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Trial NCT00000456

Resource URI: http://static.linkedct.org/resource/trials/NCT00000456
linkedct:brief_title Behavioral Therapy Plus Naltrexone for Alcoholism
linkedct:condition <http://static.linkedct.org/resource/condition/714>
linkedct:condition <http://static.linkedct.org/resource/condition/744>
linkedct:criteria Inclusion Criteria: - Meets criteria for alcohol dependence, has not had more than one previous inpatient medical detoxification. - Consumes on average five standard drinks per day. - Able to maintain sobriety for five days (with or without the aid of detoxification medications) as determined by self-report, collateral report, and breathalyzer measurements. - Able to read and understand questionnaires and informed consent. - Lives within 50 miles of the study site. Exclusion Criteria: - Currently meets criteria for any other psychoactive substance dependency disorder. - Ever abused opiates. - Used psychoactive substance abuse, except marijuana, within the last 30 days as evidenced by patient report, collateral report, and urine drug screen. - Meets criteria for disorders of major depression, panic disorder, obsessive-compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, schizophrenia, or any other psychotic disorder or organic mental disorder. - Meets criteria for dissociate disorder or eating disorders. - Has current suicidal or homicidal ideation. - Need for maintenance or acute treatment with any psychoactive medication including antiseizure medications. - Current use of disulfiram (Antabuse). - Clinically significant medical problems that would impair participation or limit medication ingestion. - Hepatocellular disease. - Sexually active females of child bearing potential who are pregnant, nursing, or who are not using a reliable form of birth control. - Have current charges pending for a violent crime. - Does not have a stable living situation and a reliable source of collateral reporting. - Has taken an opiate antagonist drug in the last month.
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 70 Years
linkedct:eligibility_minimum_age 21 Years
linkedct:end_date August 2002
linkedct:enrollment 160 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000456
rdfs:label Trial NCT00000456
linkedct:lastchanged_date November 26, 2007
linkedct:lead_sponsor_agency National Institute on Alcohol Abuse and Alcoholism (NIAAA)
linkedct:location <http://static.linkedct.org/resource/location/168871>
linkedct:nct_id NCT00000456
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Comparison of Cognitive Behavioral Therapy and Motivational Enhancement Therapy Plus Naltrexone for Alcoholism
linkedct:org_study_id NIAAAANT09568
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/48990>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000456>
linkedct:phase Phase 4
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/4909>
linkedct:source National Institute on Alcohol Abuse and Alcoholism (NIAAA)
linkedct:start_date September 1992
linkedct:study_design Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct:summary This study will compare cognitive behavioral therapy with a time-limited motivational enhancement therapy to which naltrexone (Revia) or placebo medication is added. In this randomized clinical trial, 160 alcohol-dependent outpatients, after 5 days of abstinence, will receive one of the two psychosocial therapies and either naltrexone (Revia) or placebo for a 12-week treatment period. Abstinence rates, alcohol use, and time to alcohol relapse will be evaluated in all four groups along with measures of alcohol craving, biological measures of alcohol consumption, drinking consequences, changes in self-confidence for avoiding alcohol, and medication compliance. All study participants will be assessed for measures of outcome variables at 3 and 6 months after completing the treatment protocol.
rdf:type linkedct:trials
linkedct:verification_date November 2007