VIVITROL as a Treatment for Cocaine and Alcohol Dependence

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborators: Alkermes, Inc.; National Institute on Drug Abuse (NIDA)
• Treatments: Cocaine; Ethanol; Naltrexone

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.