Smoking Cessation Program in the Construction Sector

Expanding the Role of the Safety Manager to Implement a Workplace Smoking Cessation Program in the Construction Sector

The main objective of this study is to identify the optimal adaptive smoking cessation program for the construction sector in terms of effectiveness, cost-effectiveness, and potential implementation.

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation; Tobacco Smoking; Tobacco Use Cessation
• Intervention / Treatment: Behavioral: Tobacco Quit-line; Behavioral: Brief Behavioral Counseling; Behavioral: Intensive Behavioral Counseling; Drug: Nicorette

• Study Type: Interventional
• Enrollment (Estimated): 608
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Taghrid Asfar, MD; Phone Number: 305-243-3826; Email: tasfar@miami.edu
• Study Contact Backup: Name: Roxana De Dios Despaux, MPH; Phone Number: 786-317-7927; Email: rad317@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • Don Soffer Clinical Research Center
      • Principal Investigator: Taghrid Asfar, MD
      • Contact: Roxana De Dios Despaux, MPH; Phone Number: 786-317-7927; Email: rad317@miami.edu
      • Contact: Daniela Avendano, MS; Phone Number: 305-915-0061; Email: dxa1356@miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Company leaders:

• ≥ 18 years
• Involved in decision making
• Willing to participate in the implementation development and evaluation

Safety Managers:

- ≥ 18 years Self-identified as a safety manager or superintendent Have no plans to leave the company in the next year Speak either English or Spanish Non-cigarette smoker Willing to receive training in smoking cessation treatment Willing to deliver the smoking cessation treatment to workers

Construction Workers:

• Be a construction worker
• ≥ 18 years
• Have smoked on average 5 or more cigarettes daily for the past year
• Willing to make a serious quit attempt in the next 30 days
• Willing to receive treatment from the Florida Tobacco Quitline.
• Planning to stay in the company for the next 6 months
• Own a telephone and plan to keep it active for the next 12 months

Exclusion Criteria:

Safety Managers:

