Treatment of Nicotine Dependence and Acute Depression

Phase 4

Completed

• Conditions: Major Depressive Disorder; Nicotine Dependence
• Interventions: Drug: bupropion and smoking cessation behavioral intervention

• Registration Number: NCT00186446
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Results First Submitted: 2016-10-18
• Status Verified: 2017-02
• Results First Submitted QC: 2017-02-15
• Last Update Submitted: 2017-02-15
• Results First Posted: 2017-04-04
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bupropion	bupropion and smoking cessation behavioral intervention	-

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Scale Score	baseline to week 10	Utilized the Hamilton Depression Rating Scale, 21-item version to assess depressive symptoms, with a range of 0-63. Higher values indicate more depression. % Change in depression score from baseline to week 10. Negative values indicate a reduction in depression.
Cessation of Smoking	Week 10	Carbon monoxide breath level of below 9PPM which indicates cessation of smoking.
Can Depression and Smoking Cessation be Treated Simultaneously	Dropouts over course of study	This was measured by the drop out rate during the study.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States