Varenicline Effects In Schizophrenic Smokers
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|ClinicalTrials.gov Identifier: NCT00548470|
Recruitment Status : Completed
First Posted : October 24, 2007
Results First Posted : September 5, 2017
Last Update Posted : September 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Tobacco Use Disorder Nicotine Dependance||Drug: Varenicline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Varenicline's Clinical Efficacy for Continued Smoking Abstinence When Used in the Clinical Treatment of Schizophrenic Patients Hospitalized in an Institution With a Ban on Cigarette Smoking|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||December 2010|
open label varenicline 2mg/day
Varenicline 1-2 mg/day
Other Name: Chantix
- Self Report of Smoking [ Time Frame: Baseline and during 2 months of treatment ]Patients self-report of smoking cigarettes. Patients were interviewed weekly about the number of cigarettes smoked. Number of cigarettes smoked in the past week.
- CO (Carbon Monoxide) Breathalyzer Level [ Time Frame: baseline and during 2 months of treatment ]Carbon Monoxide in breath ,parts per million
- Plasma Cotinine [ Time Frame: baseline 1 month and 2 months ]cotinine level in plasma ng/ml.
- RBANS Neuropsychological Battery [ Time Frame: baseline and month 2 of treatment ]The scale is Repeatable Battery for the Assessment to Neuropsychological Status (RBANS). This scale measures cognitive function in patients with schizophrenia. RBANS scores for list learning range from 0 to 40. RBANS Index scores for visual-spatial index, language index, and Total score range from 40-160. RBANS Total score is the sum of score of all the individual items ( items 1-12) on the RBANS scale. List Learning scores range from 0 to 40. Visual Spatial Construction index scores range from 0 to 30.. Higher scores on all these measures indicate better performance or better cognitive ability.
- Change From Baseline in Psychiatric Symptoms [ Time Frame: Baseline and 2 months later ]The Positive and Negative Syndrome Scale (PANSS) was used to measure psychiatric symptoms. Item scores ranged from 1 (Absent) to 6 (Severe) for symptoms on the Positive Scale (total subscale range: 7-42), the Negative Scale (total subscale range: 7-42), and the General Psychopathology Scale (total subscale range:16-96). All three subscales were summed for the PANSS total score (total scale range: 30-180). Higher numbers indicate more psychopathology. Therefore, if scores are reduced at post-baseline ratings, this would indicate lower psychopathology.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548470
|United States, New York|
|Manhattan Psychiatric Center|
|New York, New York, United States, 10035|
|Principal Investigator:||Robert C Smith, MD, PhD||Nathan Kline Institute of Psychiatric Research; NYU School of Medicine|