Varenicline In-Patient Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-10-31

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).

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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.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo Control

Smoking cessation counseling with placebo comparator

Group Type PLACEBO_COMPARATOR

Smoking cessation counseling

Intervention Type BEHAVIORAL

Counseling sessions provided by a trained smoking counselor

Placebo

Intervention Type DRUG

Sugar pill without any active medication

Experimental: Varenicline

Smoking cessation counseling with varenicline

Group Type ACTIVE_COMPARATOR

Smoking cessation counseling

Intervention Type BEHAVIORAL

Counseling sessions provided by a trained smoking counselor

Varenicline

Intervention Type DRUG

Varenicline (an approved medication for smoking cessation)

Interventions

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Smoking cessation counseling

Counseling sessions provided by a trained smoking counselor

Intervention Type BEHAVIORAL

Placebo

Sugar pill without any active medication

Intervention Type DRUG

Varenicline

Varenicline (an approved medication for smoking cessation)

Intervention Type DRUG

Other Intervention Names

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sugar pill (control) Chantix

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes