Very Low Nicotine Cigarettes in Smokers With Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-17

Study Completion Date

2017-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Tobacco Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

standard nicotine content cigarettes

Intervention Type OTHER

0.03 mg nicotine with 9 mg tar

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

Group Type EXPERIMENTAL

Very low nicotine content cigarettes

Intervention Type OTHER

Interventions

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Very low nicotine content cigarettes

Intervention Type OTHER

standard nicotine content cigarettes

Intervention Type OTHER

Eligibility Criteria

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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)