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Timing of Smoking Intervention in Alcohol Treatment (Nicotine Patch)

Primary Purpose

Alcoholism, Smoking

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
nicotine replacement patch
Sponsored by
Minneapolis Veterans Affairs Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • General Internal Medicine, VA Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
February 10, 2011
Sponsor
Minneapolis Veterans Affairs Medical Center
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00000444
Brief Title
Timing of Smoking Intervention in Alcohol Treatment (Nicotine Patch)
Official Title
Timing of Smoking Intervention in Alcohol Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
September 1997 (undefined)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
January 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Minneapolis Veterans Affairs Medical Center
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Smoking

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
nicotine replacement patch

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
General Internal Medicine, VA Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Timing of Smoking Intervention in Alcohol Treatment (Nicotine Patch)

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