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Combination Nicotine Replacement for Alcoholic Smokers
This study has been completed.
Study NCT00064844   Information provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First Received: July 14, 2003   Last Updated: December 7, 2007   History of Changes

July 14, 2003
December 7, 2007
August 2002
 
  • 6 month smoking abstinence
  • 12 month smoking abstinence
Same as current
Complete list of historical versions of study NCT00064844 on ClinicalTrials.gov Archive Site
 
 
 
Combination Nicotine Replacement for Alcoholic Smokers
Combination Nicotine Replacement for Alcoholic Smokers

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.

 
Phase IV
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
  • Smoking
  • Alcoholism
Drug: nicotine patch and nicotine gum
 
Cooney NL, Cooney JL, Perry BL, Carbone M, Cohen EH, Steinberg HR, Pilkey DT, Sevarino K, Oncken CA, Litt MD. Smoking cessation during alcohol treatment: a randomized trial of combination nicotine patch plus nicotine gum. Addiction. 2009 Sep;104(9):1588-96. Epub 2009 Jun 22.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
175
July 2006
 

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 cigarettes 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 verify 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00064844
 
NIAAACOO11197-05
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 
Principal Investigator: Ned Cooney, PhD Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP