Overview

This trial is active, not recruiting.

Conditions major depressive disorder, nicotine dependence
Treatments bupropion, nicotine patch, smoking cessation
Phase phase 4
Sponsor Stanford University
Collaborator GlaxoSmithKline
Start date June 2004
Trial size 30 participants
Trial identifier NCT00186446, GSK 103341

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
We hope to learn whether or not it is safe to target both smoking cessation and acute depression concurrently, without adversely affecting treatment outcomes for either disorder.
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Treatment of Nicotine Dependence and Acute Depression
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2007.
Information provided to ClinicalTrials.gov by Stanford University.