Alcoholism Clinical Trial
Official title:
Naltrexone and Psychosocial Treatments for the Treatment of Cocaine Dependence Complicated by Alcohol Dependence
The purpose of this study is to see whether naltrexone is safe and useful in preventing
alcohol relapse, as well as in decreasing craving for alcohol in people with a diagnosis of
alcohol and cocaine dependence. Naltrexone is approved by the Food and Drug Administration
(FDA) for the treatment of alcohol dependence. However, the medication was not approved as
yet at the dosage we will use in this study. The dosage we will use for the study (150 mg),
is greater than the recommended dosage from the Physician's Desk Reference (50mg). Unlike
other medicines (like Antabuse) useful in the treatment of alcohol dependence, naltrexone
will not make you sick if you drink alcohol. Rather, people who are taking this medication
have reported that it helps decrease the pleasure associated with drinking for them. This
study is being conducted because the medication (Naltrexone) has not been well studied in
people with both alcohol and cocaine dependence, so it is still investigational.
We believe that if we can reduce alcohol consumption through naltrexone and psychotherapy,
this may lead to reduced cocaine use. We are also conducting this study to test two different
types of psychotherapy as a method for reducing cocaine and alcohol use. One type of
psychotherapy is designed to help people learn to cope with situations that put them at high
risk for relapse to cocaine and/or alcohol use. The other type of psychotherapy we will use
focuses on strengthening motivation to recover from cocaine and/or alcohol use, and on
developing techniques to handle possible barriers to recovery. We seek to enroll 300 patients
in the study.
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