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Clinical Trials/NCT00208858
NCT00208858CompletedPhase 2

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

Emory University1 site in 1 countryStarted: December 1, 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
Double

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
No

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Karen Drexler

Asc Professor/Director, Substance Abuse Treatment

Emory University

Study Sites (1)

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