Expired Study
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New Haven, Connecticut 06511


Purpose:

This study will examine whether pretreatment with two doses of acamprosate for seven days prior to abstinence lessens the intensity of acute withdrawal from alcohol compared with a placebo. Subjects will be randomly assigned to receive either one of two doses of acamprosate or placebo for seven days. This will be followed by a four- day inpatient period when withdrawal will be monitored. Additional drinking information will be obtained at a three month followup interview.


Criteria:

Inclusion Criteria: - Meets criteria for alcohol abuse or dependence. - Able to read English at 6th grade level or higher and to complete study evaluations. - Average weekly alcohol consumption of standard drinks of at least 25 drinks for men and 20 drinks for women. - No more than 3 days abstinence/week. Exclusion Criteria: - Current abuse or dependence on other substances, other than nicotine and marijuana. - Positive test results for opiates, cocaine, benzodiazepines and barbiturates. - Regular use of psychoactive drugs including anxiolytics and antidepressants. - Psychiatrically disabled. - Hepatocellular disease or a history of cirrhosis. - Medical conditions that would prevent the consumption of alcohol, increase the risk of complicated alcohol withdrawal, or prevent the use of acamprosate such as a history of neurological trauma or disease, seizures, delirium, or hallucinations, hepatic, cardiovascular, metabolic, endocrine, gastrointestinal, or kidney disease. - Individuals who have had any significant physical illnesses during the two weeks prior to receiving study medication or during the medication treatment period prior to the withdrawal study. - Medically detoxified from alcohol more than once within the past five years. - Alcohol withdrawal symptoms requiring management with benzodiazepines. - Females who are pregnant, nursing or not using a reliable method of birth control. - Individuals who are seeking alcohol treatment or have been in alcohol treatment within the past six months. - Individuals who report disliking spirits and have taken investigational drug or naltrexone within 4 weeks immediately preceding admission to study. - Individuals who report any daily drug use during the thirty days prior to randomization for the following: anxiolytics, beta blockers, central nervous system stimulants, hypnotics, non-therapeutic doses of neuroleptics and antidepressants, drugs with psychotropic activity or drugs which cause excessive sedation. - Subjects who have donated blood within the past six weeks.


NCT ID:

NCT00004552


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

New Haven, Connecticut 06511
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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