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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karen Drexler, Emory University
ClinicalTrials.gov Identifier:
NCT00208858
First received: September 13, 2005
Last updated: June 13, 2014
Last verified: June 2014
  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-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:

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

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
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: 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

No publications provided

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, TPN-100
Study First Received: September 13, 2005
Last Updated: June 13, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014