Varenicline Effects In Schizophrenic Smokers

NCT00548470 | Completed Phase 4 Results

• 1 other identifier: 06I/C34-0
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Schizophrenia; Tobacco Use Disorder; Nicotine Dependance

Keywords

schizophrenia; varenicline; cognition; cigarette smoking

Outcome Measures

Primary Outcomes (3)

• Self Report of Smoking

  Patients self-report of smoking cigarettes. Patients were interviewed weekly about the number of cigarettes smoked. Number of cigarettes smoked in the past week.

  Baseline and during 2 months of treatment

• CO (Carbon Monoxide) Breathalyzer Level

  Carbon Monoxide in breath ,parts per million

  baseline and during 2 months of treatment

• Plasma Cotinine

  cotinine level in plasma ng/ml.

  baseline 1 month and 2 months

Secondary Outcomes (2)

• RBANS Neuropsychological Battery

  baseline and month 2 of treatment

• Change From Baseline in Psychiatric Symptoms

  Baseline and 2 months later

Study Arms (1)

varenicline

EXPERIMENTAL

open label varenicline 2mg/day

Drug: Varenicline

Interventions

Varenicline DRUG

Varenicline 1-2 mg/day

Also known as: Chantix

varenicline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Nathan Kline Institute for Psychiatric Research: lead
• University of Illinois at Chicago: collaborator

Study Sites (1)

Manhattan Psychiatric Center

New York, New York, 10035, United States

Location

Related Publications (1)

• Smith RC, Lindenmayer JP, Davis JM, Cornwell J, Noth K, Gupta S, Sershen H, Lajtha A. Cognitive and antismoking effects of varenicline in patients with schizophrenia or schizoaffective disorder. Schizophr Res. 2009 May;110(1-3):149-55. doi: 10.1016/j.schres.2009.02.001. Epub 2009 Feb 28.

  PMID: 19251401 RESULT

MeSH Terms

Conditions

Schizophrenia; Tobacco Use Disorder; Cigarette Smoking

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Robert C Smith MD
• Organization: Nathan Kline Institute for psychaitric Research

rsmith@nki.rfmh.org

845-398-6531

Study Officials

• Robert C Smith, MD, PhD

  Nathan Kline Institute of Psychiatric Research; NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychiatrist, Prinicipal Investigator

Study Record Dates

• First Submitted: October 22, 2007
• First Posted: October 24, 2007
• Study Start: June 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: December 1, 2010
• Last Updated: September 20, 2018
• Results First Posted: September 5, 2017

Record last verified: 2017-10

Locations

US (1)