Treatment of Nicotine Dependence and Acute Depression

Major Depressive Disorder Clinical Trial

Official title:

Treatment of Nicotine Dependence and Acute Depression

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00186446
• Other study ID #: GSK 103341
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: February 8, 2007
• Start date: June 2004

Study information

• Verified date: February 2007
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Drug:
• bupropion

• nicotine patch

Behavioral:
• smoking cessation

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.