A Smoking Cessation Intervention for Yale Dining Employees

NCT02562521 | Completed Phase 4 Results

• 1 other identifier: 1411014980
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (2)

• Number of Participants With a Smoking Quit Attempt in the Prior Six Weeks

  A survey of dining hall employees will be used to determine the proportion of the dining hall employees who made a quit attempt in the prior six weeks in the treatment and delayed treatment control groups. Values present the proportion of dining hall employees who smoke who reported making a quit attempt.

  6 weeks

• Number of Participants Who Quit Smoking for at Least 24 Hours in the Prior Six Weeks

  A survey of dining hall employees will be used to determine the proportion of the dining hall employees who quit smoking for at least 24 hours in the prior six weeks in the treatment and delayed treatment control groups. Values present the number of individuals who report quitting successfully for at least 24 hours among individuals who reported smoking.

  6 weeks

Secondary Outcomes (7)

• Number of Participants Who Quit Smoking at 2 Months

  Month 2

• Number of Participants Who Quit Smoking at 3 Months

  Month 3

• Number of People Who Quit Smoking at 4 Months

  Month 4

• Number of People Who Quit Smoking at 5 Months

  Month 5

• Number of People Who Quit Smoking at 6 Months

  Month 6

Study Arms (2)

Smoking Cessation Treatment

EXPERIMENTAL

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.

Behavioral: Contingency management; Drug: Nicotine replacement therapy; Drug: Varenicline; Behavioral: Additional behavioral support

Delayed Treatment Control

NO INTERVENTION

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

Interventions

Contingency management 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.

Smoking Cessation Treatment

Nicotine replacement therapy DRUG

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

Smoking Cessation Treatment

Varenicline DRUG

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

Smoking Cessation Treatment

Additional behavioral support 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

Also known as: telephone quit lines and mobile applications

Smoking Cessation Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current smoker
• Interested in receiving treatment for quitting smoking.
• English speaker.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Replacement Therapy; Varenicline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Dr. Krysten Bold
• Organization: Yale University School of Medicine

krysten.bold@yale.edu

2039747603

Study Officials

• Stephanie O'Malley, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2015
• First Posted: September 29, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 9, 2018
• Results First Posted: April 9, 2018

Record last verified: 2018-03

Locations

US (1)