Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit
|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.|
|ClinicalTrials.gov Identifier: NCT01308736|
Recruitment Status : Completed
First Posted : March 4, 2011
Results First Posted : July 23, 2015
Last Update Posted : July 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Use Disorder||Drug: Varenicline Drug: Placebo pill||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
|Active Comparator: varenicline||
Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
|Placebo Comparator: placebo pill||
Drug: Placebo pill
Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
- Cigarette Reduction [ Time Frame: At 6-month follow-up ]50% reduction in cigarettes per day as compared to baseline. Missing data are assumed to NOT have reduced.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01308736
|United States, New Jersey|
|Division of Addiction Psychiatry|
|New Brunswick, New Jersey, United States, 08901|
|Principal Investigator:||Marc L Steinberg, Ph.D.||University of Medicine and Dentistry of New Jersey|