Combination Nicotine Replacement for Alcoholic Smokers

This study has been completed.

First Received: July 14, 2003 Last Updated: December 7, 2007 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism Smoking

Drug Information available for: Nicotine tartrate Nicotine polacrilex

U.S. FDA Resources

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

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator:

Ned Cooney, PhD

Yale University

More Information

No publications provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

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

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

Smoking
Alcoholism

Additional relevant MeSH terms:

Nicotine polacrilex
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Agonists
Nicotinic Agonists
Physiological Effects of Drugs
Disorders of Environmental Origin
Central Nervous System Stimulants
Cholinergic Agents
Pharmacologic Actions
Smoking

Habits
Mental Disorders
Nicotine
Autonomic Agents
Therapeutic Uses
Alcoholism
Substance-Related Disorders
Ganglionic Stimulants
Alcohol-Related Disorders
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009