New Treatment for Alcohol and Nicotine Dependence

Summary

This research study aims to test whether topiramate (a drug that is being used for seizure) will help individuals who have problems with both alcohol and nicotine. The investigators believe that individuals taking topiramate will be more successful at abstaining from both alcohol and nicotine than individuals taking placebo.

Conditions

• Alcohol Dependence
• Nicotine Dependence

Interventions

DRUG

Low-Dose Topiramate

Low-dose topiramate (up to 125 mg/day) with brief behavioral enhancement therapy

DRUG

Placebo

Placebo with brief behavioral enhancement therapy

DRUG

High-Dose Topiramate

High-dose topiramate (up to 250 mg/day) with brief behavioral enhancement therapy

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• M.D. Anderson Cancer Center

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• University of Virginia

  lead OTHER

Principal Investigators

• Nassima Ait-Daoud Tiouririne, MD · University of Virginia

• Robert M Anthenelli, MD · University of California, San Diego

• Paul M Cinciripini, PHD · M.D. Anderson Cancer Center

• Bankole A Johnson, MD · University of Virginia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-11-01

Primary Completion

2017-10-06

Completion

2017-10-06

FDA Drug

Yes

Countries

• United States

Study Locations