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Trial NCT00000447

Resource URI: http://static.linkedct.org/resource/trials/NCT00000447
linkedct:brief_title Behavioral/Drug Therapy for Alcohol-Nicotine Dependence (Naltrexone/Nicotine Patch)
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 and nicotine dependence. - Individuals will be outpatients with alcohol and nicotine dependence who have completed detoxification (medicated or nonmedicated) within the past 48-120 hours. - Smoking no less than 10 cigarettes/day and no greater than 50 cigarettes/day. - Motivated to quit smoking. - Willing and able to participate in the 12 week outpatient treatment. - Acceptable health. - Able to provide a collateral informant. - Willing to be followed for 6 months after treatment ends. - Willing and able to provide the names of three family members or friends to aid in locating participants for follow-up. Exclusion Criteria: - Current diagnosis of dependence on other substances except nicotine and alcohol. - Having moderately severe or severe alcohol withdrawal symptoms. - Recent (less than 48 hours) evidence of hazardous drinking (more than 2 drinks/day for females; 3 drinks/day for males). - History of opioid abuse. - Recent use of cocaine. - Not desiring to quit smoking. - Recent past or current pharmacotherapy involving naltrexone or transdermal nicotine systems. - History of psychosis. - Current suicidality, homicidally or psychiatric symptoms requiring other medications. - Presence of medical abnormalities that contraindicate naltrexone or nicotine replacement therapy. - Current treatment with psychotropic medications. - Pregnancy or nursing for female patients. Inability or unwillingness to participate in the 12-week outpatient treatment.
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 50 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date May 2003
linkedct:enrollment 200 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000447
rdfs:label Trial NCT00000447
linkedct:lastchanged_date December 6, 2007
linkedct:lead_sponsor_agency National Institute on Alcohol Abuse and Alcoholism (NIAAA)
linkedct:location <http://static.linkedct.org/resource/location/201896>
linkedct:nct_id NCT00000447
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Behavioral/Pharmacological Treatments for Alcohol-Nicotine Dependence
linkedct:org_study_id NIAAA-SCHMITZ-11216-04
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/30681>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000447>
linkedct:phase Phase 4
linkedct:secondary_id NIH Grant 5R01AA011216-04
linkedct:source National Institute on Alcohol Abuse and Alcoholism (NIAAA)
linkedct:start_date September 1998
linkedct:study_design Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct:summary This study will develop a behavioral and drug relapse prevention program for individuals who are dependent on both alcohol and tobacco. The study's goal is to show that individuals receiving nicotine replacement therapy and naltrexone (Revia) with behavior therapy will have higher rates of abstinence from both smoking and drinking than individuals who do not receive the drug therapies. Individuals will be placed in a 12-week outpatient treatment program with followup assessments 1, 3, and 6 months after treatment.
rdf:type linkedct:trials
linkedct:verification_date December 2007