Smoking Cessation Study for Patients With Schizophrenia or Schizoaffective Disorder

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00644969
First received: March 21, 2008
Last updated: March 23, 2011
Last verified: March 2011
  Purpose

Study will determine whether patients with schizophrenia or schizoaffective disorder can be helped to quit smoking safely while using varenicline and receiving smoking cessation counseling.


Condition Intervention Phase
Smoking Cessation
Drug: placebo
Drug: varenicline (CP-526,555)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Phase 3B 12-Week, Double -Blind, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Varenicline Tartrate (CP-526,555) 1 mg BID for Smoking Cessation in Subjects With Schizophrenia and Schizoaffective Disorder.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 30 days after last dose of study treatment or up to Week 16 ] [ Designated as safety issue: Yes ]
    AEs are any untoward medical occurrence in a clinical investigation participant administered a product or medical device. The event does not need to be causally related to the study treatment or usage. SAEs include any untoward medical occurrence that results in death, are life threatening, requires hospitalization or prolongation of hospitalization, results in disability or incapacity or are a congenital anomaly or birth defect in the offspring of a study participant. Lack of efficacy was to be reported as an AE when it was associated with an SAE.

  • Number of Participants With Psychiatric Adverse Events [ Time Frame: Baseline up to Week 24 ] [ Designated as safety issue: Yes ]
    Psychiatric Adverse Event symptoms included, but were not restricted to, depression, anxiety, hostility, perceptual / thinking disturbance, suicidal ideation, or suicidal behavior based on clinical judgment and use of the Positive and Negative Syndrome Scale and Columbia Classification Algorithm of Suicide assessments.

  • Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Total Score [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: Yes ]
    PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Total scores range from 30 to 210 with higher scores indicating more extreme symptoms.

  • Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Total Score [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: Yes ]
    PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Total scores range from 30 to 210 with higher scores indicating more extreme symptoms.

  • Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: Yes ]
    PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Positive symptoms (productive symptoms) associated with schizophrenia (delusions, conceptual disorganization, and hallucinatory behavior) are rated on a scale from 1 (absent) to 7 (extreme); total positive subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.

  • Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: Yes ]
    PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Positive symptoms (productive symptoms) associated with schizophrenia (delusions, conceptual disorganization, and hallucinatory behavior) are rated on a scale from 1 (absent) to 7 (extreme); total positive subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.

  • Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: Yes ]
    PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Negative symptoms (deficit features) associated with schizophrenia (blunted affect, emotional withdrawal, poor rapport, and passive / apathetic social withdrawal) are rated on a scale from 1 (absent) to 7 (extreme); total negative subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.

  • Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: Yes ]
    PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Negative symptoms (deficit features) associated with schizophrenia (blunted affect, emotional withdrawal, poor rapport, and passive / apathetic social withdrawal) are rated on a scale from 1 (absent) to 7 (extreme); total negative subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.

  • Change From Baseline to Week 12 in Simpson Angus Rating Scale (SARS) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: Yes ]
    10-item rating scale to assess the severity of extrapyramidal symptoms rated on a 5-point scale 0 (normal) to 4 (highest severity). Items measured are gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella tap, tremor, and salivation. Global score calculated by summing individual item scores and dividing by the total number of items; range is 0 to 40 with higher scores indicating greater severity.

  • Change From Baseline to Week 24 in Simpson Angus Rating Scale (SARS) [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: Yes ]
    10-item rating scale to assess the severity of extrapyramidal symptoms rated on a 5-point scale 0 (normal) to 4 (highest severity). Items measured are gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella tap, tremor, and salivation. Global score calculated by summing individual item scores and dividing by the total number of items; range is 0 to 40 with higher scores indicating greater severity.

  • Number of Participants With Suicidal Behavior and / or Ideation ("Yes" Response) on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Treatment Phase [ Time Frame: Week 1 to Week 12 (Treatment phase) ] [ Designated as safety issue: Yes ]
    C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a "yes" response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a "yes" response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent).

  • Number of Participants With Suicidal Behavior or Suicical Ideation ("Yes" Response ) on the Columbia Suicide-Severity Rating Scale (C-SSRS) During the Post Treatment Phase [ Time Frame: Week 13 to Week 24 (Post treatment phase) ] [ Designated as safety issue: Yes ]
    C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a "yes" response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a "yes" response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent).