- Current cigarette smoker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1 Group A: Tobacco Quit-line (TQL) Group; Participants will be referred to the TQL and will be followed up for up to 12 months.	Behavioral: Tobacco Quit-line; The TQL is free, and the TQL counselor will provide three phone counseling sessions lasting approximately 15 minutes to devise a specific plan to quit smoking and arrange the delivery of 4 to 12 weeks of NRT based on need. Participants will be advised to request nicotine gums instead of patches to accommodate their job circumstances.
Experimental: Phase 1 Group B: Brief Behavioral Counseling Group; Participants will receive one brief behavioral counseling session and two phone call follow-ups, then be followed up for 12 months. Besides the counseling session, they will be provided with Nicotine Replacement Therapy (NRT) and a referral to the TQL. For the NRT, participants will receive one box of Nicorette nicotine gums, 2 mg or 4 mg (depending on the number of cigarettes smoked), as well as 8 additional gums for a total of 168 gums during the counseling session. This amount is enough for 3 weeks. An additional 3-week supply will be provided at the second follow-up.	Behavioral: Tobacco Quit-line; The TQL is free, and the TQL counselor will provide three phone counseling sessions lasting approximately 15 minutes to devise a specific plan to quit smoking and arrange the delivery of 4 to 12 weeks of NRT based on need. Participants will be advised to request nicotine gums instead of patches to accommodate their job circumstances.; Behavioral: Brief Behavioral Counseling; The counseling session will discuss preparing to quit, coping with job-related stress, getting social support, the "5A's" for preventing relapse (Avoid, Alter, Alternatives, Anticipate, and Active), proper use of NRT, and last approximately 30 minutes.; Drug: Nicorette; Participants will receive a 6-week supply of nicotine replacement treatment (NRT). Based on participants' self-report on the number of cigarettes smoked, these are the possible dosages of NRT gum (2 mg and 4 mg). Participants should not smoke and use the nicotine gum at the same time. Nicotine gum should only be used when cravings for cigarettes arise and should not be treated like regular chewing gum. It is not to be constantly chewed NRT will be distributed based on the treatment condition.
Experimental: Phase 2 Group A: Second Tobacco Quit-line (TQL) Group; Participants from Group A who did not quit smoking at the 3-month follow-up may receive a second referral to the TQL and will be followed up for up to 12 months.	Behavioral: Tobacco Quit-line; The TQL is free, and the TQL counselor will provide three phone counseling sessions lasting approximately 15 minutes to devise a specific plan to quit smoking and arrange the delivery of 4 to 12 weeks of NRT based on need. Participants will be advised to request nicotine gums instead of patches to accommodate their job circumstances.
Experimental: Phase 2 Group B: Second Brief Behavioral Counseling Group; Participants from Group B who did not quit smoking at the 3-month follow-up may receive a second brief behavioral counseling session and two phone call follow-ups, then be followed up for 12 months. Besides the counseling session, they will be provided with Nicotine Replacement Therapy (NRT) and a second referral to the TQL. For the NRT, participants will receive one box of Nicorette nicotine gums, 2 mg or 4 mg (depending on the number of cigarettes smoked), as well as 8 additional gums for a total of 168 gums during the counseling session. This amount is enough for 3 weeks. An additional 3-week supply is provided at the second follow-up.	Behavioral: Tobacco Quit-line; The TQL is free, and the TQL counselor will provide three phone counseling sessions lasting approximately 15 minutes to devise a specific plan to quit smoking and arrange the delivery of 4 to 12 weeks of NRT based on need. Participants will be advised to request nicotine gums instead of patches to accommodate their job circumstances.; Behavioral: Brief Behavioral Counseling; The counseling session will discuss preparing to quit, coping with job-related stress, getting social support, the "5A's" for preventing relapse (Avoid, Alter, Alternatives, Anticipate, and Active), proper use of NRT, and last approximately 30 minutes.; Drug: Nicorette; Participants will receive a 6-week supply of nicotine replacement treatment (NRT). Based on participants' self-report on the number of cigarettes smoked, these are the possible dosages of NRT gum (2 mg and 4 mg). Participants should not smoke and use the nicotine gum at the same time. Nicotine gum should only be used when cravings for cigarettes arise and should not be treated like regular chewing gum. It is not to be constantly chewed NRT will be distributed based on the treatment condition.
