Acamprosate Treatment: Mechanisms of Action

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004552
Recruitment Status : Completed
First Posted : February 4, 2000
Last Update Posted : July 2, 2015
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:
Yale University

Brief 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.

Condition or disease Intervention/treatment Phase
Alcoholism Drug: acamprosate (Campral) Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Etiology and Treatment of Alcohol Dependence
Study Completion Date : December 2002

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004552

United States, Connecticut
Substance Abuse Treatment Unit, University of Connecticut
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA) Identifier: NCT00004552     History of Changes
Other Study ID Numbers: NIAAAOMA03510
P50AA003510 ( U.S. NIH Grant/Contract )
First Posted: February 4, 2000    Key Record Dates
Last Update Posted: July 2, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Alcohol Deterrents