Understanding Treatment Response With Naltrexone Among White Alcoholics (DEFINE II)
Alcoholism
About this trial
This is an interventional treatment trial for Alcoholism
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Active Comparator
Placebo Comparator
Active Comparator
Group 1 Asn40 Placebo Placebo
Group 2 Asn40 Placebo Naltrexone
Group 3 Asp40 Placebo Placebo
Group 4 Asp40 Placebo Naltrexone
Each alcohol session preceded by pretreatment with placebo oral tablet
The first alcohol session preceded by pretreatment with placebo oral tablet. The second alcohol session preceded by pretreatment with naltrexone 50 mg as a single dose.
Each alcohol session preceded by pretreatment with placebo oral tablet
The first alcohol session preceded by pretreatment with placebo oral tablet. The second alcohol session preceded by pretreatment with naltrexone 50 mg as a single dose.