Very Low Nicotine Cigarettes in Smokers With Schizophrenia

Brown University

Status and phase: Completed; Phase 2

Conditions: Tobacco Dependence

Treatments: Other: standard nicotine content cigarettes; Other: Very low nicotine content cigarettes

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02019459

5U54DA031659-03

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups

0.8 mg nicotine with 10.5 mg tar

Active Comparator group

Description:

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)

Treatment:

Other: standard nicotine content cigarettes

0.03 mg nicotine with 9 mg tar

Experimental group

Description:

SPECTRUM Cigarette: 0.03 mg (± 0.02) nicotine yield with 9 mg (± 1.5) tar

Treatment:

Other: Very low nicotine content cigarettes