|
Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers Clinical research trials and Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers. Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "F" Clinical Trials Conditions > Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers  Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers
Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers
For Condition: Smoking,Depression
Status: Recruiting
Sponsor(s): Department of Veterans Affairs Medical Research Service , Eli Lilly and Company
Synopsis: 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.
Details: The aim of this research is to examine whether adding antidepressant pharmacotherapy to behavioral cessation treatment improves the depression-prone smoker's ability to quit, while not undermining cessation for the smoker who lacks a history of depression, by randomizing smokers both with and without such a history to double-blind treatment with either 60 mg fluoxetine or placebo. The primary Depressive Episode Hypothesis states that the stress of quitting smoking and the biological challenge of nicotine withdrawal trigger a depressive episode in vulnerable individuals. To the extent that episode onset can be prevented by prophylactic administration of antidepressant pharmacotherapy, smokers with a history of depression will show significantly higher abstinence rates when treated with fluoxetine than placebo, whereas no drug effect will be evident for history negative smokers who lack the depressive diathesis. An alternative generalized withdrawal hypothesis construes post-cessation dysphoria as one general manifestation of a nicotine withdrawal syndrome that occurs independently of depressive vulnerability, and predicts that fluoxetine, as compared to placebo, will uniformly improve cessation outcomes, regardless of whether smokers possess the diathesis for depression. Over period of four years, the study hopes to randomize 120 smokers with a history of depression and 120 smokers who lack such a history to double-blind treatment with either 60 mg fluoxetine or placebo, while they undergo group cognitive behavioral treatment to quit smoking. To allow plasma drug levels to stabilize before quitting smoking, drug or placebo treatment begins 3 weeks before quitting smoking and continues for an additional 8 weeks following the quit date. Participants will be followed up monthly for 4 months after the end of treatment in order to assess the main study outcome; abstinence from smoking 6 months after the quit date.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: 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. Subjects may not enter the trial if they: (1) have taken monoamine oxidase inhibitors, antidepressants, anti-anxiety agents, lithium, tryptophan or phenothiazines within the past month; (2) are being treated for hypertension with guanethidine, reserpine, thiazide diuretics, beta blockers, or clonidine, (3) are taking Type IC antiarrhythmics (e.g., propafenone and flecanide) or a highly protein-bound drug (e.g., warfarin, digitoxin), (4) have a medically unstable condition or had a major health event in the past 6 months (e.g., myocardial infarct or major surgery); (5) have CBC values more than 10% outside the normal limits, or liver enzymes exceeding 40% of the upper limit of normal; (6) have a history of severe allergies, multiple adverse drug reactions or known allergy to fluoxetine; (7) are actively abusing alcohol or drugs or received inpatient treatment for substance abuse within the past year; (8) are using nicotine replacements; (9) are pregnant, lactating, or of childbearing potential (10) 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; (11) have a score greater than 14 on the 21-item Hamilton Depression Rating Scale or greater than 15 on the Beck Depression Inventory; (12) 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.
Total Enrollment:
Location and Contact Information:
Edward Hines Jr. VA Hospital *Recruiting*
Hines, Illinois, 60141
United States
Recruiting Bonnie Spring 708-343-7200
Additional Information:
Study ID Numbers: ADRD-011-97S;
Study Start Date: February 1998
Record last reviewed: June 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00018174
Other Smoking Studies:
1. Music Therapy to Ease Pain and Emotional Distress in Patients With Hematologic Cancer Who Are Undergoing High-Dose Therapy and Stem Cell Transplantation
2. Psychological Treatments for Scleroderma
3. Combination Chemotherapy Plus Fluoxetine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
4. Prevention of Suicide in the Elderly
5. Electroacupuncture for Major Depression
Related Studies:
Other Smoking Clinical Trials
Other Illinois Clinical Trials
Other Hines Clinical Trials
Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers
|
|
|
|
|
|
|
|
