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.
- 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.
- 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.