Tobacco Dependence
Conditions
Brief summary
Smokers with serious mental illness including those with schizophrenia and bipolar disorder infrequently attempt and attain sustained smoking abstinence and have a 25-year shorter lifespan due to smoking-related illness. This study will examine whether reducing the nicotine content of cigarettes to non-addicting levels is a viable method of reducing smoking in smokers with serious mental illness. Smokers will be randomized to one of two experimental conditions: 1) very low nicotine content (VLNC) cigarettes or 2) normal nicotine content (NNC) cigarettes. Participants will be assessed for patterns of tobacco use, biomarkers of exposure, subjective responses (e.g., satisfaction, craving, withdrawal symptoms), psychiatric symptoms, cognitive performance, smoking cue reactivity and smoking topography.
Interventions
Sponsors
National Institute on Drug Abuse (NIDA)
University of Pittsburgh
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-70 * Schizophrenia, schizoaffective disorder or bipolar disorder * Smoke an average of at least 10 cigarettes per day for at least 1 year * Breath carbon monoxide (CO) levels \>8 ppm (if ≤ 8 ppm, then nicotine (NicAlert) Strip \> 2)
Exclusion criteria
* Pregnant or nursing * Seeking treatment for smoking * Medical contraindications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of cigarettes smoked per day | End of 6 week intervention |
Countries
United States
Outcome results
None listed