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Timing of Smoking Intervention in Alcohol Treatment (Nicotine Patch)

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ClinicalTrials.gov Identifier: NCT00000444
Recruitment Status : Completed
First Posted : November 3, 1999
Last Update Posted : February 11, 2011
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Study Description
Brief Summary:
This study will attempt to determine the best time to begin a smoking cessation program in individuals who undergo intensive treatment for alcohol dependence. The goal of this trial is to determine whether a smoking cessation program is more effective if it occurs at the same time as or after treatment for alcohol dependence. The study also will attempt to determine the effect of smoking cessation programs on the outcome of treatment for alcohol dependence.

Condition or disease Intervention/treatment Phase
Alcoholism Smoking Drug: nicotine replacement patch Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Timing of Smoking Intervention in Alcohol Treatment
Study Start Date : September 1997
Primary Completion Date : January 2004
Study Completion Date : January 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Meets criteria for alcohol use disorder and other drug dependence.
  • Complete first week of alcohol treatment program.
  • Current cigarette smoker (more than 5 cigarettes/day, smoking more than 1 year).

Exclusion Criteria:

  • Lifetime diagnosis of an excluding psychiatric disorder: bipolar disorder, schizophrenia or other psychotic disorder, panic disorder with or without agoraphobia, obsessive-compulsive disorder, generalized anxiety disorder, eating disorder, post- traumatic stress disorder, antisocial personality disorder, or borderline personality disorder.
  • Unable to participate in protocol due to functional deficits or severe depression.
  • Suicidal or homicidal ideation.
  • Current use of disulfiram (Antabuse) or naltrexone (Revia).
  • Current use of pipes, cigars, or smokeless tobacco and unwillingness to stop.
  • Lives more than 100 miles from alcohol treatment facility.
  • No telephone.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000444

United States, Minnesota
General Internal Medicine, VA Medical Center
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
More Information

ClinicalTrials.gov Identifier: NCT00000444     History of Changes
Other Study ID Numbers: NIAAAJOS11124
R01AA011124 ( U.S. NIH Grant/Contract )
First Posted: November 3, 1999    Key Record Dates
Last Update Posted: February 11, 2011
Last Verified: January 2008

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action