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

NCT00593099 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2017-01-11

No results posted yet for this study

Summary

The purpose of this pilot study is to determine the safety and potential efficacy of sustained-release bupropion (Zyban®) for the treatment of nicotine dependence in patients with bipolar affective illness. It is hypothesized that bupropion will produce a significant enhancement of smoking abstinence compared to placebo and will be safe for use in these patients.

Conditions

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.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    lead NIH

Principal Investigators

  • Tony P. George, M.D., FRCPC · University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2006-06-30
Completion
2006-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00593099 on ClinicalTrials.gov