Acamprosate Treatment: Mechanisms of Action

NCT00004552 | Completed Phase 2

• 2 other identifiers: NIAAAOMA03510P50AA003510
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Interventions

acamprosate (Campral) DRUG

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Substance Abuse Treatment Unit, University of Connecticut

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Acamprosate

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Taurine; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 3, 2000
• First Posted: February 4, 2000
• Study Completion: December 1, 2002
• Last Updated: July 2, 2015

Record last verified: 2015-06

Locations

US (1)