Expired Study
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Minneapolis, Minnesota 55417


Purpose:

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.


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.


Study is Available At:


Original ID:

NIAAAJOS11124


NCT ID:

NCT00000444


Secondary ID:

R01AA011124


Study Acronym:


Brief Title:

Timing of Smoking Intervention in Alcohol Treatment (Nicotine Patch)


Official Title:

Timing of Smoking Intervention in Alcohol Treatment


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

21 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Minneapolis Veterans Affairs Medical Center


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

500


Enrollment Type:


Study Dates

Start Date:September 1997
Completion Date:January 2004
Completion Type:Actual
Primary Completion Date:January 2004
Primary Completion Type:Actual
Verification Date:January 2008
Last Changed Date:February 10, 2011
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:nicotine replacement patch

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:Minneapolis Veterans Affairs Medical Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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