Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Timing of Smoking Intervention in Alcohol Treatment (Nicotine Patch)

This study has been completed.
Information provided by:
Minneapolis Veterans Affairs Medical Center Identifier:
First received: November 2, 1999
Last updated: February 10, 2011
Last verified: January 2008

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 Intervention Phase
Drug: nicotine replacement patch
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: Timing of Smoking Intervention in Alcohol Treatment

Resource links provided by NLM:

Further study details as provided by Minneapolis Veterans Affairs Medical Center:

Estimated Enrollment: 500
Study Start Date: September 1997
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00000444

United States, Minnesota
General Internal Medicine, VA Medical Center
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
  More Information

No publications provided Identifier: NCT00000444     History of Changes
Other Study ID Numbers: NIAAAJOS11124, R01AA011124
Study First Received: November 2, 1999
Last Updated: February 10, 2011
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on November 24, 2014