Varenicline In-Patient Study

Phase 2

Completed

• Conditions: Smoking Cessation
• Interventions: Behavioral: Smoking cessation counseling; Drug: Placebo; Drug: Varenicline

• Registration Number: NCT01413516
• Lead Sponsor: Stanford University

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 Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-03
• Study First Submitted QC: 2011-08-08
• Study First Posted: 2011-08-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2016-02-25
• Results First Submitted QC: 2016-11-04
• Results First Posted: 2016-12-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Control	Placebo	Smoking cessation counseling with placebo comparator
Experimental: Varenicline	Smoking cessation counseling	Smoking cessation counseling with varenicline
Placebo Control	Smoking cessation counseling	Smoking cessation counseling with placebo comparator
Experimental: Varenicline	Varenicline	Smoking cessation counseling with varenicline

Primary Outcome Measures

Name	Time	Method
7 Day Point Prevalence Abstinence From All Forms of Tobacco	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.

Trial Locations

Locations (1)

Stanford Hospital and Clinics; 🇺🇸 Stanford, California, United States