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Combination Nicotine Replacement for Alcoholic Smokers



Combination Nicotine Replacement for Alcoholic Smokers

For Condition: Smoking,Alcoholism
Status: Recruiting
Sponsor(s): National Institute on Alcohol Abuse and Alcoholism (NIAAA) ,
Synopsis: The overall objective of the study is to develop recommendations for treatment programs to help alcoholic smokers to stop smoking. A sample of 175 alcohol dependent cigarette smokers will be recruited from the community and treated in a 6-month outpatient alcohol and tobacco treatment program. The 175 patients will be divided into two groups. One group will receive an active nicotine patch and active nicotine gum. The other group will receive an active nicotine patch and placebo nicotine gum. Followup assessments will be conducted for 1-year from the beginning of treatment.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion criteria: - Males and females at least 18 years old. - English speaking. - Meets criteria for alcohol dependence or alcohol abuse. - Must complete an alcohol detoxification program prior to entering the study. - Currently smoking 15 or more cigaretts per day and have at least a 3 year history of smoking. - Have a current desire to stop smoking and stop drinking. - Willing to complete followup assessments up to 12 months after treatment. - Willing to provide names of 2 people who can help locate the subject at followup and the name of one person who can varify information about alcohol and tobacco use. - One person per household. Exclusion Criteria: - Allergy to nicotine patch or nicotine gum. - Weigh less than 100 pounds. - Use other nicotine products, such as cigars, pipes or smokeless tobacco. - Severe skin disorder. - Active peptic ulcer. - Active joint disease. - Heart attack within 3 months prior to entering the study. - Pregnant or breastfeeding female who are not on birth control. - Currently taking medication to treat alcoholism or smoking, such as naltrexone, disulfiram or bupropion. - Poor vision or hearing that would interfere with using a cell phone. - Lack of transportation to the treatment site or live at least one hour from the treatment site. - Homeless.
Total Enrollment: 175

Location and Contact Information:

VA Connecticut Healthcare System *Recruiting*
Newington,  Connecticut,  06111
United States
Recruiting Dr.  Cooney 860-594-6339


Additional Information:
Study ID Numbers:
  NIAAACOO11197-05; 
Study Start Date: 
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064844

Other Smoking Studies:
1. Preliminary Human Trial of NPI-028

2. Timing of Smoking Intervention in Alcohol Treatment (nicotine patch)

3. Pharmacologic Relapse Prevention for Alcoholic Smokers

4. Behavioral Counseling for Alcohol Dependent Smokers (nicotine patch)

5. Sertraline for Alcohol Dependence and Depression

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Combination Nicotine Replacement for Alcoholic Smokers

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