Timing of Smoking Intervention in Alcohol Treatment (Nicotine Patch)

Smoking Clinical Trial

Official title:

Timing of Smoking Intervention in Alcohol Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000444
• Other study ID #: NIAAAJOS11124
• Secondary ID: R01AA011124
• Status: Completed
• Phase: Phase 4
• First received: November 2, 1999
• Last updated: February 10, 2011
• Start date: September 1997
• Est. completion date: January 2004

Study information

• Verified date: January 2008
• Source: Minneapolis Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism
• Smoking

Intervention

Drug:
• nicotine replacement patch

Locations

Country	Name	City	State
United States	General Internal Medicine, VA Medical Center	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Minneapolis Veterans Affairs Medical Center	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States,