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Trial NCT00000455

Resource URI: http://static.linkedct.org/resource/trials/NCT00000455
linkedct:brief_title Naltrexone for Early Problem Drinkers
linkedct:condition <http://static.linkedct.org/resource/condition/744>
linkedct:criteria Inclusion Criteria: - Limited to early problem drinkers (i.e., those with no more than mild alcohol dependence). - Have an average weekly alcohol consumption of greater than or equal to 24 standard drinks for men and 18 standard drinks for women. - Able to read English at the eighth grade or higher level and show no evidence of significant cognitive impairment. - Willing to provide a collateral informant for interviews regarding the patient's drinking during the study. - A woman of child-bearing potential must be non-lactating, practicing a reliable method of birth control, and have a negative pregnancy test prior to initiation of treatment. - Willing to provide a signed informed consent to participate in the study. Exclusion Criteria: - Have a current clinically significant physical disease or abnormality. - Have a serious psychiatric illness. - Have a current diagnosis of drug dependence (other than nicotine dependence) or a lifetime diagnosis of opioid dependence. - A current diagnosis of alcohol dependence that is moderate or greater in severity or a history of alcohol withdrawal, or recurrent use of alcohol to alleviate alcohol withdrawal symptoms. - Used opioids or other psychoactive medications regularly in the month prior to study enrollment. - History of hypersensitivity to naltrexone (Revia).
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 September 2002
linkedct:enrollment 160 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000455
rdfs:label Trial NCT00000455
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/149683>
linkedct:nct_id NCT00000455
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Targeted Naltrexone for Early Problem Drinkers
linkedct:org_study_id NIAAAKRA11062
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000455>
linkedct:phase Phase 4
linkedct:source National Institute on Alcohol Abuse and Alcoholism (NIAAA)
linkedct:study_design Treatment, Randomized, Placebo Control, Efficacy Study
linkedct:study_type Interventional
linkedct:summary Early problem drinkers are prevalent in the United States. Recent controlled trials have shown that brief interventions in the primary care setting can reduce drinking and alcohol-related problems in patients who lack evidence of alcohol dependence. Although naltrexone (Revia) has been approved for the treatment of alcohol dependence, few pharmacotherapy studies have been undertaken with early problem drinkers. This study is an 8-week trial of naltrexone versus placebo, combined with coping skills treatment that either focuses on targeted use of medication or serves as background to daily use of the medication. A total of 160 early problem drinkers recruited through screening in primary care medical settings will be randomly assigned to one of four treatment groups. Followup evaluations will be conducted at the end of treatment and again 3, 6, and 12 months.
rdf:type linkedct:trials
linkedct:verification_date November 2004