Phase 3 N=128 Randomized Double-blind

Smoking Cessation Study for Patients With Schizophrenia or Schizoaffective Disorder

Smoking Cessation

Bottom Line

View on ClinicalTrials.gov: NCT00644969 ↗

Enrolled (actual)

128

Serious AEs

7.1%

Results posted

Apr 2011

Primary outcome: Primary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 5; 4; 70; 35 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: placebo (Drug); varenicline (CP-526,555) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Apr 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	5; 4; 70; 35	—
PRIMARY Number of Participants With Psychiatric Adverse Events	6; 4; 0; 1; 0; 1	—
PRIMARY Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Total Score	55.88; 54.47; -5.19; -3.46	—
PRIMARY Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Total Score	-4.77; -3.27	—
PRIMARY Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score	13.43; 13.53; -1.87; -1.33	—
PRIMARY Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score	-1.49; -1.68	—
PRIMARY Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score	14.75; 14.79; -1; -1.33	—
PRIMARY Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score	-1.43; -0.68	—
PRIMARY Change From Baseline to Week 12 in Simpson Angus Rating Scale (SARS)	1.452; 1.139; -0.42; 0.102	—
PRIMARY Change From Baseline to Week 24 in Simpson Angus Rating Scale (SARS)	-0.37; -0.29	—
PRIMARY Number of Participants With Suicidal Behavior and / or Ideation ("Yes" Response) on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Treatment Phase	9; 4	—
PRIMARY 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	6; 0	—
PRIMARY Number of Participants With Shift From Baseline to Week 12 in Clinical Global Impressions Scale-Severity (CGI-S) Score	1; 0; 1; 1; 1; 0	—
PRIMARY Number of Participants With Shift From Baseline to Week 24 in Clinical Global Impressions Scale-Severity (CGI-S) Score	1; 0; 1; 1; 1; 0	—
PRIMARY Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 1	0; 0; 3; 0; 4; 3	—
PRIMARY Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 12	1; 0; 1; 0; 5; 4	—
PRIMARY Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 24	2; 0; 2; 1; 8; 5	—
SECONDARY Number of Participants With 7-day Point Prevalence of Non-smoking at Week 12	16; 2	0.0457 sig
SECONDARY Number of Participants With 7-day Point Prevalence of Non-smoking at Week 24	10; 1	0.0901
SECONDARY 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	54; 22; 34; 18	0.1524
SECONDARY Change From Baseline to Week 12 and Week 24 in the Number of Cigarettes Smoked Per Day	-14.23; -10.58; -9.55; -9.32	0.0077 sig

Summary

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00644969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.