Tobacco Dependence
Conditions
Keywords
Biomarkers of exposure, Compensatory smoking, Nicotine dependence, Reduced nicotine cigarettes, Tobacco withdrawal
Brief summary
Project 1, Study 1 will evaluate the relationship between nicotine yield of very low nicotine content cigarettes and 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, cognitive function, cardiovascular function, and perceived risk. We will also consider differences between conditions in compliance with product use.
Interventions
Sponsors
National Institute on Drug Abuse (NIDA)
Masonic Cancer Center, University of Minnesota
Brown University
Johns Hopkins University
University of California, San Francisco
M.D. Anderson Cancer Center
University of Pennsylvania
Duke University
H. Lee Moffitt Cancer Center and Research Institute
University of Minnesota
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18+ * Smoke an average of at least five cigarettes per day for at least 1 year * Breath CO levels \> 8 ppm (if ≤ 8 ppm, then NicAlert Strip \> 2)
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) * 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 at each site) * Significant unstable psychiatric conditions (Any significant change in psychiatric symptoms during the past 3 months as determined by the licensed medical professional at each site) * Schizophrenia and schizoaffective disorder * Psychiatric medication changes in the past 3 months * Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP 1. Marijuana will be tested for but will not be an exclusionary criterion. 2. Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded. 3. Participants failing the toxicology screen will be allowed to re-screen once. * Blood alcohol level \> 0.01 a. Participants failing the blood alcohol screen will be allowed to re-screen once. * Binge drinking alcohol (more than 9 days in the past 30 days, 4/5 in a 2 hour period(female/male)) * Pregnant or breastfeeding * Smoking 'roll your own cigarettes' exclusively * Currently taking anticonvulsant medication * CO reading \>80 ppm * Systolic BP greater than or equal to 160 a. Participants failing for blood pressure will be allowed to re-screen once. * Diastolic BP greater than or equal to 100 a. Participants failing for blood pressure will be allowed to re-screen once. * Systolic BP below 90 a. Participants failing for blood pressure will be allowed to re-screen once. * Diastolic BP below 50 a. Participants failing for blood pressure will be allowed to re-screen once. * Heart rate greater than or equal to 115bpm a. Participants failing for heart rate will be allowed to re-screen once. * Heart rate lower than 45bpm a. 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 10 years * 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: 1. Smoked a cigarette that was not his/her usual brand cigarette for more than one day 2. Used any tobacco products beyond normal use for more than one day 3. Used any nicotine replacement products or smoking cessation medications for more than one day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of cigarettes smoked per day | End of 6 week intervention |
Countries
United States
Outcome results
None listed