Status:
COMPLETED
Treatment of Nicotine Dependence and Acute Depression
Lead Sponsor:
Stanford University
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Major Depressive Disorder
Nicotine Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 bot...
Detailed 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 bot...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00186446
Start Date
June 1 2004
End Date
September 1 2007
Last Update
April 4 2017
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305