NCT00208858

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

June 16, 2014

Status Verified

June 1, 2014

Enrollment Period

2 years

First QC Date

September 13, 2005

Last Update Submit

June 13, 2014

Conditions

Tobacco Use Disorder

Interventions

TopiramateDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Age GroupsAdult (18-64)

You may qualify if:

  • Male, between ages of 18-55
  • Meets DSM-IV criteria for nicotine dependence
  • Smoke at least 20 cigarettes per day
  • Motivated to quit smoking

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Karen Drexler, MD

    Emory University, Atlanta VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asc Professor/Director, Substance Abuse Treatment

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

December 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

June 16, 2014

Record last verified: 2014-06

Locations

US(1)