Overview

Treatment of Nicotine Dependence and Acute Depression

Status:
Completed
Trial end date:
2007-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Stanford University
Collaborator:
GlaxoSmithKline
Treatments:
Bupropion
Nicotine
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