Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit

NCT01308736

Last updated date
Study Location
Division of Addiction Psychiatry
New Brunswick, New Jersey, 08901, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tobacco Use Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-64 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Must smoke at least 10 cigarettes per day for past 6-months

- Must have a working cellular or land-line phone

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Tobacco Use DisorderVarenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit
NCT01308736
  1. New Brunswick, New Jersey
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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
  • Drug: 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: varenicline
    Intervention: Drug: Varenicline
  • Placebo Comparator: placebo pill
    Intervention: Drug: Placebo pill
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
 (submitted: July 22, 2015)
73
Original Estimated Enrollment  ICMJE
 (submitted: March 3, 2011)
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:

  • Must smoke at least 10 cigarettes per day for past 6-months
  • Must have a working cellular or land-line phone

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Principal Investigator:Marc L Steinberg, Ph.D.University of Medicine and Dentistry of New Jersey
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