Acamprosate Treatment: Mechanisms of Action
This study has been completed.
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 acramprosate 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
|
Treatment or Intervention |
Phase |
Alcoholism
|
Drug: acamprosate (Campral)
|
Phase II
|
MedlinePlus related topics: Alcoholism
Study Type: Interventional
Study Design: Treatment, Randomized, Placebo Control, Efficacy Study
Official Title: Etiology and Treatment of Alcohol Dependence
Further Study Details:
Expected Total Enrollment:
120
Study completion: December 2002
Eligibility
Ages Eligible for Study:
21 Years
-
55 Years,
Genders Eligible for Study:
Both
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.
Location
Information
Connecticut Substance Abuse Treatment Unit, University of Connecticut, New Haven,
Connecticut,
06511,
United States
More Information
Study ID Numbers:
NIAAAOMA03510
Record last reviewed:
July 2003
Record first received:
February 3, 2000
ClinicalTrials.gov Identifier:
NCT00004552Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-20