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Combination Nicotine Replacement for Alcoholic Smokers

This study has been completed.

Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT00064844
  Purpose

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.


Condition Intervention Phase
Smoking
Alcoholism
Drug: nicotine patch and nicotine gum
Phase IV

MedlinePlus related topics:   Alcoholism    Smoking   

ChemIDplus related topics:   Nicotine polacrilex    Nicotine tartrate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Combination Nicotine Replacement for Alcoholic Smokers

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:
  • 6 month smoking abstinence
  • 12 month smoking abstinence

Estimated Enrollment:   175
Study Start Date:   August 2002
Study Completion Date:   July 2006

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064844

Locations
United States, Connecticut
VA Connecticut Healthcare System    
      Newington, Connecticut, United States, 06111

Sponsors and Collaborators

Investigators
Principal Investigator:     Ned Cooney, PhD     Yale University    
  More Information

Study ID Numbers:   NIAAACOO11197-05
First Received:   July 14, 2003
Last Updated:   December 7, 2007
ClinicalTrials.gov Identifier:   NCT00064844
Health Authority:   United States: Federal Government

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):
Smoking  
Alcoholism  

Study placed in the following topic categories:
Nicotine polacrilex
Smoking
Nicotine
Mental Disorders
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin
Alcohol-Related Disorders

Additional relevant MeSH terms:
Neurotransmitter Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Nicotinic Agonists
Physiological Effects of Drugs
Central Nervous System Stimulants
Cholinergic Agents
Pharmacologic Actions
Habits
Autonomic Agents
Therapeutic Uses
Ganglionic Stimulants
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2008




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