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Varenicline In-Patient Study (VIP)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Judith Prochaska, Stanford University
ClinicalTrials.gov Identifier:
NCT01413516
First received: August 3, 2011
Last updated: June 1, 2017
Last verified: June 2017
  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).

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Judith Prochaska, Stanford University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 17
Study Start Date: August 2011
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Control
Smoking cessation counseling with placebo comparator
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)
Active Comparator: Experimental: Varenicline
Smoking cessation counseling with varenicline
Behavioral: Smoking cessation counseling
Counseling sessions provided by a trained smoking counselor
Drug: Varenicline
Varenicline (an approved medication for smoking cessation)
Other Name: Chantix

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
United States, California
Stanford Hospital and Clinics
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Pfizer
Investigators
Principal Investigator: Judith J Prochaska, PhD, MPH Stanford University
  More Information

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
Results First Received: February 25, 2016
Last Updated: June 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Judith Prochaska, Stanford University:
Varenicline
Placebo
Inpatient

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

ClinicalTrials.gov processed this record on September 19, 2017