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Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers

NCT00018174 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 247

Last updated 2009-03-02

No results posted yet for this study

Summary

This project is a treatment-matching study to test whether adding antidepressant pharmacotherapy to behavioral cessation treatment improves the depression-prone smoker's ability to quit, while not undermining cessation goals for the smoker who lacks a history of depression. The study target is to randomize 120 smokers with a prior history of depression and 120 smokers who lack such a history to a double-blind treatment with either 60 mg fluoxetine or placebo, while they undergo cognitive behavioral treatment to quit smoking.

Conditions

Interventions

DRUG

Fluoxetine

BEHAVIORAL

Behavioral group smoking cessation treatment

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • Bonnie Spring, PhD · Edward Hines Jr. VA Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1998-02-28
Primary Completion
2003-01-31
Completion
2005-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT00018174 on ClinicalTrials.gov