Effects of Varenicline on Cigarette Self Administration

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00731055
First received: August 6, 2008
Last updated: May 16, 2016
Last verified: April 2016
Results First Received: February 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Nicotine 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
Twenty-one participants were recruited in an urban hospital setting through advertisement in local newspapers and flyers and 16 particiopants were enrolled. Study was conducted at the NYS Psychiatric Institute

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
Study Participants This is a within-group study design, all participant who completed the study receive all 4 experimental treatments

Participant Flow:   Overall Study
    Study Participants  
STARTED     16 [1]
Received Placebo     16  
Received Varenicline 0.5 mg     16  
Received Varenicline 1.0 mg     16  
Received Varenicline 2.0 mg     16  
COMPLETED     16  
NOT COMPLETED     0  
[1] This is a within-subjects study design.



  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
Study Participants Each of study participants received one dose of study medication (varenicline 0mg, 0.5mg, 1mg, and 2 mg) before each of the experimental sessions at least 5 days apart.

Baseline Measures
    Study Participants  
Number of Participants  
[units: participants]
  16  
Age  
[units: years]
Mean (Full Range)
  36.5  
  (23 to 44)  
Gender  
[units: participants]
 
Female     4  
Male     12  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     10  
White     6  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     16  



  Outcome Measures

1.  Primary:   Cigarette Choice   [ Time Frame: During each of the four weekly 6-hour experimental sessions ]


  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: Dr. Adam Bisaga
Organization: New York State Psychiatric Institute
phone: 646-774-6155
e-mail: amb107@columbia.edu



Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00731055     History of Changes
Other Study ID Numbers: #5649/NIDA-17572-4
R01DA017572 ( US NIH Grant/Contract Award Number )
DPMCDA ( Other Identifier: NIDA )
Study First Received: August 6, 2008
Results First Received: February 19, 2014
Last Updated: May 16, 2016
Health Authority: United States: Food and Drug Administration
United States: Federal Government