Treatment of Nicotine Dependence and Acute Depression

Stanford University20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Major Depressive Disorder Nicotine Dependence

Interventions

bupropion and smoking cessation behavioral interventionDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford University School of Medicine

Stanford, California, United States

Outcomes

Primary Outcomes

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.

Time frame: baseline to week 10

Cessation of Smoking

Carbon monoxide breath level of below 9PPM which indicates cessation of smoking.

Time frame: Week 10

Can Depression and Smoking Cessation be Treated Simultaneously

This was measured by the drop out rate during the study.

Time frame: Dropouts over course of study

Data from ClinicalTrials.gov

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