Status:
COMPLETED
Pharmacogenetic Response to Naltrexone For Alcohol Dependence
Lead Sponsor:
David Oslin
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The aims of the study are to test for treatment outcome differences in alcohol dependent subjects randomly assigned to 12 weeks of treatment with NTX (50mg/day) or placebo among those with one or two ...
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
- Participant is male or female, 18 years of age or older, and of European or Asian descent.
- Participant has a current DSM-IV diagnosis of alcohol dependence using the SCID/MINI.
- The participant has signed a witnessed informed consent form.
- Participant meets the following drinking criteria as measured by the Timeline Follow Back (TLFB): a. Drinks at least an average of 21 drinks/wk in the 60-day period prior to intake and b. Has 2 or more days of heavy drinking (defined as 5 or more drinks per day in males, 4 or more in females) in this same pre-treatment period.
- Participant has at least 48 hours of abstinence, as determined by subject report and breathalyzer measure immediately prior to randomization.
- Participant scores below 8 on the Clinical Inventory of Withdrawal from Alcohol (CIWA) prior to starting Naltrexone.
- Participant has adequate vision, hearing and ability to communicate to allow study participation.
- Participant is able to speak, print and understand English.
Exclusion
- Participant meets DSM-IV criteria for dependence on any substance other than alcohol or nicotine in the last 6 months.
- Participant has tested positive on the urine drug screen for opioids, benzodiazepines, or cocaine at the screening visit. Presence of THC is allowable.
- Participant has a current or lifetime DSM-IV diagnosis of bipolar affective disorder, schizophrenia, or any psychotic disorder.
- Participant has presence of unstable or serious medical illness such as a recent stroke, idiopathic seizure disorder, or cardiac disease.
- Participant has severe liver disease (SGPT (ALT) or SGOT (AST) of at least 3 times normal value at the time of randomization or an elevated Total Bilirubin level without evidence of Gilbert's Syndrome.
- Participant has taken any psychotropic medications (including disulfiram) regularly within the last seven days (14 for fluoxetine) prior to randomization or needs immediate treatment with a psychotropic medication (antidepressant, antipsychotic, benzodiazepine, or mood stabilizing medication). EXCEPTIONS: Zolpidem and ramelteon used sparingly if necessary for sleep; Oxazepam for alcohol detoxification; Seizure disorder medications.
- Participant is over the age of 64 and has evidence of severe cognitive impairment as evidenced by a Mini-mental status exam (MMSE) score \< 24.
- Participant meets DSM-IV criteria for current major depression (non-substance induced), PTSD, or panic disorder.
- Participant has suicidal or homicidal ideation necessitating inpatient hospitalization.
- Participant is a pre-menopausal female who is pregnant, nursing, or not using a reliable method of contraception.
- Participant is over age 64 and has evidence of severe cognitive impairment as evidenced by a Mini-mental status exam (MMSE) score less than 20.12. Participant is of African descent.
Key Trial Info
Start Date :
January 5 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2014
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT00831272
Start Date
January 5 2009
End Date
January 15 2014
Last Update
May 11 2017
Active Locations (4)
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1
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
2
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, United States, 19104
3
University of Pennsylvania Treatment Research Center
Philadelphia, Pennsylvania, United States, 19104
4
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States, 15206