Project 1, Study 2: The Combined Impact of Nicotine Replacement and Spectrum Cigarettes
Completed · Not applicable
Conditions studied: Cigarette Smoking
In brief
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.
Key facts
- Study ID
- NCT02301325
- Run by
- Wake Forest University Health Sciences
- People needed
- 240
- Starts
- 2014-11-01
- Expected to finish
- 2017-04-01
- Last updated by the study team
- 2018-08-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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]
Where it is running
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.