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Recruiting NCT06098144

Smoking Cessation Program in the Construction Sector

Phase IV Interventional Smoking Cessation Tobacco Use Cessation Tobacco Smoking

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nicorette, Tobacco Quit-line, Brief Behavioral Counseling, Intensive Behavioral Counseling.
Who it may be relevant to
Registry conditions: Smoking Cessation, Tobacco Use Cessation, Tobacco Smoking. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Program Effectiveness Measure in Percentage [Time frame: Up to 4 years]
  • Program Cost-Effectiveness Measured by Number of U.S Dollars [Time frame: Up to 4 years]
  • Program Cost-Effectiveness Measured by Quality Adjusted Life Years [Time frame: Up to 4 years]
Secondary outcome measures (3)
  • Program's Implementation- Acceptability Measured by Likert Scale [Time frame: Up to 4 years]
  • Program's Implementation- Feasibility Measured by Likert Scale [Time frame: Up to 4 years]
  • Program's Implementation- Sustainability Measured by Likert Scale [Time frame: Up to 4 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Don Soffer Clinical Research Center — Miami

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. eCo PMID 40489501

Identifiers

NCT: NCT06098144 · 20230549

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