NCT00113737

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Feb 1998

Typical duration for not_applicable cardiovascular-diseases

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1998

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2002

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2005

Completed
Last Updated

February 18, 2016

Status Verified

June 1, 2005

First QC Date

June 9, 2005

Last Update Submit

February 17, 2016

Conditions

Cardiovascular DiseasesHeart Diseases

Interventions

fluoxetineDRUG
cognitive behavioral therapyBEHAVIORAL

Eligibility Criteria

AgeUp to 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
An estimated 144 smokers with a prior history of depression and 206 smokers who lacked such a history.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (10)

  • Hitsman B, Spring B, Wolf W, Pingitore R, Crayton JW, Hedeker D. Effects of acute tryptophan depletion on negative symptoms and smoking topography in nicotine-dependent schizophrenics and nonpsychiatric controls. Neuropsychopharmacology. 2005 Mar;30(3):640-8. doi: 10.1038/sj.npp.1300651.

    PMID: 15647750BACKGROUND

  • Sanchez-Johnsen LA, Fitzgibbon ML, Ahluwalia JS, Spring BJ. Eating pathology among Black and White smokers. Eat Behav. 2005 Feb;6(2):127-36. doi: 10.1016/j.eatbeh.2004.08.011.

    PMID: 15598599BACKGROUND

  • Holmes EW, Russell PM, Kinzler GJ, Reckard CR, Flanigan RC, Thompson KD, Bermes EW Jr. Oxidative tryptophan metabolism in renal allograft recipients: increased kynurenine synthesis is associated with inflammation and OKT3 therapy. Cytokine. 1992 May;4(3):205-13. doi: 10.1016/1043-4666(92)90057-x.

    PMID: 1498255BACKGROUND

  • Cook JW, Spring B, McChargue DE, Borrelli B, Hitsman B, Niaura R, Keuthen NJ, Kristeller J. Influence of fluoxetine on positive and negative affect in a clinic-based smoking cessation trial. Psychopharmacology (Berl). 2004 Apr;173(1-2):153-9. doi: 10.1007/s00213-003-1711-8. Epub 2004 Jan 15.

    PMID: 14727000BACKGROUND

  • Spring B, Pagoto S, McChargue D, Hedeker D, Werth J. Altered reward value of carbohydrate snacks for female smokers withdrawn from nicotine. Pharmacol Biochem Behav. 2003 Sep;76(2):351-60. doi: 10.1016/j.pbb.2003.08.008.

    PMID: 14592688BACKGROUND

  • Spring B, Pingitore R, McChargue DE. Reward value of cigarette smoking for comparably heavy smoking schizophrenic, depressed, and nonpatient smokers. Am J Psychiatry. 2003 Feb;160(2):316-22. doi: 10.1176/appi.ajp.160.2.316.

    PMID: 12562579BACKGROUND

  • Johnsen L, MacKirnan D, Spring B, Pingitore R, Sommerfeld BK. Smoking as subculture? Influence on Hispanic and non-Hispanic White women's attitudes toward smoking and obesity. Health Psychol. 2002 May;21(3):279-87. doi: 10.1037//0278-6133.21.3.279.

    PMID: 12027034BACKGROUND

  • Hitsman B, Spring B, Borrelli B, Niaura R, Papandonatos GD. Influence of antidepressant pharmacotherapy on behavioral treatment adherence and smoking cessation outcome in a combined treatment involving fluoxetine. Exp Clin Psychopharmacol. 2001 Nov;9(4):355-62. doi: 10.1037//1064-1297.9.4.355.

    PMID: 11764011BACKGROUND

  • Richmond M, Spring B, Sommerfeld BK, MeChargue D. Rumination and cigarette smoking: a bad combination for depressive outcomes? J Consult Clin Psychol. 2001 Oct;69(5):836-40. doi: 10.1037//0022-006x.69.5.836.

    PMID: 11680561BACKGROUND

  • Borrelli B, Spring B, Niaura R, Kristeller J, Ockene JK, Keuthen NJ. Weight suppression and weight rebound in ex-smokers treated with fluoxetine. J Consult Clin Psychol. 1999 Feb;67(1):124-31. doi: 10.1037//0022-006x.67.1.124.

    PMID: 10028216BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesHeart Diseases

Interventions

FluoxetineCognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Bonnie Spring

    U.S. Dept/Vets Affairs Med Ctr.

Study Design

Study Type
interventional
Phase
not applicable
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

June 9, 2005

First Posted

June 10, 2005

Study Start

February 1, 1998

Study Completion

January 1, 2002

Last Updated

February 18, 2016

Record last verified: 2005-06