Acamprosate Treatment: Mechanisms of Action
This study has been completed.
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First received: February 3, 2000
Last updated: November 4, 2005
Last verified: November 2004
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.
Drug: acamprosate (Campral)
Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
||Etiology and Treatment of Alcohol Dependence
| Estimated Enrollment:
| Estimated Study Completion Date:
|Ages Eligible for Study:
||21 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004552
|Substance Abuse Treatment Unit, University of Connecticut
|New Haven, Connecticut, United States, 06511 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 3, 2000
||November 4, 2005
||United States: Federal Government
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Central Nervous System Agents