Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers

NCT00018174 | Completed Phase 3

• 1 other identifier: ADRD-011-97S
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 1

Brief 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

Depression; Smoking

Keywords

Depression; Fluoxetine; Nicotine dependence

Outcome Measures

Primary Outcomes (1)

• tobacco abstinence

  6 months

Study Arms (2)

1

EXPERIMENTAL

Drug: Fluoxetine; Behavioral: Behavioral group smoking cessation treatment

2

PLACEBO COMPARATOR

Behavioral: Behavioral group smoking cessation treatment; Drug: Placebo

Interventions

Fluoxetine DRUG

1

Behavioral group smoking cessation treatment BEHAVIORAL

1; 2

Placebo DRUG

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects may not enter the trial if they:
• have taken monoamine oxidase inhibitors, antidepressants, anti-anxiety agents, lithium, tryptophan or phenothiazines within the past month;
• are being treated for hypertension with guanethidine, reserpine, thiazide diuretics, beta blockers, or clonidine;
• are taking Type IC antiarrhythmics (e.g., propafenone and flecanide) or a highly protein-bound drug (e.g., warfarin, digitoxin);
• have a medically unstable condition or had a major health event in the past 6 months (e.g., myocardial infarct or major surgery);
• have CBC values more than 10% outside the normal limits, or liver enzymes exceeding 40% of the upper limit of normal;
• have a history of severe allergies, multiple adverse drug reactions or known allergy to fluoxetine;
• are actively abusing alcohol or drugs or received inpatient treatment for substance abuse within the past year;
• are using nicotine replacements;
• are pregnant, lactating, or of childbearing potential;
• 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;
• have a score greater than 14 on the 21-item Hamilton Depression Rating Scale or greater than 15 on the Beck Depression Inventory;
• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Edward Hines, Jr. VA Hospital

Hines, Illinois, 60141-3030, United States

Location

Related Publications (2)

• Spring B, Doran N, Pagoto S, McChargue D, Cook JW, Bailey K, Crayton J, Hedeker D. Fluoxetine, smoking, and history of major depression: A randomized controlled trial. J Consult Clin Psychol. 2007 Feb;75(1):85-94. doi: 10.1037/0022-006X.75.1.85.

  PMID: 17295567 RESULT

• Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.

  PMID: 37230961 DERIVED

MeSH Terms

Conditions

Depression; Smoking; Tobacco Use Disorder

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• Bonnie Spring, PhD

  Edward Hines Jr. VA Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: FED

Study Record Dates

• First Submitted: July 3, 2001
• First Posted: July 5, 2001
• Study Start: February 1, 1998
• Primary Completion: January 1, 2003
• Study Completion: January 1, 2005
• Last Updated: March 2, 2009

Record last verified: 2009-02

Locations

US (1)