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Trial NCT00000437

Resource URI: http://static.linkedct.org/resource/trials/NCT00000437
PropertyValue
linkedct:brief_title Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)
linkedct:condition <http://static.linkedct.org/resource/condition/12227>
linkedct:condition <http://static.linkedct.org/resource/condition/744>
linkedct:criteria Inclusion Criteria: - Meets criteria for alcohol dependence and nicotine dependence. - Expresses a desire to cut down or stop drinking and smoking. Exclusion Criteria: - Currently meets criteria for dependence on substances other than alcohol and nicotine. - Any history of opiate dependence or evidence of current opiate use. - Significant medical disorders that will increase potential risk or interfere with study participation. - Liver function tests more than 3 times normal or elevated bilirubin. - Females who are pregnant, nursing, or not using a reliable method of birth control. - Meets criteria for a major psychiatric disorder and is in need of or currently undergoing drug therapy. - Inability to understand and/or comply with the provisions of the protocol and consent form. - Treatment with an investigational drug during the previous month. - Chronic treatment with any narcotic-containing medications during the previous month. - Sensitivity to drug as evidenced by adverse drug experiences especially with narcotic- containing analgesics or opioid antagonists. - Current treatment with disulfiram (Antabuse) or nicotine replacement therapy. - More than 6 weeks of abstinence.
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 65 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date December 2003
linkedct:enrollment 166 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000437
rdfs:label Trial NCT00000437
linkedct:lastchanged_date December 7, 2007
linkedct:lead_sponsor_agency National Institute on Alcohol Abuse and Alcoholism (NIAAA)
linkedct:location <http://static.linkedct.org/resource/location/173597>
linkedct:nct_id NCT00000437
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Nalmefene in Nicotine and Alcohol Dependence
linkedct:org_study_id NIAAAMAS11210
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/5159>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000437>
linkedct:phase Phase 4
linkedct:source National Institute on Alcohol Abuse and Alcoholism (NIAAA)
linkedct:study_design Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
linkedct:study_type Interventional
linkedct:summary The purpose of this study is to determine the effectiveness of naltrexone (Revia) in reducing drinking and smoking in patients with both nicotine and alcohol dependence. Individuals will be randomly assigned to a 12-week trial of a fixed daily dose of either naltrexone (Revia) and nicotine replacement patch or placebos. All individuals will receive weekly coping skills and smoking-cessation behavioral therapy. Followup interviews will be conducted 3 and 6 months after treatment to determine smoking and drinking status and persistence of any dependence symptoms.
rdf:type linkedct:trials
linkedct:verification_date December 2007