A Preliminary Study of Sustained-Release Bupropion for Smoking Cessation in Bipolar Affective Disorder

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

April 30, 2004

Primary Completion Date

June 30, 2006

Study Completion Date

June 30, 2006

Conditions
Bipolar Disorder
Interventions
DRUG

Bupropion

BUP \[as the intermediate-release (IR) formulation\] was inducted on Day 1 of the trial at 75 mg po qd x 3 days, then increased to 150 mg \[as BUP SR formulation\] qd x 4 days, and then increased to a final dose of up to 150 mg po bid (300 mg/day) by Day 15 (target quit date; TQD) as tolerated. This dose was continued for an additional eight (8) weeks at up to 150 mg po bid. Flexible dosing was permitted to allow for adjustments needed if a bipolar subject did not tolerate the full dose of BUP at 300 mg/day. BUP was discontinued at the end of Week 10.

DRUG

Placebo

matching placebo capsules (PLA) containing only a dextrose matrix.

Trial Locations (1)

06519

Connecticut Mental Health Center, New Haven

All Listed Sponsors
lead

National Institute on Drug Abuse (NIDA)

NIH

NCT00593099 - A Preliminary Study of Sustained-Release Bupropion for Smoking Cessation in Bipolar Affective Disorder | Biotech Hunter | Biotech Hunter