Acamprosate Treatment: Mechanisms of Action

NCT ID: NCT00004552

Last Updated: 2015-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2002-12-31

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.

Conditions

Alcoholism

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

acamprosate (Campral)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Locations

Substance Abuse Treatment Unit, University of Connecticut

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

P50AA003510

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIAAAOMA03510

Identifier Type: -

Identifier Source: org_study_id