Fluoxetine as a Quit Smoking AID for Depression Prone
Information source: National Heart, Lung, and Blood Institute (NHLBI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiovascular Diseases; Heart Diseases
Intervention: fluoxetine (Drug); cognitive behavioral therapy (Behavioral)
Phase: N/A
Status: Completed
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI) Official(s) and/or principal investigator(s):
Bonnie Spring, Affiliation: U.S. Dept/Vets Affairs Med Ctr.
Summary
To test whether adding fluoxetine pharmacotherapy to behavioral cessation treatment improves
the depression-prone smokers ability to quit.
Clinical Details
Study design: Prevention, Double-Blind, Placebo Control
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
An estimated 144 smokers with a prior history of depression and 206 smokers who lacked such
a history.
Locations and Contacts
Additional Information
Related publications: 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. Sanchez-Johnsen LA, Fitzgibbon ML, Ahluwalia JS, Spring BJ. Eating pathology among Black and White smokers. Eat Behav. 2005 Feb;6(2):127-36. 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. 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. Epub 2004 Jan 15. 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. 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. 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. 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. 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. 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.
Starting date: February 1998
Ending date: January 2002
Last updated: June 23, 2005
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