Treatment of Nicotine Dependence and Acute Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Stanford University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00186446
First received: September 13, 2005
Last updated: February 8, 2007
Last verified: February 2007
  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
Drug: nicotine patch
Behavioral: smoking cessation
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Nicotine Dependence and Acute Depression

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • We hope to learn whether or not it is safe to target both smoking cessation and acute depression concurrently, without adversely affecting treatment outcomes for either disorder.

Estimated Enrollment: 30
Study Start Date: June 2004
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
Genders Eligible for Study:   Both
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

No publications provided

ClinicalTrials.gov Identifier: NCT00186446     History of Changes
Other Study ID Numbers: GSK 103341
Study First Received: September 13, 2005
Last Updated: February 8, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depressive Disorder, Major
Depressive Disorder
Depression
Tobacco Use Disorder
Mood Disorders
Mental Disorders
Behavioral Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014