Smoking Cessation Program in the Construction Sector

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06098144
• Other study ID #: 20230549
• Status: Recruiting
• Phase: Phase 4
• Start date: April 10, 2024
• Est. completion date: February 28, 2027

Study information

• Verified date: June 2024
• Source: University of Miami
• Contact: Taghrid Asfar, MD
• Phone: 305-243-3826
• Email: tasfar[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 608
• Est. completion date: February 28, 2027
• Est. primary completion date: February 28, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Company leaders:

• = 18 years

• Involved in decision making

• Willing to participate in the implementation development and evaluation

Safety Managers:

• = 18 years

• Be a safety manager

• No plans to leave the company within the next year

• Bilingual

• 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

• 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

Related Conditions & MeSH terms

• Smoking Cessation
• Tobacco Smoking
• Tobacco Use Cessation

Intervention

Drug:
• Nicoderm C-Q Gum
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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Don Soffer Clinical Research Center	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Florida Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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