Varenicline In-Patient Study

Not Recruiting

Trial ID: NCT01413516


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).

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

Stanford Investigator(s)

Judith Prochaska

Senior Associate Vice Provost, Clinical Research Governance and Professor of Medicine (Stanford Prevention Research Center)


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.


drug: Placebo

drug: Varenicline

behavioral: Smoking cessation counseling

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305