Status:
COMPLETED
New Treatment for Alcohol and Nicotine Dependence
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
M.D. Anderson Cancer Center
Conditions:
Alcohol Dependence
Nicotine Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 indiv...
Detailed Description
We propose a novel pharmacological strategy for treating alcohol and nicotine dependence concomitantly. The reinforcing effects of both alcohol and nicotine are mediated through the cortico-mesolimbi...
Eligibility Criteria
Inclusion
- 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
- Please contact site for additional information
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2017
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT01182766
Start Date
November 1 2011
End Date
October 6 2017
Last Update
October 31 2025
Active Locations (4)
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1
University of California, San Diego
La Jolla, California, United States, 92093
2
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
3
University of Virginia Center for Addiction Research & Education
Charlottesville, Virginia, United States, 22911
4
University of Virginia Center for Addiction Research & Education
Richmond, Virginia, United States, 23294