  • Number of Participants With Shift From Baseline to Week 12 in Clinical Global Impressions Scale-Severity (CGI-S) Score [ Time Frame: Baseline (Bsl) to Week 12 ] [ Designated as safety issue: Yes ]
    CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states.

  • Number of Participants With Shift From Baseline to Week 24 in Clinical Global Impressions Scale-Severity (CGI-S) Score [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: Yes ]
    CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states.

  • Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 1 [ Time Frame: Baseline, Week 1 ] [ Designated as safety issue: Yes ]
    CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.

  • Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: Yes ]
    CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.

  • Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: Yes ]
    CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.


Secondary Outcome Measures:
  • Number of Participants With 7-day Point Prevalence of Non-smoking at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    7-day point prevalence of non-smoking measured as the number of participants who maintained complete abstinence from cigarette smoking or other nicotine use in the previous 7 days before the Week 12 visit and had an end-expiratory carbon monoxide (CO) measurement of ≤10 parts per million (ppm).

  • Number of Participants With 7-day Point Prevalence of Non-smoking at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    7-day point prevalence of non-smoking measured as the number of participants who maintained complete abstinence from cigarette smoking or other nicotine use in the previous 7 days before the Week 24 visit and had an end-expiratory carbon monoxide (CO) measurement of ≤10 parts per million (ppm).

  • Number of Participants With at Least a 50 Percent (%) Reduction From Baseline to Week 12 and Week 24 in the Number of Cigarettes Smoked Per Day [ Time Frame: Baseline, Week 12, Week 24 ] [ Designated as safety issue: No ]
    Measured as at least a 50% reduction from baseline in cigarettes smoked per day averaged over the past 7 days at Week 12 and Week 24.

  • Change From Baseline to Week 12 and Week 24 in the Number of Cigarettes Smoked Per Day [ Time Frame: Baseline, Week 12, Week 24 ] [ Designated as safety issue: No ]
    Measured as mean number of cigarettes smoked per day averaged over the past 7 days at Week 12 and Week 24.


Enrollment: 128
Study Start Date: May 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Arm
Randomization 2:1 treatment to placebo
Drug: placebo
Randomization 2:1 treatment to placebo
Active Comparator: Treatment Arm Drug: varenicline (CP-526,555)
One week of titration up to 1mg bid and 11 weeks of dosing at 1mg bid
Other Name: Chantix, Champix

Detailed Description:

This is a safety study.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis (using the SCID-I/P at screening visit) of schizophrenia or schizoaffective disorder and judged to be stable (without hospitalization or acute exacerbation and functioning in society) on psychiatric treatment for at least the past 6 month.
  • Current cigarette smokers (at least 15/day during the past year with no period of abstinence greater than 3 months in the past year) male or female, between the ages of 18 and 75 inclusive, who are motivated to stop smoking.
  • Score 7 or higher on the Contemplation Ladder at the Screening, Week -1, and Baseline Visits.

Exclusion Criteria:

  • PANSS score >70 at Screen or Baseline Visit.
  • Subjects hospitalized within the past six months due to suicidal ideation or suicidal behavior or subjects considered to have serious suicidal ideation or suicidal behavior within the past six moth.
  • Subjects having active suicidal ideation or behavior identified at Screen, Week -1, or Baseline Visit.
  • Subjects taking Bupropion.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644969

Locations
United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80045
United States, Connecticut
Pfizer Investigational Site
Farmington, Connecticut, United States, 06030
Pfizer Investigational Site
New Haven, Connecticut, United States, 06519
United States, Massachusetts
Pfizer Investigational Site
Worcester, Massachusetts, United States, 01655
United States, New Jersey
Pfizer Investigational Site
New Brunswick, New Jersey, United States, 08901
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27705
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45237
United States, Pennsylvania
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77040
Canada, Alberta
Pfizer Investigational Site
Edmonton, Alberta, Canada, T5K 2J5
Canada, Ontario
Pfizer Investigational Site
Mississauga, Ontario, Canada, L5M 4N4
Pfizer Investigational Site
Toronto, Ontario, Canada, M5T 1R8
Pfizer Investigational Site
Toronto, Ontario, Canada, M6J 1H4
Pfizer Investigational Site
Toronto, Ontario, Canada, M5S 2S1
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00644969     History of Changes
Other Study ID Numbers: A3051072
Study First Received: March 21, 2008
Results First Received: March 23, 2011
Last Updated: March 23, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Smoking
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Habits
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014