Effects of Varenicline on Cigarette Self Administration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00731055
Recruitment Status : Completed
First Posted : August 8, 2008
Results First Posted : May 1, 2015
Last Update Posted : June 17, 2016
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Nicotine Dependence
Interventions: Drug: Varenicline
Drug: Placebo

  Participant Flow

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
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 
[1] This is a within-subjects study design.

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Full Range)
 (23 to 44) 
[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

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

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

Responsible Party: New York State Psychiatric Institute Identifier: NCT00731055     History of Changes
Other Study ID Numbers: #5649/NIDA-17572-4
R01DA017572 ( U.S. NIH Grant/Contract )
DPMCDA ( Other Identifier: NIDA )
First Submitted: August 6, 2008
First Posted: August 8, 2008
Results First Submitted: February 19, 2014
Results First Posted: May 1, 2015
Last Update Posted: June 17, 2016