Combination Nicotine Replacement for Alcoholic Smokers

Completed · Phase 4 · Has a placebo group

Conditions studied: Smoking, Alcoholism

In brief

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.

Key facts

Study ID

NCT00064844

Run by

Yale University

People needed

96

Starts

2002-08-01

Expected to finish

2006-07-01

Last updated by the study team

2021-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• VA Connecticut Healthcare System — Newington, Connecticut, United States

Full record on ClinicalTrials.gov

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