Treatment of Nicotine Dependence and Acute Depression

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2007-09-30

Brief Summary

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The purpose of this study is to assess the safety and feasibility of concurrent treatment of nicotine dependence (cigarette smoking) and acute depression. Participants who meet DSM-IV criteria for both nicotine dependence and acute major depression will be given pharmacological treatment for both disorders at the same time, along with a brief behavioral intervention for smoking cessation.

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Detailed Description

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The purpose of this study is to assess the safety and feasibility of concurrent treatment of nicotine dependence (cigarette smoking) and acute depression. Participants who meet DSM-IV criteria for both nicotine dependence and acute major depression will be given pharmacological treatment for both disorders at the same time, along with a brief behavioral intervention for smoking cessation.

Conditions

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Major Depressive Disorder Nicotine Dependence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bupropion

Group Type EXPERIMENTAL

bupropion and smoking cessation behavioral intervention

Intervention Type DRUG

Interventions

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bupropion and smoking cessation behavioral intervention

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age at least 18 at the beginning of the study
* Smoking at least 10 cigarettes a day (1/2 pack)
* Meets DSM-IV criteria for major depressive episode

Exclusion Criteria

* Currently pregnant
* Currently breastfeeding
* Currently diagnosed with a seizure disorder, liver disease, kidney disease, congestive heart failure or diabetes mellitis
* History of a seizure, seizure disorder, significant head trauma or central nervous system tumor
* Family history of seizures
* Currently using intravenous drugs
* Currently using any drugs (marijuana, alcohol, cocaine, opiates, stimulants, etc.) on a daily basis
* Currently using any over-the-counter stimulants and anorectics (diet pills)
* Currently on fluoxetine (Prozac), bupropion (Wellbutrin, Wellbutrin SR, Wellbutrin XL) or any other antidepressants, monoamine oxidase inhibitors, antipsychotics, benzodiazepines, theophylline, systemic steroids or levodopa
* Currently on NRT or bupropion (Zyban)
* Current or past diagnosis of anorexia nervosa
* Previous allergic response to fluoxetine, bupropion, or NRT
* Previous failed quit attempt using NRT and bupropion in combination
* Current suicidal ideation
* Current or past psychosis, mania/hypomania, or any other Axis I or Axis II psychiatric diagnosis other than major depression and nicotine dependence

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No