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Varenicline In-Patient Study (VIP)

This study is currently recruiting participants. (see Contacts and Locations)
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
  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 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.


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:


Further study details as provided by Stanford University:

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: December 2014 (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 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Nicole Anzai 510-204-3312

Locations
United States, California
Stanford Hospital and Clinics Recruiting
Stanford, California, United States, 94305
Contact: Nicole Anzai, BS    510-204-3312    tobaccotx@stanford.edu   
Principal Investigator: Judith Prochaska, PhD, MPH         
Sponsors and Collaborators
Stanford University
Pfizer
  More Information

No publications provided

Responsible Party: Judith Prochaska, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01413516     History of Changes
Other Study ID Numbers: VIP
Study First Received: August 3, 2011
Last Updated: December 12, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Stanford University:
Varenicline
Placebo
Inpatient

Additional relevant MeSH terms:
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 August 26, 2014