Acamprosate Treatment: Mechanisms of Action

• Status: Completed
• Trial end date: 2002-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Acamprosate

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.