Status:
COMPLETED
Naltrexone in Two Models of Psychosocial Treatments for Cocaine and Alcohol Dependence
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Dependence
Alcoholism
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 ...
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 medical 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.
- Severe physical or medical illnesses such as AIDS, active hepatitis, significant hepatocellular injury as evidenced by elevated bilirubin levels, or elevated levels over 3.5x normal of aspartate aminotransferase (AST), and serum glutamic-pyruvic transaminase (SGPT).
- Current severe psychiatric symptoms, e.g., psychosis, suicidal or homicidal ideation or mania.
- 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 :
January 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2003
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT00167232
Start Date
January 1 1998
End Date
July 1 2003
Last Update
February 28 2018
Active Locations (1)
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1
University of Pennsylvania- Treatment Research Center
Philadelphia, Pennsylvania, United States, 19104