A Smoking Cessation Intervention for Yale Dining Employees

NCT ID: NCT02562521

Last Updated: 2018-04-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-12-31

Brief Summary

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The purpose of this study is to evaluate a smoking cessation program for employees at the Yale University dining hall. Two pilot dining halls and six paired dining halls (3 test and 3 control sites) will be offered a contingency management/pharmacotherapy smoking cessation intervention at the work site.

Detailed Description

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The primary aim of this study is to test the effect of a smoking cessation intervention provided to Yale University dining hall employees on smoking quit rates and quit attempts at the end of six weeks of treatment. It is hypothesized that participants from the test site will have higher rates of smoking cessation and quit attempts compared to participants from the control site. In addition, this study will examine the number of participants who enroll in the smoking cessation program who successfully quit smoking at 6 months.

There will be 3 test sites and 3 control sites in this study (broken down into 3 pairs of test/control). Each test site will be matched to on a control site. Self-reported smoking status will be obtained for all participants in the test and control sites at 3 time points (baseline, 6 weeks and 6 months). The study start time for each pair will be delayed by 4-8 weeks for feasibility issues.

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

NONE

Study Groups

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Smoking Cessation Treatment

The intervention will consist of Contingency management (CM) in conjunction with effective first line pharmacotherapy (dual nicotine replacement therapy \[NRT\] or varenicline) and brief counseling to rapidly induce cessation and to maintain abstinence long term. Pharmacotherapy will be flexible. Participants will also be given the option of receiving additional behavioral support by being referred to the CT Quitline and using text or mobile phone apps for quitting.

Group Type EXPERIMENTAL

Contingency management

Intervention Type BEHAVIORAL

Participants in the intervention group will receive a tailored intervention that utilizes contingency management in which they receive monetary rewards for reducing or quitting smoking.

Nicotine replacement therapy

Intervention Type DRUG

Participants have the option of using nicotine patch in combination with nicotine gum or lozenge

Varenicline

Intervention Type DRUG

Individuals who do not respond initially to Nicotine Replacement Therapy will be offered varenicline as an alternative

Additional behavioral support

Intervention Type BEHAVIORAL

Based on interest, participants can be referred to a telephone quitline or receive access to mobile text messaging programs or app based smoking cessation support

Delayed Treatment Control

Participants in this arm will be offered the Smoking Cessation Treatment 6 weeks later

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Contingency management

Participants in the intervention group will receive a tailored intervention that utilizes contingency management in which they receive monetary rewards for reducing or quitting smoking.

Intervention Type BEHAVIORAL

Nicotine replacement therapy

Participants have the option of using nicotine patch in combination with nicotine gum or lozenge

Intervention Type DRUG

Varenicline

Individuals who do not respond initially to Nicotine Replacement Therapy will be offered varenicline as an alternative

Intervention Type DRUG

Additional behavioral support

Based on interest, participants can be referred to a telephone quitline or receive access to mobile text messaging programs or app based smoking cessation support

Intervention Type BEHAVIORAL

Other Intervention Names

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telephone quit lines and mobile applications

Eligibility Criteria

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Inclusion Criteria

* Current smoker
* Interested in receiving treatment for quitting smoking.
* Employed for more than 20 hours per week by one of the 7 residential college dining halls selected for inclusion in this study.
* English speaker.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephanie O'Malley, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale University

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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1411014980

Identifier Type: -

Identifier Source: org_study_id

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