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Treatment of Nicotine Dependence and Acute Depression

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Stanford University

Status and phase

Completed
Phase 4

Conditions

Major Depressive Disorder
Nicotine Dependence

Treatments

Drug: bupropion and smoking cessation behavioral intervention

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00186446
GSK 103341

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Bupropion
Experimental group
Treatment:
Drug: bupropion and smoking cessation behavioral intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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