Project 1, Study 2: The Combined Impact of Nicotine Replacement and Spectrum Cigarettes

Inclusion criteria

• Age 18+
• 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)

Exclusion criteria

• 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
• Used any tobacco products beyond normal use for more than one day
• Used any nicotine replacement products or smoking cessation medications for more than one day
• Having participated in Project 1, Study 1 (PRO11060292)
• Having participated in Project 1, Study 1C (PRO14040384)
• Household member enrolled in the study concurrently
• Significant prior adverse reactions to adhesives or latex
• Participant has a condition that interferes/does not allow for the collection of eligibility criteria