Back to resultsTreatment of Nicotine Dependence and Acute Depression
Primary Purpose
Major Depressive Disorder, Nicotine Dependence
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
bupropion and smoking cessation behavioral intervention
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
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
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bupropion
Arm Description
Outcomes
Primary Outcome Measures
Hamilton Depression Scale Score
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
Carbon monoxide breath level of below 9PPM which indicates cessation of smoking.
Can Depression and Smoking Cessation be Treated Simultaneously
This was measured by the drop out rate during the study.
Secondary Outcome Measures
Full Information
NCT ID
NCT00186446
First Posted
September 13, 2005
Last Updated
February 15, 2017
Sponsor
Stanford University
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00186446
Brief Title
Treatment of Nicotine Dependence and Acute Depression
Official Title
Treatment of Nicotine Dependence and Acute Depression
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Nicotine Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bupropion
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
bupropion and smoking cessation behavioral intervention
Primary Outcome Measure Information:
Title
Hamilton Depression Scale Score
Description
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.
Time Frame
baseline to week 10
Title
Cessation of Smoking
Description
Carbon monoxide breath level of below 9PPM which indicates cessation of smoking.
Time Frame
Week 10
Title
Can Depression and Smoking Cessation be Treated Simultaneously
Description
This was measured by the drop out rate during the study.
Time Frame
Dropouts over course of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Lembke, MD
Organizational Affiliation
Stanford University
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment of Nicotine Dependence and Acute Depression
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