NCT00000444

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 1997

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1997

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 1999

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
Last Updated

February 11, 2011

Status Verified

January 1, 2008

Enrollment Period

6.3 years

First QC Date

November 2, 1999

Last Update Submit

February 10, 2011

Conditions

AlcoholismSmoking

Interventions

nicotine replacement patchDRUG

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Internal Medicine, VA Medical Center

Minneapolis, Minnesota, 55417, United States

Location

MeSH Terms

Conditions

AlcoholismSmoking

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
FED

Study Record Dates

First Submitted

November 2, 1999

First Posted

November 3, 1999

Study Start

September 1, 1997

Primary Completion

January 1, 2004

Study Completion

January 1, 2004

Last Updated

February 11, 2011

Record last verified: 2008-01

Locations

US(1)