Varenicline In-Patient Study (VIP)

This study is currently recruiting participants.
Verified December 2013 by Stanford University
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Judith Prochaska, Stanford University
ClinicalTrials.gov Identifier:
NCT01413516
First received: August 3, 2011
Last updated: December 12, 2013
Last verified: December 2013

August 3, 2011
December 12, 2013
August 2011
December 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01413516 on ClinicalTrials.gov Archive Site
  • Number of participants who report fewer smoking withdrawal symptoms and urges [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Medication compliance rate [ Time Frame: 4 weeks after initial assessment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Stage of change (determined by Prochaska and diClimente's model) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Number of reported adverse events for those in the varenicline group versus the placebo group [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Adverse effects assessed by structured checklist with choices of not present, mild, moderate, severe graded by FDA toxicity criteria.
Same as current
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, 40 women and 40 men, 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.

At the study end, the investigators will provide a letter to the study participant for his/her outpatient primary care provider that details their current smoking status and provides information on cessation medication options, including varenicline. It will be up to the primary care provider to manage the patients' treatment of tobacco dependence following study close. Of note, two-thirds of health insurance plans now cover the cost of varenicline so the cost to participants is likely to be minimal. Since participants will be recruited from Stanford Hospital, the investigators anticipate nearly all will have an appointment to see their primary care physician 4 to 5 weeks post-hospital discharge. Additionally, the investigators will refer participants to the state's toll-free quitline, whereby patients on Medi-Cal can obtain free cessation medication.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Smoking Cessation
  • Behavioral: Smoking counseling
    Counseling sessions provided by a trained smoking counselor along with placebo during 1st day of study
  • Behavioral: Smoking counseling
    Counseling sessions provided by trained smoking counselor along with varenicline
  • 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: Sugar pill without any active medication

    Smoking counseling, Placebo: Placebo comparator

    Interventions:

    • Behavior: smoking counseling
    • Drug: placebo (sugar pill without any active medication)
    Interventions:
    • Behavioral: Smoking counseling
    • Drug: Placebo
  • Active Comparator: Experimental: Varenicline

    Smoking counseling, Varenicline: Experimental

    Interventions:

    • Behavioral: smoking counseling
    • Drug: varenicline
    Interventions:
    • Behavioral: Smoking 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.
 
Recruiting
80
Not Provided
December 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.

Both
18 Years and older
Yes
Contact: Nicole Anzai 510-204-3312
United States
 
NCT01413516
VIP
Yes
Judith Prochaska, Stanford University
Stanford University
Pfizer
Not Provided
Stanford University
December 2013

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