Clinical trial NCT00186446: Treatment of Nicotine Dependence and Acute Depression
Official title: Treatment of Nicotine Dependence and Acute Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Nicotine Dependence
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2005-09-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hamilton Depression Scale Score
timeFrame: baseline to week 10
measure: Cessation of Smoking
timeFrame: Week 10
measure: Can Depression and Smoking Cessation be Treated Simultaneously
timeFrame: Dropouts over course of study
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Anna Lembke, MD
role: STUDY_DIRECTOR
References: