Status:
COMPLETED
Project 1, Study 2: The Combined Impact of Nicotine Replacement and Spectrum Cigarettes
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cigarette Smoking
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT02301325
Start Date
November 1 2014
End Date
April 1 2017
Last Update
August 15 2018
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260