Varenicline In-Patient Study



Status:Completed
Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:12/10/2017
Start Date:August 2011
End Date:October 2014

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A Two-Part Pilot Study of Dosing, Safety and Efficacy of Varenicline Initiated During an Acute Smoke-free Hospitalization and Continued Post-Hospitalization

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 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.

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.
We found this trial at
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Stanford, California 94305
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Stanford, CA
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