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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2006-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Tobacco Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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Topiramate

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No