A 12-week study will be conducted with 150 outpatients with alcohol dependence, with random assignment to pregabalin 300 mg/day, duloxetine 40 mg/day, or placebo in conjuction with behavioral counseling and follow-up visits 1 week and 3 months post-treatment. Requires 2 screening visits. Weekly study visits (12) take approximately 1 hour to complete.
- Trial ID:
- Barbara J Mason, Ph.D.
- Be 18-65 years of age
- Abstain form alcohol at least 4 days, and up to 30 days
- Be willing to attend 12 weekly study visits and 2 follow-up visits, with no plans to move out of the greater San Diego area during this period
- Have medical disorders that could increase potential risk or interfere with study participation.
- Be sexually active females with childbearing potential who are pregnant, nursing or refuse to use reliable method of birth control.
- Be males who refuse to use a reliable form of birth control
- Be taking drugs that may increase potential risk or that may affect study outcomes.
- Be sent for treatment of alcoholism by a legal authority.
- The investigators are testing whether duloxetine and pregabalin might help people with an alcohol problem by normalizing their brain activity after they withdraw from alcohol and improving their mood and sleep.