Status:
COMPLETED
Naltrexone in Two Models of Psychosocial Treatments for Cocaine and Alcohol Dependence - 1
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Alcoholism
Cocaine Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
The project will use a 2x2 design to assess the efficacy of naltrexone for treating subjects who are both cocaine and alcohol dependent and who will receive either CBT or BRENDA alone or in combinatio...
Eligibility Criteria
Inclusion
- Male and females, 18-65 years old.
- Meets DSM-IV criteria for current diagnoses of cocaine and alcohol dependence, determined by the SCID.
- In the past 30 days, S used no less than $200-worth of cocaine and \>15 standard alcohol drinks (avg)/week with at least 1 day of 4 or more drinks, determined by the TLFB--adapted to collect daily cocaine use.
- Successful completion of alcohol detoxification, i.e.,
- 5 consecutive days of abstinence from cocaine and alcohol, via self-reports and negative urine toxicology screens.
- Lives a commutable distance to the TRC and agrees to follow-up visits.
- Understands and signs the consent.
Exclusion
- Abstinent from cocaine or alcohol for 30 days prior to signing consent form. (S may have been institutionalized in the prior month and still be eligible if his/her cocaine and alcohol use that month met inclusion criteria.)
- Current DSM-IV diagnosis of any substance dependence other than cocaine, alcohol, nicotine, or cannabis determined by the SCID.
- Evidence of opiate use in the past 30 days, determined by self-report on the SCID or ASI, and/or by a urine drug screen that is positive for opiates at treatment entry.
- Current treatment with psychotropic medications (excluding short-term use of benzodiazepines for detoxification), including disulfiram.
- History of unstable or serious medical illness, including need for opioid analgesics.
- History of epilepsy or seizure disorder.
- Known severe physical or medical illnesses such as AIDS, active hepatitis, significant hepatocellular injury as evidenced by elevated bilirubin levels, or elevated levels over 4.5x normal of aspartate aminotransferase (AST), and serum glutamic-pyruvic transaminase (SGPT).
- Current severe psychiatric symptoms, e.g., psychosis, dementia, acute suicidal or homicidal ideation, mania or depression requiring antidepressant therapy, or which would make it unsafe for the patient to participate in the opinion of the primary investigators.
- Use of an investigational medication in the past 30 days.
- Female Ss who are pregnant, nursing, or not using a reliable method of contraception. \[Note: Criteria 4-10 will be assessed via the medical exam plus results from lab tests.\]
Key Trial Info
Start Date :
April 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT00218660
Start Date
April 1 1998
End Date
November 1 2007
Last Update
October 22 2015
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104 6178