Treatment of Nicotine Dependence and Acute Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Stanford University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00186446
First received: September 13, 2005
Last updated: February 8, 2007
Last verified: February 2007

September 13, 2005
February 8, 2007
June 2004
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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.
Same as current
Complete list of historical versions of study NCT00186446 on ClinicalTrials.gov Archive Site
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Treatment of Nicotine Dependence and Acute Depression
Treatment of Nicotine Dependence and Acute Depression

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Major Depressive Disorder
  • Nicotine Dependence
  • Drug: bupropion
  • Drug: nicotine patch
  • Behavioral: smoking cessation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00186446
GSK 103341
Not Provided
Not Provided
Stanford University
GlaxoSmithKline
Study Director: Anna Lembke, MD Stanford University
Stanford University
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP