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NCT00208858 Clinical Trial

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

Tobacco Use Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00208858
Other study ID # 0624-2004
Secondary ID DA00366-02TPN-10
Status Completed
Phase Phase 2
First received September 13, 2005
Last updated June 13, 2014
Start date December 2004
Est. completion date December 2006

Study information
Verified date June 2014
Source Emory University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date December 2006
Est. primary completion date December 2006
Accepts healthy volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

Intervention

Drug:
• Topiramate

Locations
Country Name City State
United States Atlanta VA Medical Center Decatur Georgia

Sponsors (1)
Lead Sponsor Collaborator
Emory University

Country where clinical trial is conducted

United States, 

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