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Acamprosate Treatment: Mechanisms of Action

This study has been completed.
Sponsor:
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:
NCT00004552
First received: February 3, 2000
Last updated: November 4, 2005
Last verified: November 2004
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
Official Title: Etiology and Treatment of Alcohol Dependence

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism
U.S. FDA Resources

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
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  More Information

No publications provided

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

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

ClinicalTrials.gov processed this record on May 21, 2013