Status:
COMPLETED
Understanding Treatment Response With Naltrexone Among White Alcoholics
Lead Sponsor:
University of Pennsylvania
Conditions:
Alcoholism
Eligibility:
MALE
21-64 years
Phase:
PHASE4
Brief Summary
This is a study involving treatment for alcohol dependence among males of European or Asian decent. The ultimate aim of this line of investigation is to further establish a genetic link between alcoho...
Detailed Description
Despite the well-established efficacy of naltrexone, there are significant variations in individual responses to naltrexone. A critical question remains: under what circumstances and for which patient...
Eligibility Criteria
Inclusion
- Males 21 years of age or older of European or Asian decent.
- Has a current DSM IV diagnosis of alcohol dependence as determined by the Structural Clinical Interview for DSM IV (SCID-IV Mini).
- Drank an average of 21 drinks/week in the 60 days prior to treatment and had at least 2 occasions of heavy drinking (5 or more drinks on a given day for men), as measured by the Timeline Followback (TLFB).
- Has adequate vision, hearing, and ability to communicate to allow study participation.
- Successfully completes detoxification as manifested by at least 48 consecutive hours of no self-reported alcohol use immediately prior to admission to the inpatient unit.
- Has signed a witnessed informed consent
- Scores below an 8 on the Clinical Inventory of Withdrawal for Alcohol (CIWA) prior to starting naltrexone/placebo; and 8) Can speak, print, and understand English.
Exclusion
- Meets DSM-IV criteria for dependence on any substance other than alcohol or nicotine in the last 6 months.
- Tests positive on the urine drug screen for opioids, cocaine, or amphetamine at the screening visit (only 1 repeat test permitted).
- Meets current or lifetime DSM-IV criteria for bipolar affective disorder, schizophrenia, or any psychotic disorder
- The presence of unstable or serious medical illness, including history of stroke, seizure disorder, severe liver disease (AST or ALT \> 5x normal at the time of randomization), or unstable cardiac disease
- Has taken any psychotropic medications (including disulfiram) regularly within the last seven days prior to randomization (14 days for fluoxetine) or needs immediate treatment with a psychotropic medication (with the exception of detoxification medications or benadryl used sparingly for sleep)
- Over age 64 and has evidence of severe cognitive impairment as evidenced by a Mini-mental status exam (MMSE) score \<24
- Has suicidal or homicidal ideation necessitating inpatient hospitalization
- Has been abstinent more than 14 days prior to Phase 1
- Is of African Descent
- Meets current DSM-IV criteria for for major depression (non-substance induced), PTSD, or panic disorder.
- Has significant hematological, pulmonary, endocrine, cardiovascular, renal, or gastrointestinal disease.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00817089
Start Date
December 1 2007
End Date
June 1 2010
Last Update
November 21 2019
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104