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

Exclusion Criteria

• •1. Intention to quit smoking in the next 30 days
• •2. Currently seeking treatment for smoking cessation
• •3. Currently using nicotine replacement therapies or other pharmacotherapies as cessation aid (intermittent use acceptable)
• •4. Significant prior adverse reaction to nicotine replacement as determined by the licensed medical professional.
• •5. A quit attempt in the past 30 days resulting in greater than 3 days of abstinence
• •6. Using other tobacco products more than 9 days in the past 30 days
• •7. 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)
• •8. Significant unstable psychiatric conditions (any significant change in psychiatric symptoms during the past 3 months as determined by the licensed medical professional)
• •9. Schizophrenia and schizoaffective disorder
• •10. 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.
• •11. Breath alcohol level \> 0.01
• •12. Binge drinking alcohol (more than 9 days in the past 30 days, 4/5 drinks in a 2 hour period (female/male))
• •13. Pregnant, trying to become pregnant or breastfeeding
• •14. Smoking 'roll your own cigarettes' exclusively
• •15. 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
• •16. CO reading \>80 ppm
• •17. Systolic BP greater than or equal to 160
• •* Participants failing for blood pressure will be allowed to re-screen once.
• •18. Diastolic BP greater than or equal to 100
• •* Participants failing for blood pressure will be allowed to re-screen once.
• •19. Systolic BP below 90
• •* Participants failing for blood pressure will be allowed to re-screen once.
• •20. Diastolic BP below 50
• •* Participants failing for blood pressure will be allowed to re-screen once.
• •21. Heart rate greater than or equal to 105 bpm
• •* Participants failing for heart rate will be allowed to re-screen once.
• •22. Heart rate lower than 45 bpm
• •* Participants failing for heart rate will be allowed to re-screen once.
• •23. 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).
• •24. Inability to independently read and comprehend the consent form and other written study materials and measures.
• •25. 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
• •26. Having participated in Project 1, Study 1 (PRO11060292)
• •27. Having participated in Project 1, Study 1C (PRO14040384)
• •28. Household member enrolled in the study concurrently
• •29. Significant prior adverse reactions to adhesives or latex
• •30. Participant has a condition that interferes/does not allow for the collection of eligibility criteria