Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00747643
First received: September 4, 2008
Last updated: November 21, 2013
Last verified: October 2011
Results First Received: July 27, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator)
Condition: Tobacco Dependence
Interventions: Drug: varenicline
Drug: placebo

  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
To achieve a sample size of 100 following attrition, we screened 573 smokers from the community and randomized 100 non-treatment seeking daily smokers to the two conditions. Smokers who were using other smoking cessation medications, or who had current mood or psychotic disorders were excluded.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants completed a baseline evaluation including screening for inclusion and exclusion criteria, a medical evaluation, basic metabolic panel and pregnancy test for females. Participants who met all of the inclusion criteria were scheduled for the assessment sessions.

Reporting Groups
  Description
Varenicline For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
Placebo Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.

Participant Flow:   Overall Study
    Varenicline     Placebo  
STARTED     82     81  
COMPLETED     46     54  
NOT COMPLETED     36     27  
Withdrawal by Subject                 36                 27  



  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
Varenicline For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
Placebo Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
Total Total of all reporting groups

Baseline Measures
    Varenicline     Placebo     Total  
Number of Participants  
[units: participants]
  46     54     100  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     46     54     100  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     18     21     39  
Male     28     33     61  
Region of Enrollment  
[units: participants]
     
United States     46     54     100  



  Outcome Measures
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1.  Primary:   Tonic Craving Score (QSU) Based on Self Reports   [ Time Frame: 3 weeks per participant ]

2.  Primary:   Cue-provoked Cravings   [ Time Frame: 3 weeks per participant ]

3.  Secondary:   Smoking Topography - Number of Puffs on a Cigarette   [ Time Frame: 3 weeks per participant ]

4.  Secondary:   A Measure of the Subjective Expected Value of a Cigarette   [ Time Frame: 3 weeks per participant ]


  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: Thomas H. Brandon, Ph.D.
Organization: H. Lee Moffitt Cancer Center and Research Institute
phone: 813-745-1750
e-mail: thomas.brandon@moffitt.org


No publications provided


Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00747643     History of Changes
Other Study ID Numbers: MCC-15444, 106842
Study First Received: September 4, 2008
Results First Received: July 27, 2011
Last Updated: November 21, 2013
Health Authority: United States: Institutional Review Board