A Two-Part Pilot Study of Dosing, Safety and Efficacy of Varenicline Initiated During an Acute Smoke-free Hospitalization and Continued Post-Hospitalization
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- 7 Day Point Prevalence Abstinence From All Forms of Tobacco
Study Overview
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).
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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Placebo Control
Smoking cessation counseling with placebo comparator
Intervention: Smoking cessation counseling (Behavioral)
Placebo Control
Smoking cessation counseling with placebo comparator
Intervention: Placebo (Drug)
Experimental: Varenicline
Smoking cessation counseling with varenicline
Intervention: Smoking cessation counseling (Behavioral)
Experimental: Varenicline
Smoking cessation counseling with varenicline
Intervention: Varenicline (Drug)
Outcomes
Primary Outcomes
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 Outcomes
No secondary outcomes reported
Investigators
Judith Prochaska
Associate Professor
Stanford University