Tobacco Use DisorderPhase 2NCT00208858
A Pilot Study of the Neural Correlates of Treatment Effect on Nicotine Craving
A Phase 2 study testing Topiramate in people with Tobacco Use Disorder, run by Emory University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Topiramate
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Dec 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Adult
Who may be able to join
- Male, between ages of 18-55
- Meets DSM-IV criteria for nicotine dependence
- Smoke at least 20 cigarettes per day
- Motivated to quit smoking
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nicotine Craving: Neural Correlates of Treatment Effect - A Pilot Study
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.
- Conditions
- Tobacco Use Disorder
- Being tested
- Topiramate
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopiramateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Drexler, Emory University
- Investigators
- Karen Drexler, MD, Principal investigator, Emory University, Atlanta VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00208858
- Sponsor's protocol ID
- 0624-2004
- Other IDs
- DA00366-02, TPN-100
- Status last verified
- Jun 2014
- First submitted
- 13 Sep 2005
- Last updated
- 16 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine Craving: Neural Correlates of Treatment Effect - A Pilot Study
- ClinicalTrials.gov ID
- NCT00208858
- Acronym / sponsor ID
- 0624-2004
- Conditions
- Tobacco Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male, between ages of 18-55
- Meets DSM-IV criteria for nicotine dependence
- Smoke at least 20 cigarettes per day
- Motivated to quit smoking
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topiramate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Drexler, MD principal investigator
Emory University, Atlanta VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topiramate in people with Tobacco Use Disorder, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2014.