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Related Studies
Acamprosate Treatment: Mechanisms of Action
This study has been completed.
First Received: February 3, 2000   Last Updated: November 4, 2005   History of Changes
Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT00004552
  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.


Condition Intervention Phase
Alcoholism
Drug: acamprosate (Campral)
Phase II

MedlinePlus related topics: Alcoholism
Drug Information available for: Acamprosate calcium Acamprosate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Placebo Control, Efficacy Study
Official Title: Etiology and Treatment of Alcohol Dependence

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Estimated Enrollment: 120
Estimated Study Completion Date: December 2002
  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004552

Locations
United States, Connecticut
Substance Abuse Treatment Unit, University of Connecticut
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
  More Information

No publications provided

Study ID Numbers: NIAAAOMA03510
Study First Received: February 3, 2000
Last Updated: November 4, 2005
ClinicalTrials.gov Identifier: NCT00004552     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Mental Disorders
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin
Alcohol-Related Disorders
Acamprosate
Ethanol

Additional relevant MeSH terms:
Mental Disorders
Therapeutic Uses
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin
Alcohol-Related Disorders
Central Nervous System Agents
Pharmacologic Actions
Alcohol Deterrents
Acamprosate

ClinicalTrials.gov processed this record on May 07, 2009