Smoking CessationPhase 4NCT06098144
Smoking Cessation Program in the Construction Sector
A Phase 4 study testing Nicorette, Tobacco Quit-line and Brief Behavioral Counseling in people with Smoking Cessation and Tobacco Use Cessation, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Tobacco Use Cessation, Tobacco Smoking
- What is being tested?
- Nicorette, Tobacco Quit-line and Brief Behavioral Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 608 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2024to 28 Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- Safety Managers:
- Current cigarette smoker
Trial locations and contacts
1 site in 1 country.
United States1 site
Don Soffer Clinical Research Center
Miami, Florida, 33136
About this study
Official title: 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.
- Conditions
- Smoking Cessation, Tobacco Use Cessation, Tobacco Smoking
- Being tested
- Nicorette, Tobacco Quit-line, Brief Behavioral Counseling, Intensive Behavioral Counseling
- Medical subject headings
- Smoking Cessation, Tobacco Use Cessation, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicoretteDrug
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.
Tobacco Quit-lineBehavioural
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 CounselingBehavioural
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 CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Nicorette; Behavioral: Tobacco Quit-line; Behavioral: Brief Behavioral Counseling; Behavioral: Intensive Behavioral Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 4 years
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start10 Apr 2024
- Primary completion28 Jul 2027 (estimated)
- Study completion28 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-randomized clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 608 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Department of Health
- Responsible party
- Principal investigator, Taghrid Asfar, University of Miami
- Investigators
- Taghrid Asfar, MD, Principal investigator, tasfar@miami.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098144
- Sponsor's protocol ID
- 20230549
- Status last verified
- Aug 2026
- First submitted
- 18 Oct 2023
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40489501
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding the Role of the Safety Manager to Implement a Workplace Smoking Cessation Program in the Construction Sector
- ClinicalTrials.gov ID
- NCT06098144
- Acronym / sponsor ID
- 20230549
- Conditions
- Smoking Cessation, Tobacco Use Cessation, Tobacco Smoking
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 608 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Florida Department of Health
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 28 Jul 2027 (estimated)
- Study completion
- 28 Jul 2027 (estimated)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- Cluster-randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Group A: Tobacco Quit-line (TQL) Group | Experimental | Behavioral: Tobacco Quit-lineParticipants will be referred to the TQL and will be followed up for up to 12 months. |
| Phase 1 Group B: Brief Behavioral Counseling Group | Experimental | Drug: Nicorette, Behavioral: Tobacco Quit-line, Behavioral: Brief Behavioral CounselingParticipants 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. |
| Phase 2 Group A: Second Tobacco Quit-line (TQL) Group | Experimental | Behavioral: Tobacco Quit-lineParticipants 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. |
| Phase 2 Group B: Second Brief Behavioral Counseling Group | Experimental | Drug: Nicorette, Behavioral: Tobacco Quit-line, Behavioral: Brief Behavioral CounselingParticipants 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. |
| Phase 2 Group A + C: TQL and Intensive Behavioral Counseling Group | Experimental | Drug: Nicorette, Behavioral: Tobacco Quit-line, Behavioral: Intensive Behavioral CounselingParticipants 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. |
| Phase 2 Group B + C: Brief Counseling and Intensive Behavioral Counseling Group | Experimental | Drug: Nicorette, Behavioral: Tobacco Quit-line, Behavioral: Brief Behavioral Counseling, Behavioral: Intensive Behavioral CounselingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- ≥ 18 years
- Involved in decision making
- Willing to participate in the implementation development and evaluation
- ≥ 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
- Be a construction worker
Key exclusion criteria (2 listed)
- Current cigarette smoker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NicoretteParticipants 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. | Drug | 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-lineThe 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. | Behavioural | 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 CounselingThe 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. | Behavioural | 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 CounselingParticipants 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. | Behavioural | Phase 2 Group A + C: TQL and Intensive Behavioral Counseling Group, Phase 2 Group B + C: Brief Counseling and Intensive Behavioral Counseling Group |
Primary outcome
Program Effectiveness Measure in Percentage
Time frame: Up to 4 years
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.
Program Cost-Effectiveness Measured by Number of U.S Dollars
Time frame: Up to 4 years
Will be measured as the difference in the number of U.S. dollars between the three programs.
Program Cost-Effectiveness Measured by Quality Adjusted Life Years
Time frame: Up to 4 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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Derived from this study: PubMed 40489501Asfar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taghrid Asfar, MD principal investigator
tasfar@miami.edu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicorette, Tobacco Quit-line and Brief Behavioral Counseling in people with Smoking Cessation and Tobacco Use Cessation, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program Effectiveness Measure in Percentage (time frame: Up to 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06098144, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.