NCT06098144

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 608 (estimated)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2024-04-10
• Primary completion: 2027-02-28
• Completion: 2027-02-28
• First posted: 2023-10-24
• Last updated: 2025-09-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study