Very Low Nicotine Cigarettes in Smokers With Schizophrenia

Phase 2

Completed

• Conditions: Tobacco Dependence
• Interventions: Other: standard nicotine content cigarettes; Other: Very low nicotine content cigarettes

• Registration Number: NCT02019459
• Lead Sponsor: Brown University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-18
• Study First Submitted QC: 2013-12-23
• Study First Posted: 2013-12-24
• Study Start: 2014-11-17
• Primary Completion: 2017-08-31
• Study Completion: 2017-08-31
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.8 mg nicotine with 10.5 mg tar	standard nicotine content cigarettes	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)
0.03 mg nicotine with 9 mg tar	Very low nicotine content cigarettes	SPECTRUM Cigarette: 0.03 mg (± 0.02) nicotine yield with 9 mg (± 1.5) tar

Primary Outcome Measures

Name	Time	Method
Number of cigarettes smoked per day	End of 6 week intervention

Trial Locations

Locations (1)

Brown University; 🇺🇸 Providence, Rhode Island, United States