NCT00004552

CompletedPhase 2

Acamprosate Treatment: Mechanisms of Action

Yale University Source

Compare

Other study identifiers

Sponsor study identifier

NIAAAOMA03510

Secondary identifiers

P50AA003510

NIH

Study Type

interventional

Reported enrollment (type unavailable)

120

Locations

1 country

Sites

1

Timeline

Study Start

Not reported

Date not reported

Primary Completion

Not reported

Date not reported

Study Completion

December 2002

Date type not reported

This date has not been verified as actual or estimated.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 120 participants
Study completion date: December 2002
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
February 3, 2000
Actual (reported)
First Posted
February 4, 2000
Actual (reported)
Study Completion
December 2002
Date type not reported
This date has not been verified as actual or estimated.

Last Updated: July 2, 2015
Status Verified: June 2015
Last Update Submitted: June 30, 2015

Conditions

Alcoholism

Interventions

acamprosate (Campral)Drug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age21 Years - 55 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Yale University
Otherlead
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIHcollaborator

Study Sites (1)

Substance Abuse Treatment Unit, University of Connecticut

New Haven, Connecticut, 06511, United States

MeSH Terms

Conditions

Alcoholism

Interventions

Acamprosate

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TaurineAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsSulfonic Acids

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 2002

Date type not reported

This date has not been verified as actual or estimated.

Last Updated

July 2, 2015

Record last verified: 2015-06

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00004552
Data provider: ClinicalTrials.gov
Source updated: 2015-07-02
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:36:55 UTC

NCT00655967

Safety of Acamprosate for Alcohol Dependence in the Elderly: An Open-Label Study (SAFADIE)

Phase 4Withdrawn

NCT00605904

Modulation of Pharmacologically Induced Alcohol Craving in Recently Detoxified Alcoholics

Phase 2Completed

NCT00006206

COMBINE (Acamprosate/Naltrexone)

Phase 3Completed

NCT02251912

Oxytocin Treatment of Alcohol Dependence

Phase 2Completed

NCT00804570

A Study for the Treatment of Alcohol Dependence

Phase 2Completed

NCT00011297

Comparing Gabapentin and Lorazepam for Treating Alcohol Withdrawal

Phase 2Completed

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.

Contact the study team to confirm eligibility.

Sulfur Acids

Sulfur Compounds

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Completion

Conditions

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Design

Study Record Dates

Source record

You may not qualify if:

Locations