Who can join this study?
We are looking for healthy men, ages 35-70, who are regular drinkers and are interested in stopping or reducing their use of alcohol.
What is the purpose of this study?
The purpose of this study is to see whether the medication Dutasteride compared with an inactive placebo is safe and effective for reducing alcohol use.
Dutasteride is an FDA approved medication used to help men with enlarged prostate glands. Dutasteride affects the way certain hormones are processed in the body. Although Dutasteride is FDA approved for men with enlarged prostate glands, it is not FDA approved for the purpose of this study.
What is it like to participate?
- Phone screening: You will need to call for a brief phone interview. We will ask you about your medical and psychiatric history, and about past use of alcohol and drugs. This interview takes about 10 minutes and all information is kept in strict confidence. The study coordinator will then give your information to the principal investigator to determine whether this study might be appropriate for you.
- Screening visit: The screening visit is necessary to determine whether this study is appropriate for you. It will involve a series of interviews, blood samples for biochemical tests and to obtain DNA, a urine toxicology screening, and routine urinalysis. This visit will last approximately two and a half hours.
- Based on the results of the screening visit you may or may not be invited back to participate in the baseline visit which is the first visit in the treatment phase of this study.
- Baseline visit: During this visit you will receive a physical examination by the study doctor. You will also receive the study medication or placebo and instructions on how to take it. This visit will last approximately two hours.
- Treatment phase: The treatment phase includes two 12-week blocks. During the first block you will receive either Dutasteride or placebo. During the second 12-week block you will continue your block one medication if you reduced drinking or, if not, you will receive naltrexone, and FDA approved medication for reducing drinking for block 2.
- You will have biweekly study visits with the study nurse to receive supply of the study medication. Each visit will last about 30 minutes. At some of these study visits, you will be asked for blood and urine samples for laboratory testing.
- During part of the treatment phase, you will be asked to call daily into an interactive voice response system.
- There are 3- and 6-month follow-up visits after you have completed the 24 week treatment phase. These will last about 45 minutes. You will be asked to complete questionnaires and blood samples will be drawn for laboratory testing.
THANK YOU!
Your participation in the Dutasteride Alcohol Medication Treatment Study is greatly valued and appreciated.