Varenicline Treatment for Smoking Cessation in Patients With Bipolar Disorder

PHASE4CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 31, 2010

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2013

Conditions
Smoking CessationBipolar Disorder
Interventions
DRUG

Varenicline

Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.

DRUG

Placebo

Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.

Trial Locations (2)

15213

Western Psychiatric Institute and Clinic, Pittsburgh

15801

Dubois Regional Medical Center, DuBois

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

collaborator

Pfizer

INDUSTRY

lead

K.N. Roy Chengappa

OTHER