Improving Smoking Cessation Outcomes in Heavy Drinkers - 1

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00107575
First received: April 5, 2005
Last updated: May 24, 2010
Last verified: May 2010
Results First Received: November 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   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
No text entered.

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  
Number of Participants  
[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
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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 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: May 24, 2010
Health Authority: United States: Federal Government