A Pilot Study of the Neural Correlates of Treatment Effec... | NCT00208858

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

NCT00208858

Sponsor

Emory University

Status

Completed

Last Update Posted

Jun 16, 2014Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Tobacco Use Disorder

Interventions

Topiramate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
DA00366-02	Other Identifier	Other
TPN-100	Other Identifier	Other

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2004

Primary Completion Date

Dec 2006Actual

Completion Date

Dec 2006Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2014

Last Update Posted Date

Jun 16, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Karen Drexler, Asc Professor/Director, Substance Abuse Treatment, Emory UniversityPrincipal Investigator

Lead Sponsor

Emory UniversityOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Topiramate	Drug

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karen Drexler, MD	Emory University, Atlanta VA Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Atlanta VA Medical Center		Decatur	Georgia	30033	United States

Condition Browse Module

MeSH Terms

ID	Term
D014029	Tobacco Use Disorder

Ancestor Terms

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077236	Topiramate

Ancestor Terms

ID	Term
D005632	Fructose
D006601	Hexoses
D009005	Monosaccharides
D000073893	Sugars
D002241

Browse Leaves

Not provided

Browse Branches

Not provided