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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2006 by Emory University.
Recruitment status was  Recruiting
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
First received: September 13, 2005
Last updated: July 13, 2006
Last verified: July 2006

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-Blind
Official Title: Nicotine Craving: Neural Correlates of Treatment Effect - A Pilot Study

Resource links provided by NLM:

Further study details as provided by Emory University:


Ages Eligible for Study:   18 Years to 55 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208858

Contact: Karen Drexler, MD 404-321-6111 karen.drexler@med.va.gov

United States, Georgia
Atlanta VA Medical Center Recruiting
Decatur, Georgia, United States, 30033
Contact: Karen Drexler, MD    404-321-6111    karen.drexler@med.va.gov   
Sponsors and Collaborators
Emory University
Principal Investigator: Karen Drexler, MD Emory University, Atlanta VA Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00208858     History of Changes
Other Study ID Numbers: TPN-100, DA00366-02
Study First Received: September 13, 2005
Last Updated: July 13, 2006
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
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 Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents
Anti-Obesity Agents

ClinicalTrials.gov processed this record on April 22, 2014