Varenicline In-Patient Study (VIP)

• ClinicalTrials.gov Identifier: NCT01413516
• Recruitment Status: Completed
• First Posted: August 10, 2011
• Results First Posted: December 30, 2016
• Last Update Posted: December 8, 2017
• Sponsor: Stanford University
• Collaborator: Pfizer
• Information provided by (Responsible Party): Judith Prochaska, Stanford University

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Smoking Cessation	Behavioral: Smoking cessation counseling; Drug: Placebo; Drug: Varenicline	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 17 participants
• 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
• Study Start Date: August 2011
• Actual Primary Completion Date: October 2014
• Actual Study Completion Date: October 2014

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: VIP
• First Posted: August 10, 2011
• Results First Posted: December 30, 2016
• Last Update Posted: December 8, 2017
• Last Verified: November 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