Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit
NCT01308736
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Must smoke at least 10 cigarettes per day for past 6-months
- Must have a working cellular or land-line phone
- Must not be thinking of quitting in the next 30 days, but be interested in cutting
down- Must not regularly (more than 1x/month) use tobacco products other than
cigarettes
- Must not be currently receiving tobacco dependence treatment counseling
- Must not currently be taking varenicline, bupropion, nortriptyline, or any nicotine
preparations (gum, lozenge, patch, spray, inhaler)
- Must not have positive screen on SCID-I/NP Psychotic Screen
- Must have no contraindications to using varenicline, including pregnancy, as measured
by Medical History Form
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- New Brunswick, New Jersey
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit | |||
Official Title ICMJE | Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit | |||
Brief Summary | The investigators will randomize smokers to receive 1) Varenicline + smoking cessation/reduction counseling or 2) Placebo pill + smoking cessation/reduction counseling. Neither the participants nor the research therapists/evaluators will know to which condition (active or placebo pill) the participants have been assigned i.e., a double-blind study). The medication and weekly counseling will occur for 28 days. Participants will complete assessment measures just before the start of treatment (baseline), at the end-of-treatment, at 1-month, 3-month, and at 6-months to determine if there are differences in tobacco use between treatment groups. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Tobacco Use Disorder | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 73 | |||
Original Estimated Enrollment ICMJE | 60 | |||
Actual Study Completion Date ICMJE | February 2014 | |||
Actual Primary Completion Date | February 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 64 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01308736 | |||
Other Study ID Numbers ICMJE | WS777117 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Marc L. Steinberg, Ph.D., Rutgers University | |||
Study Sponsor ICMJE | Rutgers, The State University of New Jersey | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | Rutgers, The State University of New Jersey | |||
Verification Date | July 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |