This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a single site, randomized, open-label study for the treatment of alcohol dependence comparing standard primary care with standard primary care complimented by the addition of the Prometa? Treatment Protocol. Patients meeting DSM IV criteria for alcohol dependence, and who have demonstrated understanding of the study's intent, risks and requirements, have signed informed consent, will be admitted to the study. The four-month protocol contains one month of medication treatment (i.e., for the 50% of study participants randomized to receive the Prometa? Treatment Protocol) followed by 3 months of follow-up. For the purposes of patient stabilization, establishment of a common baseline and initiation of study medication, the protocol begins with a 2-day inpatient stay. Following the brief inpatient stay, all study participants are to receive follow-up care by their primary care physician. The study participants randomized to receive the Prometa? Treatment Protocol will also receive study medication during the first month of primary care. Hypothesis # 1: When compared to patients receiving primary care alone, alcohol-dependent study participants randomized to receive primary care plus the Prometa? Treatment Protocol will have increased days of abstinence from alcohol, increased delay to time of first drink and decreased days of heavy drinking. Hypothesis # 2: Whether those study participants receiving the Prometa? Treatment Protocol will have a milder manifestation of alcohol withdrawal as well as a more rapid resolution of any alcohol withdrawal. Hypothesis # 3: Whether those study participants receiving the Prometa? Treatment Protocol will have a more rapid resolution of any baseline cognitive, anxiety, mood, hepatic or general health dysfunction demonstrable within the first few study days (all of these conditions being directly or indirectly caused by chronic alcohol use).
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