Safety and Effectiveness of Sustained Release Bupropion in Treating Individuals With Schizophrenia Who Smoke

PHASE4CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

August 31, 1998

Primary Completion Date

February 29, 2004

Study Completion Date

February 29, 2004

Conditions
Tobacco-Use DisorderSchizophreniaPsychotic Disorders
Interventions
DRUG

bupropion SR

Participants were randomly assigned to receive bupropion SR 150 mg or placebo, once daily for 7 days, then twice daily for 11 weeks.

BEHAVIORAL

Cognitive Behavioral Group Therapy

Participants attended a 12-session, 1-hour, weekly smoking cessation group program with 3 to 7 participants led by a psychologist with tobacco treatment specialist training. Subjects set a quit date, and nicotine patches (Habitrol) and nicotine polacrilex gum (Nicorette) were initiated in the fourth week.

DRUG

nicotine replacement therapy

Nicotine patch was dosed at 21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks, then discontinued. Nicotine gum (2 mg) was distributed for use as needed for craving up to 18 mg/d.

Trial Locations (1)

02114

Freedom Trail Clinic, Boston

All Listed Sponsors
lead

National Institute on Drug Abuse (NIDA)

NIH

NCT00307203 - Safety and Effectiveness of Sustained Release Bupropion in Treating Individuals With Schizophrenia Who Smoke | Biotech Hunter | Biotech Hunter