Treatment of Nicotine Dependence and Acute Depression

Study Overview
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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.

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.

Official Title
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Treatment of Nicotine Dependence and Acute Depression

Conditions
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Major Depressive Disorder, Nicotine Dependence

Intervention / Treatment
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* Drug: bupropion and smoking cessation behavioral intervention


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupropion<br> | Drug: bupropion and smoking cessation behavioral intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Scale Score | Utilized the Hamilton Depression Rating Scale, 21-item version to assess depressive symptoms, with a range of 0-63. Higher values indicate more depression. % Change in depression score from baseline to week 10. Negative values indicate a reduction in depression. | baseline to week 10 | 
| Cessation of Smoking | Carbon monoxide breath level of below 9PPM which indicates cessation of smoking. | Week 10 | 
| Can Depression and Smoking Cessation be Treated Simultaneously | This was measured by the drop out rate during the study. | Dropouts over course of study |