- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00113737
Fluoxetine as a Quit Smoking AID for Depression Prone
Study Overview
Status
Conditions
Intervention / Treatment
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.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Masking: Double
Collaborators and Investigators
Investigators
- Bonnie Spring, U.S. Dept/Vets Affairs Med Ctr.
Publications and helpful links
General Publications
- 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.
- Spring B, Pagoto S, McChargue D, Hedeker D, Werth J. Altered reward value of carbohydrate snacks for female smokers withdrawn from nicotine.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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Fluoxetine
Other Study ID Numbers
- 183
- R01HL059348 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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