Fluoxetine as a Quit Smoking AID for Depression Prone

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00113737
First received: June 9, 2005
Last updated: June 23, 2005
Last verified: June 2005
  Purpose

To test whether adding fluoxetine pharmacotherapy to behavioral cessation treatment improves the depression-prone smoker’s ability to quit.


Condition Intervention
Cardiovascular Diseases
Heart Diseases
Drug: fluoxetine
Behavioral: cognitive behavioral therapy

Study Type: Interventional
Study Design: Masking: Double-Blind
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: February 1998
Estimated Study Completion Date: January 2002
Detailed Description:

DESIGN NARRATIVE:

The research was a treatment-matching study to test whether adding fluoxetine pharmacotherapy to behavioral cessation treatment improved the depression-prone smoker's ability to quit. The investigators randomized 144 smokers with a prior history of depression and 206 smokers who lack such a history to a double-blind treatment with either 60 mg fluoxetine or placebo, while they underwent cognitive behavioral treatment to quit smoking. The main study outcome was biologically verified abstinence 6 months after treatment. The administration of placebo and fluoxetine began 3 weeks before the quit smoke date and continued for 2 months post-quit date (totaling 11 weeks on drug/placebo). Cognitive behavioral treatment were weekly before quitting and biweekly after quitting. There were monthly follow-up evaluations for six months after the quit date. The research tested both the Selective Benefit Hypothesis and the Generalized Benefit Hypothesis of fluoxetine's effects. The hypothesis of the mechanism of action was that the drug diminished compulsive smoking behavior, obsessional cigarette craving, and nicotine withdrawal dysphoria that occurred independently of depressive vulnerability.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

An estimated 144 smokers with a prior history of depression and 206 smokers who lacked such a history.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00113737

Sponsors and Collaborators
Investigators
Investigator: Bonnie Spring U.S. Dept/Vets Affairs Med Ctr.
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00113737     History of Changes
Other Study ID Numbers: 183
Study First Received: June 9, 2005
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014