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A Pilot Study of the Neural Correlates of Treatment Effect on Nicotine Craving

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00208858
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : June 16, 2014
Information provided by (Responsible Party):
Karen Drexler, Emory University

Brief Summary:
The purpose of this study is to gather pilot data to determine feasibility of and guide the development of a larger clinical trial investigating the effects of topiramate as an adjunct to nicotine replacement therapy and behavioral counseling in smoking cessation treatment. It is hypothesized that topiramate will decrease nicotine craving and result in improved outcomes for smoking cessation.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Drug: Topiramate Phase 2

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Nicotine Craving: Neural Correlates of Treatment Effect - A Pilot Study
Study Start Date : December 2004
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Topiramate

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male

Inclusion Criteria:

  • Male, between ages of 18-55
  • Meets DSM-IV criteria for nicotine dependence
  • Smoke at least 20 cigarettes per day
  • Motivated to quit smoking

Exclusion Criteria:

  • Serious or unstable medical conditions
  • Current psychiatric disorder requiring medication or treatment
  • Taking medication that create risk of interaction with study drug
  • Current participation in another smoking cessation treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00208858

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United States, Georgia
Atlanta VA Medical Center
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
Emory University
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Principal Investigator: Karen Drexler, MD Emory University, Atlanta VA Medical Center

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Responsible Party: Karen Drexler, Asc Professor/Director, Substance Abuse Treatment, Emory University Identifier: NCT00208858    
Other Study ID Numbers: 0624-2004
DA00366-02 ( Other Identifier: Other )
TPN-100 ( Other Identifier: Other )
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: June 16, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
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
Hypoglycemic Agents