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Can a seizure drug help you quit drinking and smoking?

NCT ID NCT01182766

Disease control Sponsor: University of Virginia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether topiramate, a seizure medication, can help people who are dependent on both alcohol and nicotine. 236 adults received either a low or high dose of topiramate or a placebo, plus behavioral therapy. The goal was to see if the drug could reduce heavy drinking and help people quit smoking.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
topiramate (Topamax)
What this could lead to
If successful, this could point toward a treatment that helps people quit both alcohol and cigarettes at the same time.
What could go wrong
This trial is completed but results may not apply to everyone. Topiramate can cause side effects like dizziness and cognitive issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

236 people

The number who actually took part.

Started

Nov 2011

Finished

Oct 2017

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Males and females who have given written informed consent * Subjects must be above the age of 18 * Good physical health * Diagnostic and Statistical Manual (DSM)-IV diagnosis of mild to severe alcohol use disorder * Smoking ≥ 5 cigarettes/day * Currently drinking at least 8 standard drink units (SDUs) per week for women and at least 15 SDUs per week in the 30 days prior to randomization * Subjects must provide evidence of stable residence * The pregnancy test for females of child-bearing potential at screen and prior to randomization must be negative. Additionally, women of child-bearing potential must be using an acceptable form of contraception. * Literate in English and able to read, understand, and complete the rating scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments * Willing to participate in a treatment program for alcohol and nicotine dependence Exclusion Criteria: Please contact site for additional information

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Conditions

The condition(s) this trial relates to.

alcohol abuse alcohol dependence nicotine dependence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alcohol dependence Nicotine dependence

Contacts and locations

Locations

  • University of California, San Diego

    La Jolla, California, 92093, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Virginia Center for Addiction Research & Education

    Charlottesville, Virginia, 22911, United States

  • University of Virginia Center for Addiction Research & Education

    Richmond, Virginia, 23294, United States

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