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Tobacco Dependence in Alcoholism Treatment (nicotine patch/naltrexone)



Tobacco Dependence in Alcoholism Treatment (nicotine patch/naltrexone)

For Condition: Alcoholism,Smoking
Status: Recruiting
Sponsor(s): National Institute on Alcohol Abuse and Alcoholism (NIAAA) ,
Synopsis: 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.
Details:
Eligibility:
Study Type:  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 166

Location and Contact Information:

Department of Psychiatry, University of Miami School of Medicine *Recruiting*
Miami,  Florida,  33136
United States
Recruiting Dr.  Mason 305-243-4644


Additional Information:
Study ID Numbers:  NIAAAMAS11210; 
Study Start Date: 
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000437

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