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Clinical Trials/NCT02019459
NCT02019459
Completed
Phase 2

Very Low Nicotine Cigarettes in Smokers With Schizophrenia

Brown University1 site in 1 country58 target enrollmentNovember 17, 2014

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Tobacco Dependence
Sponsor
Brown University
Enrollment
58
Locations
1
Primary Endpoint
Number of cigarettes smoked per day
Status
Completed
Last Updated
8 years ago

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.

Registry
clinicaltrials.gov
Start Date
November 17, 2014
End Date
August 31, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jennifer Tidey

Principal Investigator

Brown University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of cigarettes smoked per day

Time Frame: End of 6 week intervention

Study Sites (1)

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