Varenicline In-Patient Study

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Smoking cessation counseling
* Drug: Placebo
* Drug: Varenicline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Control<br>Smoking cessation counseling with placebo comparator | Behavioral: Smoking cessation counseling<br>* Counseling sessions provided by a trained smoking counselor<br>Drug: Placebo<br>* Sugar pill without any active medication<br>* Other names: sugar pill (control);|
| Active Comparator: Experimental: Varenicline<br>Smoking cessation counseling with varenicline | Behavioral: Smoking cessation counseling<br>* Counseling sessions provided by a trained smoking counselor<br>Drug: Varenicline<br>* Varenicline (an approved medication for smoking cessation)<br>* Other names: Chantix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7 Day Point Prevalence Abstinence From All Forms of Tobacco | 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. | 4 weeks after beginning study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inpatient, Placebo, Varenicline