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Trial NCT00000442

Resource URI: http://static.linkedct.org/resource/trials/NCT00000442
linkedct:brief_title Naltrexone for Relapse Prevention
linkedct:condition <http://static.linkedct.org/resource/condition/744>
linkedct:criteria Inclusion Criteria: - Meets criteria for alcohol dependence. - Abstinent from alcohol for a period of at least 3 days prior to beginning of study. - Able to read English and complete study evaluations. - Females who are postmenopausal, have had surgical sterilization, or use reliable means of birth control. Exclusion Criteria: - Meets criteria for dependence on a psychoactive substance other than alcohol and nicotine and/or cannabis. - Prior history of opioid dependence. - Regular use of psychoactive drugs including anxiolytics and antidepressants. - Prior treatment with naltrexone. - Current use of disulfiram. - Psychotic or otherwise severely psychiatrically disabled (e.g., suicidal, current mania). - Significant underlying medical conditions such as hepatic, cerebral, renal, thyroid, or cardiac disease. - Abstinent longer than 28 days prior to randomization.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 60 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date December 2002
linkedct:enrollment 57 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000442
rdfs:label Trial NCT00000442
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Institute on Alcohol Abuse and Alcoholism (NIAAA)
linkedct:location <http://static.linkedct.org/resource/location/149682>
linkedct:nct_id NCT00000442
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Etiology and Treatment of Alcohol Dependence
linkedct:org_study_id NIAAAKRA3510
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000442>
linkedct:phase Phase 4
linkedct:source National Institute on Alcohol Abuse and Alcoholism (NIAAA)
linkedct:study_design Treatment, Placebo Control, Parallel Assignment, Safety/Efficacy Study
linkedct:study_type Interventional
linkedct:summary This study is to evaluate the safety and effectiveness of an injectable slow releasing preparation of naltrexone to reduce alcohol consumption and risk of relapse in alcohol-dependent subjects. Individuals will receive either naltrexone or a placebo injection for a total of three months, with two subsequent followup visits spanning a 6- month period.
rdf:type linkedct:trials
linkedct:verification_date November 2004