Combined Treatment for Tobacco and Alcohol Use

This study has been terminated.
(No patients registered; study terminated.)
Sponsor:
Information provided by:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00592085
First received: December 27, 2007
Last updated: October 7, 2009
Last verified: September 2009
Results First Received: September 8, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Smoking Cessation
Interventions: Behavioral: Questionnaires
Behavioral: Motivational Relapse Prevention Counseling
Behavioral: Relapse Plus Alcohol Risk Reduction Counseling

  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
Recruitment Period: 12/21/07 through 11/12/08. All attempted recruitment done at UT MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No participants enrolled on this study. Almost identical study now being conducted with varied population.

Reporting Groups
  Description
Relapse Prevention Counseling No text entered.
Relapse Prevention + Alcohol Counseling Motivational Relapse Prevention Plus Alcohol Risk Reduction Counseling

Participant Flow:   Overall Study
    Relapse Prevention Counseling     Relapse Prevention + Alcohol Counseling  
STARTED     0     0  
COMPLETED     0     0  
NOT COMPLETED     0     0  



  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.
No text entered.

Reporting Groups
  Description
Relapse Prevention Counseling No text entered.
Relapse Prevention + Alcohol Counseling Motivational Relapse Prevention Plus Alcohol Risk Reduction Counseling
Total Total of all reporting groups

Baseline Measures
    Relapse Prevention Counseling     Relapse Prevention + Alcohol Counseling     Total  
Number of Participants  
[units: participants]
  0     0     0  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     0     0     0  
Male     0     0     0  



  Outcome Measures

1.  Primary:   Overall At-risk Drinking Status   [ Time Frame: Baseline and Week 12 ]

2.  Secondary:   Effectiveness of Certain Type of Telephone Counseling Ability to Help Participants Decrease Both Their Smoking and At-risk Alcohol Use.   [ Time Frame: 2 Years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: David Wetter, PHD, MS, BA /Professor
Organization: UT MD Anderson Cancer Center
phone: 713-745-2682


No publications provided


Responsible Party: David Wetter, PHD, MS, BA /Professor, U.T. M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00592085     History of Changes
Other Study ID Numbers: 2007-0111
Study First Received: December 27, 2007
Results First Received: September 8, 2009
Last Updated: October 7, 2009
Health Authority: United States: Institutional Review Board