Treatment of Nicotine Dependence and Acute Depression

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