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Treatment of Nicotine Dependence and Acute Depression

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Alan Schatzberg, Stanford University
ClinicalTrials.gov Identifier:
NCT00186446
First received: September 13, 2005
Last updated: February 15, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention Phase
Major Depressive Disorder Nicotine Dependence Drug: bupropion and smoking cessation behavioral intervention Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Treatment of Nicotine Dependence and Acute Depression

Resource links provided by NLM:


Further study details as provided by Alan Schatzberg, Stanford University:

Primary Outcome Measures:
  • 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.

  • 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.


Enrollment: 20
Study Start Date: June 2004
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bupropion Drug: bupropion and smoking cessation behavioral intervention

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00186446

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
GlaxoSmithKline
Investigators
Study Director: Anna Lembke, MD Stanford University
  More Information

Responsible Party: Alan Schatzberg, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00186446     History of Changes
Other Study ID Numbers: GSK 103341
Study First Received: September 13, 2005
Results First Received: October 18, 2016
Last Updated: February 15, 2017

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Tobacco Use Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Nicotine
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 23, 2017