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
Recruitment status was Active, not recruiting
Sponsor:
Stanford University
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
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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:
Drug Information available for:
Nicotine tartrate
Bupropion hydrochloride
Bupropion
Nicotine polacrilex
U.S. FDA Resources
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 |
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
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:
|
Depression Depressive Disorder Tobacco Use Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Substance-Related Disorders Nicotine Nicotine polacrilex Bupropion 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 Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Uptake Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013