Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ned Cooney, Yale University
ClinicalTrials.gov Identifier:
NCT00861146
First received: March 11, 2009
Last updated: February 27, 2014
Last verified: February 2014
Results First Received: January 15, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Tobacco Use Cessation
Alcohol-related Disorders
Intervention: Behavioral: behavioral counseling plus contingency management

  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

Enrollment May 2009 to October 2012.

Excluded (n=1448):

Does not smoke, does not drink (n=678) Declined to participate (n=320) Medical problems (n=297) Otherwise ineligible (n=112) Male non-vet (n=41)


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
1 Concurrent Smoking Cessation

smoking cessation delivered concurrent with intensive alcohol treatment

behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum

2 Deferred Smoking Cessation

smoking cessation delivered 12 weeks after intensive alcohol treatment

behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum


Participant Flow:   Overall Study
    1 Concurrent Smoking Cessation     2 Deferred Smoking Cessation  
STARTED     105     46  
Week 2 Assessment     97     45  
Week 13 Assessment     85     38  
COMPLETED     85     38  
NOT COMPLETED     20     8  



  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
1 Concurrent Smoking Cessation

smoking cessation delivered concurrent with intensive alcohol treatment

behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum

2 Deferred Smoking Cessation

smoking cessation delivered 12 weeks after intensive alcohol treatment

behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum

Total Total of all reporting groups

Baseline Measures
    1 Concurrent Smoking Cessation     2 Deferred Smoking Cessation     Total  
Number of Participants  
[units: participants]
  105     46     151  
Age  
[units: years]
Mean ± Standard Deviation
  49.5  ± 9.07     48.1  ± 8.68     49.1  ± 8.95  
Gender  
[units: participants]
     
Female     14     7     21  
Male     91     39     130  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     43     20     63  
White     57     25     82  
More than one race     0     0     0  
Unknown or Not Reported     5     1     6  
Region of Enrollment  
[units: participants]
     
United States     105     46     151  
Cigarettes smoked/day  
[units: cigarettes]
Mean ± Standard Deviation
  16.0  ± 8.0     16.8  ± 10.0     16.2  ± 8.7  
Proportion days heavy drinking [1]
[units: proportion]
Mean ± Standard Deviation
  .58  ± .33     .52  ± .38     .56  ± .35  
[1] Heavy drinking days were defined as days with > 6 standard drinks per day for men and > 4 standard drinks per day for women. The baseline measure examined the proportion of heavy drinking days in the 90 days prior to the last day of reported drinking prior to study enrollment.



  Outcome Measures
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1.  Primary:   Smoking Abstinence   [ Time Frame: 12 weeks ]

2.  Primary:   Smoking Abstinence   [ Time Frame: 2 weeks ]

3.  Secondary:   Proportion of Days Heavy Drinking   [ Time Frame: follow-up weeks 9-12 ]


  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: Ned L. Cooney, PhD
Organization: Yale University School of Medicine
phone: 860-594-6339
e-mail: ned.cooney@yale.edu


No publications provided


Responsible Party: Ned Cooney, Yale University
ClinicalTrials.gov Identifier: NCT00861146     History of Changes
Other Study ID Numbers: NIAAA-Cooney-AA011197, R01AA011197, NIH Grant R01AA011197
Study First Received: March 11, 2009
Results First Received: January 15, 2014
Last Updated: February 27, 2014
Health Authority: United States: Federal Government