Project 1, Study 2: The Combined Impact of Nicotine Replacement and Spectrum Cigarettes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Cigarettes Smoked Per Day
研究概览
简要总结
Project 1, Study 2 will evaluate the impact of very low nicotine content cigarettes with and without transdermal nicotine on cigarettes smoked per day, nicotine exposure, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use, cigarette characteristics, cue reactivity, cardiovascular function, perceived risk and cue reactivity. The investigators will also consider differences between conditions in compliance with product use and the ability to abstain from smoking when provided a financial incentive for abstinence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Smoke an average of at least five cigarettes per day for the last year with no periods of continuous abstinence longer than 30 days.
- •Breath CO levels > or = 10 ppm (if < 10 ppm, then NicAlert Strip = 6)
- •Fulfills need for participants in the required strata (menthol status)
排除标准
- •Intention to quit smoking in the next 30 days
- •Currently seeking treatment for smoking cessation
- •Currently using nicotine replacement therapies or other pharmacotherapies as cessation aid (intermittent use acceptable)
- •Significant prior adverse reaction to nicotine replacement as determined by the licensed medical professional.
- •A quit attempt in the past 30 days resulting in greater than 3 days of abstinence
- •Using other tobacco products more than 9 days in the past 30 days
- •Significant unstable medical conditions (any significant change in a serious medical condition occurring during the past 3 months including cardiovascular disease, COPD, and cancer, as determined by the licensed medical professional)
- •Significant unstable psychiatric conditions (any significant change in psychiatric symptoms during the past 3 months as determined by the licensed medical professional)
- •Schizophrenia and schizoaffective disorder
- •Positive toxicology screen for any of the following drugs: marijuana, cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP
- •Participants with valid prescriptions for any toxicology results will not be excluded.
- •Breath alcohol level > 0.01
- •Binge drinking alcohol (more than 9 days in the past 30 days, 4/5 drinks in a 2 hour period (female/male))
- •Pregnant, trying to become pregnant or breastfeeding
- •Smoking 'roll your own cigarettes' exclusively
- •Currently taking any one of the following medications:
- •Phenytoin [Brand Name: Dilantin]
- •Carbamazepine [Brand Name: Tegretol, Carbatrol, Equetro, Epitol]
- •Oxcarbazepine [Brand Name: Trileptal]
- •Primidone [Brand Name: Mysoline]
- •Phenobarbital
- •Bendamustine [Brand Name: Treanda]
- •Clopidogrel [Brand Name: Plavix]
- •Clozapine [Brand Name: Clozaril, FazaClo]
- •Erlotinib [Brand Name: Tarceva]
- •Flecainide [Brand Name: Tambocor]
- •Fluvoxamine [Brand Name: Luvox]
- •Irinotecan [Brand Name: Camptosar]
- •Olanzapine [Brand Name: Zyprexa]
- •Ropinirole [Brand Name: Requip]
- •Tacrine [Brand Name: Cognex]
- •Theophylline [Brand Name: Theo Dur]
- •Estradiol
- •CO reading >80 ppm
- •Systolic BP greater than or equal to 160
- •Participants failing for blood pressure will be allowed to re-screen once.
- •Diastolic BP greater than or equal to 100
- •Participants failing for blood pressure will be allowed to re-screen once.
- •Systolic BP below 90
- •Participants failing for blood pressure will be allowed to re-screen once.
- •Diastolic BP below 50
- •Participants failing for blood pressure will be allowed to re-screen once.
- •Heart rate greater than or equal to 105 bpm
- •Participants failing for heart rate will be allowed to re-screen once.
- •Heart rate lower than 45 bpm
- •Participants failing for heart rate will be allowed to re-screen once.
- •Indicating any suicidal ideation in the past month or suicide attempts in the past 5 years (if within the past 6-10 years, LMP approval required).
- •Inability to independently read and comprehend the consent form and other written study materials and measures.
- •Having participated in a research study during the past three months in which the participant:
- •Smoked a cigarette that was not his/her usual brand cigarette for more than one day
- 另有 7 项未显示
研究组 & 干预措施
0.03 mg Nicotine Cigarette
Participants will be assigned to smoke 0.03 mg nicotine Spectrum cigarettes
干预措施: Smoking research cigarettes with or without NRT (Behavioral)
0.03 mg Nicotine Cigarette and NRT
Participants will be assigned to smoke 0.03 mg nicotine Spectrum cigarettes and use nicotine replacement patches.
干预措施: Smoking research cigarettes with or without NRT (Behavioral)
0.80 mg Nicotine Cigarette
Participants will be assigned to smoke 0.80 mg nicotine Spectrum cigarettes.
干预措施: Smoking research cigarettes with or without NRT (Behavioral)
0.80 mg Nicotine Cigarette and NRT
Participants will be assigned to smoke 0.80 mg nicotine Spectrum cigarettes and use nicotine replacement patches.
干预措施: Smoking research cigarettes with or without NRT (Behavioral)
结局指标
主要结局
Cigarettes Smoked Per Day
时间窗: Six Weeks
次要结局
未报告次要终点