Experimental: Phase 2 Group A + C: TQL and Intensive Behavioral Counseling Group; Participants from Phase 1 Group A who did not quit smoking at the 3-month follow-up may receive four behavioral counseling sessions, two phone-call follow-ups, and Nicotine Replacement Therapy (NRT) and be followed up for 12 months. For the NRT, participants will receive one box of Nicorette nicotine gums, 2 mg or 4 mg (depending on the number of cigarettes smoked), as well as 8 additional gums for a total of 168 gums during the first counseling session. This amount is enough for 3 weeks. An additional 3-week supply is provided at the fourth session.	Behavioral: Tobacco Quit-line; The TQL is free, and the TQL counselor will provide three phone counseling sessions lasting approximately 15 minutes to devise a specific plan to quit smoking and arrange the delivery of 4 to 12 weeks of NRT based on need. Participants will be advised to request nicotine gums instead of patches to accommodate their job circumstances.; Behavioral: Intensive Behavioral Counseling; Participants will receive four weekly counseling sessions which include information about how to quit, challenges, and short and long-term relapse prevention. Each session will last approximately 20 minutes.; Drug: Nicorette; Participants will receive a 6-week supply of nicotine replacement treatment (NRT). Based on participants' self-report on the number of cigarettes smoked, these are the possible dosages of NRT gum (2 mg and 4 mg). Participants should not smoke and use the nicotine gum at the same time. Nicotine gum should only be used when cravings for cigarettes arise and should not be treated like regular chewing gum. It is not to be constantly chewed NRT will be distributed based on the treatment condition.
Experimental: Phase 2 Group B + C: Brief Counseling and Intensive Behavioral Counseling Group; Participants from Phase 1 Group B who did not quit smoking at the 3-month follow-up may receive four behavioral counseling sessions, two phone-call follow-ups, and Nicotine Replacement Therapy (NRT) and be followed up for 12 months. For the NRT, participants will receive one box of Nicorette nicotine gums, 2 mg or 4 mg (depending on the number of cigarettes smoked), as well as 8 additional gums for a total of 168 gums during the first counseling session. This amount is enough for 3 weeks. An additional 3-week supply is provided at the fourth session.	Behavioral: Tobacco Quit-line; The TQL is free, and the TQL counselor will provide three phone counseling sessions lasting approximately 15 minutes to devise a specific plan to quit smoking and arrange the delivery of 4 to 12 weeks of NRT based on need. Participants will be advised to request nicotine gums instead of patches to accommodate their job circumstances.; Behavioral: Brief Behavioral Counseling; The counseling session will discuss preparing to quit, coping with job-related stress, getting social support, the "5A's" for preventing relapse (Avoid, Alter, Alternatives, Anticipate, and Active), proper use of NRT, and last approximately 30 minutes.; Behavioral: Intensive Behavioral Counseling; Participants will receive four weekly counseling sessions which include information about how to quit, challenges, and short and long-term relapse prevention. Each session will last approximately 20 minutes.; Drug: Nicorette; Participants will receive a 6-week supply of nicotine replacement treatment (NRT). Based on participants' self-report on the number of cigarettes smoked, these are the possible dosages of NRT gum (2 mg and 4 mg). Participants should not smoke and use the nicotine gum at the same time. Nicotine gum should only be used when cravings for cigarettes arise and should not be treated like regular chewing gum. It is not to be constantly chewed NRT will be distributed based on the treatment condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Program Effectiveness Measure in Percentage	Will be collected as the difference in percentage of participants who quit smoking at the 12-month follow-up assessment between the three treatment groups.	Up to 4 years
Program Cost-Effectiveness Measured by Number of U.S Dollars	Will be measured as the difference in the number of U.S. dollars between the three programs.	Up to 4 years
Program Cost-Effectiveness Measured by Quality Adjusted Life Years	Will be measured by quality-adjusted life years defined as the difference in the number of years lived in perfect health between the three programs.	Up to 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Program's Implementation- Acceptability Measured by Likert Scale	Using the Acceptability of Intervention Measure, acceptability will be scored on a 5-point Likert scale, with higher scores indicating greater acceptability.	Up to 4 years
Program's Implementation- Feasibility Measured by Likert Scale	Using the Feasibility of Intervention Measure, feasibility will be scored on a 5-point Likert scale, with higher scores indicating greater feasibility.	Up to 4 years
Program's Implementation- Sustainability Measured by Likert Scale	Using the Intervention Sustainability Assessment Tool, sustainability will be scored on a 7-point Likert scale, with higher scores indicating greater sustainability.	Up to 4 years

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Florida Department of Health
• Investigators: Principal Investigator: Taghrid Asfar, MD, tasfar@miami.edu

Publications and helpful links

General Publications

• Asfar T, Lee DJ, Salloum RG, LeLaurin JH, Kobetz E, Pradhananga N, De Dios Despaux RA, McCollister KE, Oluwole O, Corbin L, Laine J, Bursac Z. Empowering safety managers to champion the implementation of smoking cessation services in the construction industry: Protocol for a sequential multiple assignment randomized trial. PLoS One. 2025 Jun 9;20(6):e0324717. doi: 10.1371/journal.pone.0324717. eCollection 2025.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Smoking; Health Behavior; Tobacco Use; Smoking Cessation; Tobacco Smoking; Tobacco Use Cessation; Therapeutics; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Carbohydrates; Polymers; Macromolecular Substances; Polysaccharides; Biopolymers; Plant Gums; Candy; Chewing Gum; Tobacco Use Cessation Devices; Nicotine Chewing Gum
• Other Study ID Numbers: 20230549

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No