Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00018174
First received: July 3, 2001
Last updated: February 26, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Depression
Smoking
Drug: Fluoxetine
Behavioral: Behavioral group smoking cessation treatment
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • tobacco abstinence [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 247
Study Start Date: February 1998
Study Completion Date: January 2005
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Fluoxetine Behavioral: Behavioral group smoking cessation treatment
Placebo Comparator: 2 Behavioral: Behavioral group smoking cessation treatment Drug: Placebo

Detailed Description:

The aim of this research is to examine whether adding antidepressant pharmacotherapy to behavioral cessation treatment improves the depression-prone smoker's ability to quit, while not undermining cessation for the smoker who lacks a history of depression, by randomizing smokers both with and without such a history to double-blind treatment with either 60 mg fluoxetine or placebo. The primary Depressive Episode Hypothesis states that the stress of quitting smoking and the biological challenge of nicotine withdrawal trigger a depressive episode in vulnerable individuals. To the extent that episode onset can be prevented by prophylactic administration of antidepressant pharmacotherapy, smokers with a history of depression will show significantly higher abstinence rates when treated with fluoxetine than placebo, whereas no drug effect will be evident for history negative smokers who lack the depressive diathesis. An alternative generalized withdrawal hypothesis construes post-cessation dysphoria as one general manifestation of a nicotine withdrawal syndrome that occurs independently of depressive vulnerability, and predicts that fluoxetine, as compared to placebo, will uniformly improve cessation outcomes, regardless of whether smokers possess the diathesis for depression. Over period of four years, the study hopes to randomize 120 smokers with a history of depression and 120 smokers who lack such a history to double-blind treatment with either 60 mg fluoxetine or placebo, while they undergo group cognitive behavioral treatment to quit smoking. To allow plasma drug levels to stabilize before quitting smoking, drug or placebo treatment begins 3 weeks before quitting smoking and continues for an additional 8 weeks following the quit date. Participants will be followed up monthly for 4 months after the end of treatment in order to assess the main study outcome; abstinence from smoking 6 months after the quit date.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects will be 144 smokers who have experienced at least one episode of major depressive disorder and 206 smokers who lack a lifetime history of major depressive disorder.
  • None will currently meet diagnostic criteria for major depression, nor will they have met criteria in the past 6 months.
  • All will be male and female community members between the ages of 18 and 65 who have smoker at least 10 cigarettes a day for the past year.

Exclusion Criteria:

Subjects may not enter the trial if they:

  1. have taken monoamine oxidase inhibitors, antidepressants, anti-anxiety agents, lithium, tryptophan or phenothiazines within the past month;
  2. are being treated for hypertension with guanethidine, reserpine, thiazide diuretics, beta blockers, or clonidine;
  3. are taking Type IC antiarrhythmics (e.g., propafenone and flecanide) or a highly protein-bound drug (e.g., warfarin, digitoxin);
  4. have a medically unstable condition or had a major health event in the past 6 months (e.g., myocardial infarct or major surgery);
  5. have CBC values more than 10% outside the normal limits, or liver enzymes exceeding 40% of the upper limit of normal;
  6. have a history of severe allergies, multiple adverse drug reactions or known allergy to fluoxetine;
  7. are actively abusing alcohol or drugs or received inpatient treatment for substance abuse within the past year;
  8. are using nicotine replacements;
  9. are pregnant, lactating, or of childbearing potential;
  10. present current evidence of organic brain disease, definite or subclinical major depressive disorder or serious suicidal risk post-traumatic stress disorder, or premenstrual dysphoric disorder;
  11. have a score greater than 14 on the 21-item Hamilton Depression Rating Scale or greater than 15 on the Beck Depression Inventory;
  12. have a history of seizures, mania or hypomania, or psychosis. Individuals with bipolar disorder, PTSD, or schizophrenia will be excluded because they might respond adversely to fluoxetine.

Subjects with dysthymic disorder or anxiety disorders will be studied if their current symptoms are not sequelae of an episode of major depression. Excluding such cases would purify the sample by removing mild degrees of dysphoria, but would greatly restrict our ability to generalize any treatment implications to the current population that smokers.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00018174

Locations
United States, Illinois
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-3030
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Principal Investigator: Bonnie Spring, PhD Edward Hines Jr. VA Hospital
  More Information

Publications:
Responsible Party: Spring, Bonnie - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00018174     History of Changes
Other Study ID Numbers: ADRD-011-97S
Study First Received: July 3, 2001
Last Updated: February 26, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Depression
Fluoxetine
Nicotine dependence

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
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 September 18, 2014