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Trial NCT00000445

Resource URI: http://static.linkedct.org/resource/trials/NCT00000445
linkedct:brief_title Use of Naltrexone in a Clinical Setting
linkedct:condition <http://static.linkedct.org/resource/condition/744>
linkedct:criteria Inclusion Criteria: - Meets criteria for alcohol dependence (within the past 3 months). - Meets criteria for another substance use disorder (except narcotic dependence) but must identify alcohol as the primary substance of abuse. - Must be able to provide an informed consent. - Consent to random assignment and be willing to commit to possible medication treatment and research follow-up. - Must be eligible for treatment at the Dorchester Alcohol and Drug Commission. Exclusion Criteria: - Meets criteria for opiate dependence. - Clinically significant medical problems such as collagen-vascular disease, cardiovascular, renal, gastrointestinal or endocrine problem that would impair participation or limit medication ingestion. - Hepatocellular disease. - Women who are pregnant, nursing, or not practicing an effective means of birth control. - Currently being prescribed naltrexone. - Known sensitivity or allergy to naltrexone.
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 N/A
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date September 2002
linkedct:enrollment 300 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000445
rdfs:label Trial NCT00000445
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/168832>
linkedct:nct_id NCT00000445
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Effectiveness of Naltrexone in a Community Setting
linkedct:org_study_id NIAAABRA11747
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000445>
linkedct:phase Phase 4
linkedct:source National Institute on Alcohol Abuse and Alcoholism (NIAAA)
linkedct:study_design Treatment, Randomized, Open Label, Placebo Control, Efficacy Study
linkedct:study_type Interventional
linkedct:summary This 12-week trial will compare individuals receiving naltrexone or placebo plus substance abuse counseling therapy versus those receiving only substance abuse counseling therapy in a rural, nonacademic setting. A followup period of 12 months is included. The effect on service utilization and the cost of the addition of naltrexone to treatment services for alcohol dependence also will be assessed. The study will expand existing research concerning the effectiveness of naltrexone in clinical trials versus a clinical setting.
rdf:type linkedct:trials
linkedct:verification_date July 2003