Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms

NCT00578669 | Completed Phase 3 Results DMC

• 2 other identifiers: PHI0710-0021R01DA023190
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to determine whether, among smokers with elevated depressive symptoms, sequential antidepressant pharmacotherapy with fluoxetine (20 mg) begun 8 weeks prior to and extended throughout standard smoking cessation treatment with transdermal nicotine patch (ST-TNP) will result in superior short-and long-term smoking cessation outcomes compared to sequential pharmacotherapy with placebo medication combined with ST-TNP. The secondary aim of the study is to test the hypothesis that, among smokers with elevated depressive symptoms, sequential treatment with fluoxetine will result in lower levels of depressive symptoms and negative mood and higher levels of positive mood immediately prior to and throughout the course of smoking cessation treatment relative to the placebo condition.

Conditions

Major Depressive Disorder; Nicotine Dependence; Depression

Keywords

Smoking Cessation; Tobacco Use Cessation; Antidepressants

Outcome Measures

Primary Outcomes (1)

• Number of Participants Achieving Smoking Abstinence

  7-day point prevalence abstinence

  One year

Secondary Outcomes (1)

• Self-reported Depressive Symptoms

  One year

Study Arms (2)

1

ACTIVE COMPARATOR

Sequential antidepressant pharmacotherapy with (20mg) fluoxetine, begun 8 weeks prior to and extended throughout brief (behavioral) standard smoking cessation treatment with transdermal nicotine patch.

Drug: Fluoxetine

2

PLACEBO COMPARATOR

Sequential placebo medication (dextrose), begun 8 weeks prior to and extended throughout brief (behavioral) standard smoking cessation treatment with transdermal nicotine patch.

Drug: Dextrose

Interventions

Fluoxetine DRUG

20mg once daily for 16 weeks

Also known as: Prozac

1

Dextrose DRUG

Once daily for 16 weeks

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:

• Regular smoker for at least one year
• Currently smokes at least 10 cigarettes per day
• Elevated depressive symptoms
• Uses no other tobacco products

You may not qualify if:

• Current Axis I disorder, including Major Depressive Disorder
• Psychoactive substance abuse or dependence (excluding nicotine dependence) within past year
• Current use of psychotropic medication
• Use of antidepressant medication within past 6 months
• Current suicidal risk
• History of significant medical illness, such as cardiovascular disease, neurological, gastrointestinal, or other systemic illness
• Pregnancy or breast feeding
• Use of nicotine replacement therapy or of any medication for smoking cessation not provided by the researchers during the quit attempt

Sponsors & Collaborators

• Butler Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Related Links

• Website for Butler Hospital with links to research

MeSH Terms

Conditions

Depressive Disorder, Major; Tobacco Use Disorder; Depression; Smoking Cessation; Tobacco Use Cessation

Interventions

Fluoxetine; Glucose

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavioral Symptoms; Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Hexoses; Monosaccharides; Sugars; Carbohydrates

Results Point of Contact

• Title: Dr. Richard A. Brown
• Organization: UT Austin School of Nursing

brown2@utmail.utexas.edu

512-471-8584

Study Officials

• Richard A. Brown, Ph.D.

  Butler Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 21, 2007
• Study Start: April 1, 2008
• Primary Completion: July 1, 2013
• Study Completion: November 1, 2013
• Last Updated: October 16, 2018
• Results First Posted: October 16, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)