Varenicline For Smokers In Recovery From Alcohol Dependence

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01092702
First received: March 19, 2010
Last updated: April 15, 2011
Last verified: April 2011
Results First Received: October 28, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Tobacco Abstinence
Intervention: Drug: Varenicline

  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 began on 04/14/2008 and finished on 08/28/2008. Recruitment was in the general community of Rochester, Minnesota

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All potential participants consenting to enrollment completed a series of screening questionnaires. The questionnaires included demographic information, alcohol and smoking history, the the Center for Epidemiological Studies–Depressed Mood Scale, DAST-20, medical history and physical exam.

Reporting Groups
  Description
Varenicline Everyone on study received Varenicline (2 mg/day) daily for 12 weeks

Participant Flow:   Overall Study
    Varenicline  
STARTED     32  
COMPLETED     23  
NOT COMPLETED     9  
Withdrawal by Subject                 7  
Lost to Follow-up                 2  



  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
Varenicline Everyone on study received Varenicline (2 mg/day) daily for 12 weeks

Baseline Measures
    Varenicline  
Number of Participants  
[units: participants]
  32  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     32  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  42.9  ± 10.5  
Gender  
[units: participants]
 
Female     10  
Male     22  
Region of Enrollment  
[units: participants]
 
United States     32  
cigarettes per day [1]
[units: cigarettes per day]
Mean ± Standard Deviation
  20.3  ± 5.0  
Duration of alcohol recovery [2]
[units: months]
Median ( Full Range )
  29  
  ( 6 to 217 )  
[1] Self reported average number of cigarettes smoked per day over the preceding 6 months prior to study enrollment.
[2] Self reported number of months in recovery from alcohol dependence prior to study enrollment.



  Outcome Measures

1.  Primary:   Biochemically Confirmed Abstinence From Smoking   [ Time Frame: 12 weeks from start of medication ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: J Taylor Hays. MD
Organization: Mayo Clinic
phone: 507-266-1944
e-mail: nicotineresearch@mayo.edu


Publications of Results:

Responsible Party: James Taylor Hays, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01092702     History of Changes
Other Study ID Numbers: 08-00672
Study First Received: March 19, 2010
Results First Received: October 28, 2010
Last Updated: April 15, 2011
Health Authority: United States: Institutional Review Board