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Completed

NCT Number: NCT00548470

Varenicline Effects In Schizophrenic Smokers

This is an open label pre-post study of the effects of clinical treatment with varenicline on 1) decreasing smoking in schizophrenic patients, 2) improving selected cognitive measures in schizophrenic patients, and 3) psychopathology in schizophrenic patients. Patients are assessed on subjective and objective measures of smoking, selected cognitive measures, and special chemical measures, during baseline testing and during 8 weeks of treatment with varenicline (1-2 mg/day).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Manhattan Psychiatric Center

New York, 10035, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical Diagnosis of Schizophrenia or Schizoaffective Psychosis
  • Recent History of Cigarette smoking
  • Ages 18-65

Treatment and study plan

Varenicline

Drug

Varenicline 1-2 mg/day

Other names: Chantix

Primary outcomes

  1. 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.

  2. CO (Carbon Monoxide) Breathalyzer Level

    Time frame: baseline and during 2 months of treatment

    Carbon Monoxide in breath ,parts per million

  3. Plasma Cotinine

    Time frame: baseline 1 month and 2 months

    cotinine level in plasma ng/ml.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Nathan Kline Institute for Psychiatric Research

Other

Collaborators

  • University of Illinois at Chicago

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Oct 24, 2007
Registry last updated
Sep 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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