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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00208858
First Posted: September 21, 2005
Last Update Posted: June 16, 2014
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.
Information provided by (Responsible Party):
Karen Drexler, Emory University
  Purpose
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 Intervention Phase
Tobacco Use Disorder Drug: Topiramate Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Nicotine Craving: Neural Correlates of Treatment Effect - A Pilot Study

Resource links provided by NLM:


Further study details as provided by Karen Drexler, Emory University:

Study Start Date: December 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00208858


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

Responsible Party: Karen Drexler, Asc Professor/Director, Substance Abuse Treatment, Emory University
ClinicalTrials.gov Identifier: NCT00208858     History of Changes
Other Study ID Numbers: 0624-2004
DA00366-02 ( Other Identifier: Other )
TPN-100 ( Other Identifier: Other )
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: June 16, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Topiramate
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
Anticonvulsants
Neuroprotective Agents
Protective Agents
Anti-Obesity Agents