Varenicline for Smoking Cessation in Heavy Drinking Smokers

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stephanie O'Malley, Yale University
ClinicalTrials.gov Identifier:
NCT00860028
First received: March 10, 2009
Last updated: January 28, 2013
Last verified: January 2013
Results First Received: January 3, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Nicotine Dependence
Smoking
Heavy Drinking
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
Outpatient research clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to randomization, inclusion and exclusion criteria were assessed. Reasons for exclusion included health problems, not meeting drinking/smoking criteria, other drug use, and depression requiring treatment.

Reporting Groups
  Description
Varenicline Pretreatment/Varenicline Pretreatment Arm 1 (Experimental) = 3 weeks varenicline (Chantix) 1 mg oral tablet twice per day pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment.
Placebo Pretreatment/Varenicline Treatment Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date.

Participant Flow for 2 periods

Period 1:   Placebo Controlled Pretreatment Period
    Varenicline Pretreatment/Varenicline Pretreatment     Placebo Pretreatment/Varenicline Treatment  
STARTED     15     15  
COMPLETED     13     14  
NOT COMPLETED     2     1  
No longer interested in treatment                 2                 1  

Period 2:   Smoking Cessation Phase
    Varenicline Pretreatment/Varenicline Pretreatment     Placebo Pretreatment/Varenicline Treatment  
STARTED     13     14  
COMPLETED     13     12  
NOT COMPLETED     0     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.
No text entered.

Reporting Groups
  Description
Extended Varenicline Pretreatment Arm 1 (Experimental) = 3 weeks varenicline (Chantix) 1 mg oral tablet twice per day pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment
Short Varenicline Pretreatment (Placebo) Arm 2 (Experimental) = 3 weeks placebo pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment
Total Total of all reporting groups

Baseline Measures
    Extended Varenicline Pretreatment     Short Varenicline Pretreatment (Placebo)     Total  
Number of Participants  
[units: participants]
  15     15     30  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     15     15     30  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  42.87  ± 8.52     43.47  ± 7.99     43.17  ± 8.12  
Gender  
[units: participants]
     
Female     7     7     14  
Male     8     8     16  
Region of Enrollment  
[units: participants]
     
United States     15     15     30  



  Outcome Measures
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1.  Primary:   Number of Participants Reporting Continuous Smoking Abstinence in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions.   [ Time Frame: Last 4 weeks of treatment ]

2.  Primary:   Mean Percentage of Heavy Drinking Days Comparing Participants in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions   [ Time Frame: First 3 weeks (pretreatment) ]

3.  Secondary:   Number of Participants Who Reported an Adverse Event in the Varenicline Pretreatment Versus Placebo Pretreatment Conditions   [ Time Frame: First 3 weeks (pretreatment) ]


  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: Dr. Stephanie O'Malley
Organization: Yale School of Medicine
phone: 203-974-7590
e-mail: stephanie.omalley@yale.edu


Publications of Results:

Responsible Party: Stephanie O'Malley, Yale University
ClinicalTrials.gov Identifier: NCT00860028     History of Changes
Other Study ID Numbers: NIAAA-O'Malley-P50AA15632-2009, P50AA015632
Study First Received: March 10, 2009
Results First Received: January 3, 2012
Last Updated: January 28, 2013
Health Authority: United States: Federal Government