VIVITROL as a Treatment for Cocaine and Alcohol Dependence
Condition: Cocaine Dependence; Alcohol Dependence
MeSH terms: Alcoholism; Cocaine-Related Disorders
Intervention: VIVITROL (Naltrexone extended-release injectable suspension); Placebo
Intervention description: VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6.; Placebo injection at the start of weeks 2 and 6.
Intervention MeSH terms: Naltrexone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: alcohol; cocaine; addiction; alcoholism; substance dependence; substance abuse

Summary:

      To evaluate the efficacy of VIVITROL (naltrexone for extended-release injectable suspension)
      for the treatment of co-occurring cocaine and alcohol dependence
    

Eligibility criteria:

        Inclusion Criteria

          1. Males and females, 18 to 65 years old.

          2. Meets DSM-IV criteria for Cocaine Dependence, as determined by the Structured Clinical
             Interview for DSM-IV (SCID).

          3. Meets DSM-IV criteria for Alcohol Dependence, as determined by the Structured Clinical
             Interview for DSM-IV (SCID).

          4. Meets the following drinking criteria as measured by the Timeline Followback (TLFB)
             (Sobell, 1995)

               1. drank within 30 days of intake day,

               2. reports a minimum of XX standard alcoholic drinks in a consecutive 30-day period
                  over the 90-day period prior to starting intake, and

               3. has 2 or more days of heavy drinking

          5. In the past 30 days prior to consent, used no less than $ of cocaine.

          6. 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.

          7. Understands and signs the informed consent.

          8. 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:

          1. 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.

          2. Concomitant treatment with psychotropic medications, including opioid analgesics.

          3. Patients mandated to treatment based upon a legal decision or as a condition of
             employment.

          4. 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).

          5. Taken any investigational medication within the past 30 days.

          6. 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] <3 x ULN are acceptable).

          7. Known hypersensitivity to naltrexone, PLG, carboxymethylcellulose, or any other
             components of the diluent.

          8. Subjects with a BMI of 40 and above, as determined by the Body Mass Index Table, or
             that have distribution of adipose tissue such that they would be at greater risk of
             serious injection site reaction, based on clinical judgment. Participants with a BMI
             over 30 will have additional screening procedures conducted to determine inclusion in
             the study. These procedures include an additional screening measurement of waist-hip
             ratio for those participants with a BMI over 30. Males with a waist to hip ratio of
             >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.

          9. Patients with any serious illnesses that may require hospitalization during the study.

         10. 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:

         11. Clinical laboratory tests (CBC, blood chemistries, urinalysis) outside normal limits
             that are clinically unacceptable to the Principal Investigator.

         12. Current physiological opioid dependence.

         13. Experiencing acute opiate withdrawal.

         14. Likely to receive scheduled surgery, which may require treatment with opioid
             analgesics.