Treatment of Nicotine Dependence and Acute Depression
Overview
- Phase
- Phase 4
- Intervention
- bupropion and smoking cessation behavioral intervention
- Conditions
- Major Depressive Disorder
- Sponsor
- Stanford University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Can Depression and Smoking Cessation be Treated Simultaneously
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Alan Schatzberg
Professor
Stanford University
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)
Arms & Interventions
Bupropion
Intervention: bupropion and smoking cessation behavioral intervention
Outcomes
Primary Outcomes
Can Depression and Smoking Cessation be Treated Simultaneously
Time Frame: Dropouts over course of study
This was measured by the drop out rate during the study.
Hamilton Depression Scale Score
Time Frame: 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
Time Frame: Week 10
Carbon monoxide breath level of below 9PPM which indicates cessation of smoking.