Very Low Nicotine Cigarettes in Smokers With Schizophrenia
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Brown University
- Enrollment
- 58
- Locations
- 2
- Primary Endpoint
- Number of cigarettes smoked per day
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
0.8 mg nicotine with 10.5 mg tar
SPECTRUM Cigarette: 0.8 (±0.15) mg nicotine yield with 9 (±1.5) mg tar (standard nicotine and tar yields of commercially-available cigarettes; control condition)
Intervention: standard nicotine content cigarettes (Other)
0.03 mg nicotine with 9 mg tar
SPECTRUM Cigarette: 0.03 mg (± 0.02) nicotine yield with 9 mg (± 1.5) tar
Intervention: Very low nicotine content cigarettes (Other)
Outcomes
Primary Outcomes
Number of cigarettes smoked per day
Time Frame: End of 6 week intervention
Secondary Outcomes
No secondary outcomes reported
Investigators
Jennifer Tidey
Principal Investigator
Brown University