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
  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:


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

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 April 17, 2014