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Varenicline In-Patient Study (VIP)

This study is currently recruiting participants.
Verified May 2012 by University of California, San Francisco
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Jodi Prochaska, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01413516
First received: August 3, 2011
Last updated: May 15, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Moffitt-Long, 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, and will refer any patients without insurance to the free cessation clinic at SFGH.


Condition Intervention Phase
Smoking Cessation
 Behavioral: Smoking counseling
Drug: Placebo
Drug: Varenicline
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Two-Part Pilot Study of Dosing, Safety and Efficacy of Varenicline Initiated During an Acute Smoke-free Hospitalization and Continued Post-Hospitalization

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 80
Study Start Date: August 2011
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
 Behavioral: Smoking counseling
Counseling sessions provided by a trained smoking counselor along with placebo during 1st day of study
Drug: Placebo
Sugar pill without any active medication
Other Name: sugar pill (control)
Active Comparator: Experimental: Varenicline

Smoking counseling, Varenicline: Experimental

Interventions:

  • Behavioral: smoking counseling
  • Drug: varenicline
 Behavioral: Smoking counseling
Counseling sessions provided by trained smoking counselor along with varenicline
Drug: Varenicline
Varenicline (an approved medication for smoking cessation)
Other Name: Chantix

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The sample, 40 women and 40 men, will be hospitalized patients recruited from the two medicine units (14L and 14MSHA), 10LS CVLT, and 12L Spine/Ortho at an academic medical center (Moffit Long Hospital) 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; 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413516

Contacts
Contact: Van Vu 415-476-7696

Locations
United States, California
Moffit Long Hospital Univerisity of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Van Vu     415-476-7696        
Principal Investigator: Judith Prochaska, PhD, MPH            
Sponsors and Collaborators
University of California, San Francisco
Pfizer
  More Information

No publications provided

Responsible Party: Jodi Prochaska, Associate Professor in Residence, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01413516     History of Changes
Other Study ID Numbers: VIP
Study First Received: August 3, 2011
Last Updated: May 15, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Varenicline
Placebo
In-Patient

Additional relevant MeSH terms:
Smoking
Habits
Varenicline
Nicotinic Agonists
Cholinergic Agonists
 Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013