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

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.

Completed

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Key information

Conditions

Tobacco Use Disorder Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topiramate

Drug

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Important dates

Study start: 2004
Primary completion: 2006
Study completion: 2006
First posted: Sep 21, 2005
Registry last updated: Jun 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed