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Varenicline In-Patient Study (VIP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01413516
First Posted: August 10, 2011
Last Update Posted: July 2, 2017
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.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Judith Prochaska, Stanford University
August 3, 2011
August 10, 2011
February 25, 2016
December 30, 2016
July 2, 2017
August 2011
October 2014   (Final data collection date for primary outcome measure)
7 Day Point Prevalence Abstinence From All Forms of Tobacco [ Time Frame: 4 weeks after beginning study ]
Self report of being quit for 7 continuous days at the time of the 4-week follow-up survey confirmed by saliva cotinine or urine anabasine verification.
Quit rate (those who have quit smoking and have not smoked in the 7 days prior to the assessment date) for those in the varenicline group versus the placebo group [ Time Frame: 4 weeks after beginning study ]
Complete list of historical versions of study NCT01413516 on ClinicalTrials.gov Archive Site
  • Nicotine Withdrawal and Urges to Smoke [ Time Frame: 4 weeks ]
  • Medication Compliance Rate [ Time Frame: 4 weeks after initial assessment ]
    This will be measured using two biomarkers collected from blood, urine, and saliva samples.
  • Time to First Cigarette Post-hospitalization [ Time Frame: 4 weeks ]
  • Stage of Change [ Time Frame: 4 weeks ]
  • Adverse Events [ Time Frame: 4 weeks ]
    Adverse effects assessed by structured checklist with choices of not present, mild, moderate, severe graded by FDA toxicity criteria.
  • Number of participants who report fewer smoking withdrawal symptoms and urges [ Time Frame: 4 weeks ]
  • Medication Compliance Rate [ Time Frame: 4 weeks after initial assessment ]
    This will be measured using two biomarkers collected from blood, urine, and saliva samples.
  • Time to first cigarette in experimental group versus placebo [ Time Frame: 4 weeks ]
  • Stage of change (determined by Prochaska and diClimente's model) [ Time Frame: 4 weeks ]
  • Number of reported adverse events for those in the varenicline group versus the placebo group [ Time Frame: 4 weeks ]
    Adverse effects assessed by structured checklist with choices of not present, mild, moderate, severe graded by FDA toxicity criteria.
Not Provided
Not Provided
 
Varenicline In-Patient Study
A Two-Part Pilot Study of Dosing, Safety and Efficacy of Varenicline Initiated During an Acute Smoke-free Hospitalization and Continued Post-Hospitalization
This Investigator Initiated Research Award (IIR Award #WS981308) is a two-part pilot study that aims to examine acceptability and feasibility of varenicline use during an acute (72-hr) smoke-free hospitalization (Part 1) and 4-weeks post-hospitalization (Part 2).
The sample will be hospitalized patients smoking at least 10 cigarettes/day prior to hospitalization. Intention to quit smoking will not be required for study participation. Using a double-blinded, placebo-controlled, randomized design, participants will receive varenicline (0.5 mg BID as tolerated) or placebo during their hospitalization (Part 1) and will continue their study medication (placebo or active drug) for 4 weeks post-hospitalization (Part 2). Abstinence status will be examined at 4 weeks post-hospitalization.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Smoking Cessation
  • Behavioral: Smoking cessation counseling
    Counseling sessions provided by a trained smoking counselor
  • Drug: Placebo
    Sugar pill without any active medication
    Other Name: sugar pill (control)
  • Drug: Varenicline
    Varenicline (an approved medication for smoking cessation)
    Other Name: Chantix
  • Placebo Comparator: Placebo Control
    Smoking cessation counseling with placebo comparator
    Interventions:
    • Behavioral: Smoking cessation counseling
    • Drug: Placebo
  • Active Comparator: Experimental: Varenicline
    Smoking cessation counseling with varenicline
    Interventions:
    • Behavioral: Smoking cessation counseling
    • Drug: Varenicline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
October 2014
October 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • The sample, 40 women and 40 men, will be hospitalized patients recruited from Stanford Hospital and Clinics who report smoking at least 10 cigarettes per day prior to hospitalization, have confirmed tobacco use by cotinine testing, and an expected hospitalization of at least 3 days duration from the date of study enrollment. Intention to quit smoking will not be required for study participation.

Exclusion Criteria:

- Study exclusion criteria are: dementia or other brain injury precluding ability to participate; Alzheimer's Disease; Parkinson's Disease; Huntington's Disease; meningitis; seizure disorder of a sustained nature; delirium; brain surgery; drug and/or alcohol dependence; suicidal ideation; end-stage renal disease (i.e., on dialysis); hypertensive crisis; stroke; myocardial infarction (MI) with severe cardiac damage; pregnancy or breastfeeding; non-English speaking; complete homelessness; or currently engaged in tobacco treatment. Study staff will consult with clinical staff prior to approach for study enrollment. In cases of severe renal impairment (estimated creatinine clearance <30 mL/min), medical staff will consult with participants' physician to assess the appropriateness for study enrollment.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01413516
VIP
Yes
Not Provided
Plan to Share IPD: Undecided
Judith Prochaska, Stanford University
Stanford University
Pfizer
Principal Investigator: Judith J Prochaska, PhD, MPH Stanford University
Stanford University
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP