaped while smoking their cigar using a digital camcorder, and the video will immediately be burned to DVD for subsequent smoking topography scoring by two separate raters. These raters will directly observe the subject during the cigar smoking exposure.
Urine samples and serial blood samples will be collected to measure biomarkers of exposure (including nicotine, cotinine, and total NNAL) before, during, and after subjects' smoking of their usual type and brand of cigar. A urine creatinine lab test will be collected pre and post exposure to correct for excreted cotinine levels. Subjects will be instructed to empty their bladders pre cigar exposure. They will then be instructed to rehydrate based on their BMI prior to the initiation of cigar smoke exposure and after 60 minutes post cigar initiation. Hepatic and renal function will be assessed at screening to determine any metabolism problems. Subjects will be asked to bring two (2) cigars of their usual type and brand. One cigar will be used to smoke; the 2nd cigar will be used to measure total nicotine content.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to voluntarily sign the IRB approved informed consent form (ICF)
- •Willing to complete all the requirements of the study
- •Male or Female, ≥ 18 years of age
- •Female subjects must be either:
- •Surgically sterile defined as having had a hysterectomy, bilateral oophorectomy, or tubal ligation, amenorrheic for at least two years prior to screening visit, or otherwise incapable of becoming pregnant Or Willing to practice an effective method of birth control if sexually active, taking hormonal prescription oral contraceptives, progesterone implants or injections, contraceptive patch, intrauterine device, or male partner with a vasectomy. A double barrier method such as condoms, diaphragms, or cervical caps with spermicidal foam, cream, or gel, or abstinence may be used as a method of birth control
- •Must be either a primary cigar or a secondary cigar smoker. Must have a self-reported history of using cigars on ≥1 day per week for the past 6 months
- •Primary cigar users must report no significant prior use of cigarettes (< 100 cigarettes in lifetime and no use of cigarettes in the past 6 months)
- •Secondary cigar users must self-report regular use of cigarettes in the past before making the switch to cigars, and must report no use of cigarettes in the past 6 months
- •Must be able to self-report inhaling behavior as either inhaler or non-inhaler
- •Must be able to identify primary type of cigars smoked as either small cigar (including cigarillos), large cigars, or premium cigars
- •English-speaking volunteers who are not seeking treatment for smoking cessation at the time of the study
- •Have an exhaled carbon monoxide (CO) level of <10 ppm at visit 2
- •Demonstrate no clinically significant contraindications for study participation, in the judgment of the Principal Investigator
排除标准
- •Women of Child Bearing Potential (WOCBP) with a positive urine human chorionic gonadotropin (Urine β- hCG) pregnancy test within 10 days prior to Visit 2
- •Pregnant and/or nursing females
- •Use of any other type tobacco product (except cigars), non-tobacco nicotine-containing product(s), smoking cessation medications, such as varenicline (Chantix®) and bupropion (Zyban®), or NRT (Nicotine Replacement Therapy) within 60 days of study enrollment
- •Have any previous self-reported medical adverse reaction to nicotine or tobacco, (for example nausea, headache and chest pain)
- •Subjects who self-report a clinically significant concomitant disease or illness at either screening or visit 2, including but not limited to depression, schizophrenia, uncontrolled respiratory or cardiovascular disease, which in the opinion of the Principal Investigator or designee would preclude safe and /or successful completion of this study
- •Subject demonstrates an elevated liver function of ≥ 2 times the upper limit of normal at screening
- •Subject demonstrates an elevated renal function of ≥ 2 times the upper limit of normal at screening
- •Subject intends to stop smoking cigars in the next month
- •Unwilling to abstain from cigar smoking and all tobacco and nicotine use for at least 24 hours prior to exposure, Visit 2
结局指标
主要结局
Assess Beharioral/Self-Reported Aspects of Cigar Smoking
时间窗: 4 weeks
Characterize and quantify dependence, withdrawal relief, cravings, puff topography
次要结局
- Evaluate smoking exposure(4 weeks)