Smoking Cessation Study for Patients With Schizophrenia or Schizoaffective Disorder

Pfizer

Status and phase: Completed; Phase 3

Conditions: Smoking Cessation

Treatments: Drug: varenicline (CP-526,555); Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00644969

A3051072

Details and patient eligibility

About

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.

Full description

This is a safety study.

Enrollment: 128 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

128 participants in 2 patient groups, including a placebo group

Placebo Arm

Placebo Comparator group

Description:

Randomization 2:1 treatment to placebo

Treatment:

Drug: placebo

Treatment Arm

Active Comparator group

Treatment:

Drug: varenicline (CP-526,555)