Smoking CessationPhase 4NCT02562521
A Smoking Cessation Intervention for Yale Dining Employees
A Phase 4 study testing Contingency management, Nicotine replacement therapy and Varenicline in people with Smoking Cessation, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Contingency management, Nicotine replacement therapy and Varenicline
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Dec 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None specified, other than failure to meet all inclusion criteria listed above.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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
- Smoking Cessation
- Being tested
- Contingency management, Nicotine replacement therapy, Varenicline, Additional behavioral support
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency managementBehavioural
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 therapyDrug
Participants have the option of using nicotine patch in combination with nicotine gum or lozenge
VareniclineDrug
Individuals who do not respond initially to Nicotine Replacement Therapy will be offered varenicline as an alternative
Additional behavioral supportBehavioural
Also called telephone quit lines and mobile applications
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 weeks
Secondary outcomes (7)
Number of Participants Who Quit Smoking at 2 Months
Smoking cessation is operationally defined as successfully quitting smoking at 2 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million).
Measured: Month 2
Number of Participants Who Quit Smoking at 3 Months
Smoking cessation is operationally defined as successfully quitting smoking at 3 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million).
Measured: Month 3
Number of People Who Quit Smoking at 4 Months
Smoking cessation is operationally defined as successfully quitting smoking at 4 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million).
Measured: Month 4
Number of People Who Quit Smoking at 5 Months
Smoking cessation is operationally defined as successfully quitting smoking at 5 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million).
Measured: Month 5
Number of People Who Quit Smoking at 6 Months
Smoking cessation is operationally defined as successfully quitting smoking at 6 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million).
Measured: Month 6
Wisconsin Predicting Patient's Relapse Questionnaire
Items from the Wisconsin Predicting Patient's Relapse questionnaire (WI-PREPARE) will be administered. This is a brief scale comprised of 7 items that assesses proneness to smoking relapse. Items are summed to create a total score. Total range=1-13 with higher scores indicating greater likelihood of smoking relapse.
Measured: Baseline
Wisconsin Predicting Patient's Relapse Questionnaire
Items from the Wisconsin Predicting Patient's Relapse questionnaire (WI-PREPARE) will be administered. This is a brief scale comprised of 7 items that assesses proneness to smoking relapse. Items are summed to create a total score. Total range=1-13 with higher scores indicating greater likelihood of smoking relapse.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie O'Malley, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562521
- Sponsor's protocol ID
- 1411014980
- Status last verified
- Mar 2018
- First submitted
- 25 Sep 2015
- Last updated
- 9 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Smoking Cessation Intervention for Yale Dining Employees
- ClinicalTrials.gov ID
- NCT02562521
- Acronym / sponsor ID
- 1411014980
- Conditions
- Smoking Cessation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 29 Sep 2015 (estimated)
- Results
- Posted 9 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoking Cessation Treatment | Experimental | Behavioral: Contingency management, Drug: Nicotine replacement therapy, Drug: Varenicline, Behavioral: Additional behavioral supportThe 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. |
| Delayed Treatment Control | No intervention | –Participants in this arm will be offered the Smoking Cessation Treatment 6 weeks later |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- None specified, other than failure to meet all inclusion criteria listed above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contingency managementParticipants in the intervention group will receive a tailored intervention that utilizes contingency management in which they receive monetary rewards for reducing or quitting smoking. | Behavioural | Smoking Cessation Treatment |
| Nicotine replacement therapyParticipants have the option of using nicotine patch in combination with nicotine gum or lozenge | Drug | Smoking Cessation Treatment |
| VareniclineIndividuals who do not respond initially to Nicotine Replacement Therapy will be offered varenicline as an alternative | Drug | Smoking Cessation Treatment |
| Additional behavioral supportAlso: telephone quit lines and mobile applicationsBased on interest, participants can be referred to a telephone quitline or receive access to mobile text messaging programs or app based smoking cessation support | Behavioural | Smoking Cessation Treatment |
Primary outcome
Number of Participants With a Smoking Quit Attempt in the Prior Six Weeks
Time frame: 6 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.
Number of Participants Who Quit Smoking for at Least 24 Hours in the Prior Six Weeks
Time frame: 6 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.
7 secondary outcomes
Number of Participants Who Quit Smoking at 2 Months
Time frame: Month 2
Number of Participants Who Quit Smoking at 3 Months
Time frame: Month 3
Number of People Who Quit Smoking at 4 Months
Time frame: Month 4
Number of People Who Quit Smoking at 5 Months
Time frame: Month 5
Number of People Who Quit Smoking at 6 Months
Time frame: Month 6
Wisconsin Predicting Patient's Relapse Questionnaire
Time frame: Baseline
Wisconsin Predicting Patient's Relapse Questionnaire
Time frame: Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie O'Malley, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Contingency management, Nicotine replacement therapy and Varenicline in people with Smoking Cessation, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Smoking Quit Attempt in the Prior Six Weeks (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2018.