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NCT02019459 Clinical Trial

Very Low Nicotine Cigarettes in Smokers With Schizophrenia

Tobacco Dependence Clinical Trial

Official title:
Very Low Nicotine Cigarettes in Smokers With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02019459
Other study ID # 5U54DA031659-03
Secondary ID
Status Completed
Phase Phase 2
First received December 18, 2013
Last updated April 5, 2018
Start date November 17, 2014
Est. completion date August 31, 2017

Study information
Verified date April 2018
Source Brown University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 58
Est. completion date August 31, 2017
Est. primary completion date August 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Very low nicotine content cigarettes

• standard nicotine content cigarettes

Locations
Country Name City State
United States Brown University Providence Rhode Island

Sponsors (3)
Lead Sponsor Collaborator
Brown University National Institute on Drug Abuse (NIDA), University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of cigarettes smoked per day End of 6 week intervention
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