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Acamprosate Treatment: Mechanisms of Action

Primary Purpose

Alcoholism

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
acamprosate (Campral)
Sponsored by
Yale University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Substance Abuse Treatment Unit, University of Connecticut

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 3, 2000
Last Updated
June 30, 2015
Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00004552
Brief Title
Acamprosate Treatment: Mechanisms of Action
Official Title
Etiology and Treatment of Alcohol Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
acamprosate (Campral)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Substance Abuse Treatment Unit, University of Connecticut
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States

12. IPD Sharing Statement

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Acamprosate Treatment: Mechanisms of Action

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