VIVITROL as a Treatment for Cocaine and Alcohol Dependence

Inclusion Criteria

• Males and females, 18 to 65 years old.
• Meets DSM-IV criteria for Cocaine Dependence, as determined by the Structured Clinical Interview for DSM-IV (SCID).
• Meets DSM-IV criteria for Alcohol Dependence, as determined by the Structured Clinical Interview for DSM-IV (SCID).
• Meets the following drinking criteria as measured by the Timeline Followback (TLFB) (Sobell, 1995)
• drank within 30 days of intake day,
• reports a minimum of XX standard alcoholic drinks in a consecutive 30-day period over the 90-day period prior to starting intake, and
• has 2 or more days of heavy drinking
• In the past 30 days prior to consent, used no less than $ of cocaine.
• Live within a commutable distance of the Treatment Research Center (TRC) at the Penn/VA Center for Studies of Addiction, University of Pennsylvania. We define this to be a distance within the service area of Septa, within an hour drive, or a distance that both the patient and Principal Investigator (PI) find acceptable.
• Understands and signs the informed consent.
• Three consecutive days of abstinence from alcohol, and a Clinical Institute Withdrawal Scale for Alcohol (CIWA-AR) (Sullivan, 1989) score below eight.

4.2 Exclusion Criteria:

• Positive urine drug screen and/or current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine, alcohol, or nicotine dependence, as determined by the SCID.
• Concomitant treatment with psychotropic medications, including opioid analgesics.
• Patients mandated to treatment based upon a legal decision or as a condition of employment.
• Current severe psychiatric symptoms, e.g., psychosis, dementia, suicidal or homicidal ideation, mania or depression requiring antidepressant therapy in the opinion of the Principal Investigator (PI).
• Taken any investigational medication within the past 30 days.
• History within the six months prior to randomization of significant heart disease (an arrhythmia which required medication, Wolff-Parkinson-White Syndrome, angina pectoris, documented history of myocardial infarction, heart failure). These are to be reviewed on a case-by-case basis: EKG 1st degree heart block, sinus tachycardia, left axis deviation, and nonspecific ST or T wave changes are allowed; liver function tests [LFTs] 0.9 and females with a waist to hip ratio of >0.85 will be referred to the investigator for final decision of study inclusion. If the ratio is <0.9 for men or <0.85 for women they will be eligible for study inclusion without further action.
• Patients with any serious illnesses that may require hospitalization during the study.
• Female subjects who are pregnant or lactating, or female subjects of child-bearing potential who are not using acceptable methods of birth control. Acceptable methods of birth control include:
• Clinical laboratory tests (CBC, blood chemistries, urinalysis) outside normal limits that are clinically unacceptable to the Principal Investigator.
• Current physiological opioid dependence.
• Experiencing acute opiate withdrawal.
• Likely to receive scheduled surgery, which may require treatment with opioid analgesics.