Acamprosate Treatment: Mechanisms of Action
Completed · Phase 2
Conditions studied: Alcoholism
In brief
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.
Key facts
- Study ID
- NCT00004552
- Run by
- Yale University
- People needed
- 120
- Expected to finish
- 2002-12-01
- Last updated by the study team
- 2015-07-02
Who can join
Age: 21 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Substance Abuse Treatment Unit, University of Connecticut — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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