Clinical trial NCT00004552: Acamprosate Treatment: Mechanisms of Action
Official title: Etiology and Treatment of Alcohol Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcoholism
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2000-02-04
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Substance Abuse Treatment Unit, University of Connecticut
state: Connecticut
Study officials:
References: