Smoking Cessation Program in the Construction Sector

NCT06098144 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 20230549
• Study Type: interventional
• Target: 608
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking Cessation; Tobacco Use Cessation; Tobacco Smoking

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Program's Implementation- Acceptability Measured by Likert Scale

  Up to 4 years

• Program's Implementation- Feasibility Measured by Likert Scale

  Up to 4 years

• Program's Implementation- Sustainability Measured by Likert Scale

  Up to 4 years

Study Arms (6)

Phase 1 Group A: Tobacco Quit-line (TQL) Group

EXPERIMENTAL

Participants will be referred to the TQL and will be followed up for up to 12 months.

Behavioral: Tobacco Quit-line

Phase 1 Group B: Brief Behavioral Counseling Group

EXPERIMENTAL

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.

Drug: Nicorette; Behavioral: Tobacco Quit-line; Behavioral: Brief Behavioral Counseling

Phase 2 Group A: Second Tobacco Quit-line (TQL) Group

EXPERIMENTAL

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

Phase 2 Group B: Second Brief Behavioral Counseling Group

EXPERIMENTAL

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.

Drug: Nicorette; Behavioral: Tobacco Quit-line; Behavioral: Brief Behavioral Counseling

Phase 2 Group A + C: TQL and Intensive Behavioral Counseling Group

EXPERIMENTAL

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.

Drug: Nicorette; Behavioral: Tobacco Quit-line; Behavioral: Intensive Behavioral Counseling

Phase 2 Group B + C: Brief Counseling and Intensive Behavioral Counseling Group

EXPERIMENTAL

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.

Drug: Nicorette; Behavioral: Tobacco Quit-line; Behavioral: Brief Behavioral Counseling; Behavioral: Intensive Behavioral Counseling

Interventions

Nicorette DRUG

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.

Phase 1 Group B: Brief Behavioral Counseling Group; Phase 2 Group A + C: TQL and Intensive Behavioral Counseling Group; Phase 2 Group B + C: Brief Counseling and Intensive Behavioral Counseling Group; Phase 2 Group B: Second Brief Behavioral Counseling Group

Tobacco Quit-line BEHAVIORAL

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.

Phase 1 Group A: Tobacco Quit-line (TQL) Group; Phase 1 Group B: Brief Behavioral Counseling Group; Phase 2 Group A + C: TQL and Intensive Behavioral Counseling Group; Phase 2 Group A: Second Tobacco Quit-line (TQL) Group; Phase 2 Group B + C: Brief Counseling and Intensive Behavioral Counseling Group; Phase 2 Group B: Second Brief Behavioral Counseling Group

Brief Behavioral Counseling BEHAVIORAL

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.

Phase 1 Group B: Brief Behavioral Counseling Group; Phase 2 Group B + C: Brief Counseling and Intensive Behavioral Counseling Group; Phase 2 Group B: Second Brief Behavioral Counseling Group

Intensive Behavioral Counseling BEHAVIORAL

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.

Phase 2 Group A + C: TQL and Intensive Behavioral Counseling Group; Phase 2 Group B + C: Brief Counseling and Intensive Behavioral Counseling Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Safety Managers:
• \- Current cigarette smoker

Sponsors & Collaborators

• University of Miami: lead
• Florida Department of Health: collaborator

Study Sites (1)

Don Soffer Clinical Research Center

Miami, Florida, 33136, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 40489501 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Cessation; Tobacco Smoking

Interventions

Nicotine Chewing Gum

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking; Tobacco Use

Intervention Hierarchy (Ancestors)

Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Tobacco Use Cessation Devices; Therapeutics; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Taghrid Asfar, MD

  tasfar@miami.edu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Taghrid Asfar, MD

CONTACT

305-243-3826; tasfar@miami.edu

Roxana de Dios Despaux, MPH

CONTACT

786-317-7927; rad317@miami.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Cluster-randomized clinical trial

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 24, 2023
• Study Start: April 10, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)