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Improving Smoking Cessation Outcomes in Heavy Drinkers - 1

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christopher W. Kahler, Brown University
ClinicalTrials.gov Identifier:
NCT00107575
First received: April 5, 2005
Last updated: September 20, 2016
Last verified: September 2016
Results First Received: November 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Tobacco Use Disorder
Interventions: Behavioral: Standard treatment plus brief alcohol intervention
Other: Standard treatment (ST)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Standard Treatment Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention

Participant Flow:   Overall Study
    Standard Treatment   Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)
STARTED   119   117 
COMPLETED   108   107 
NOT COMPLETED   11   10 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Standard Treatment Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
Total Total of all reporting groups

Baseline Measures
   Standard Treatment   Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)   Total 
Overall Participants Analyzed 
[Units: Participants]
 119   117   236 
Age 
[Units: Participants]
     
<=18 years   2   0   2 
Between 18 and 65 years   113   112   225 
>=65 years   4   5   9 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.6  (12.1)   42.3  (11.8)   41.5  (12.0) 
Gender 
[Units: Participants]
     
Female   53   53   106 
Male   66   64   130 
Region of Enrollment 
[Units: Participants]
     
United States   119   117   236 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Smoking Abstinence at 26 Weeks   [ Time Frame: 26 weeks ]

2.  Primary:   Smoking Abstinence at 16 Weeks   [ Time Frame: 16 weeks ]

3.  Primary:   Smoking Abstinence at 8 Weeks   [ Time Frame: 8 weeks ]

4.  Primary:   Smoking Abstinence at 2 Weeks   [ Time Frame: 2 weeks ]

5.  Secondary:   Alcohol Drinks Consumed Per Week Over a 2-week Period   [ Time Frame: At 2, 8, 16, and 26-week follow-ups ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Christopher Kahler
Organization: Brown University
phone: (401) 863-6651
e-mail: Christopher_Kahler@brown.edu


Publications of Results:

Responsible Party: Christopher W. Kahler, Brown University
ClinicalTrials.gov Identifier: NCT00107575     History of Changes
Other Study ID Numbers: NIDA-15534-1
R01-15534-1
Study First Received: April 5, 2005
Results First Received: November 30, 2009
Last Updated: September 20, 2016