New Treatment for Alcohol and Nicotine Dependence

• Status: Active, not recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia
• Collaborators: M.D. Anderson Cancer Center; National Institute on Alcohol Abuse and Alcoholism (NIAAA); University of California, San Diego
• Treatments: Ethanol; Nicotine; Topiramate

Criteria

Inclusion Criteria:

• Males and females who have given written informed consent

• Subjects must be above the age of 18

• Good physical health

• 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:

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