Smoking Cessation Program in the Construction Sector

University of Miami

Status and phase: Enrolling; Phase 4

Conditions: Tobacco Use Cessation; Tobacco Smoking; Smoking Cessation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06098144

20230549

Details and patient eligibility

About

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.

Enrollment: 608 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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608 participants in 6 patient groups

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

Experimental group

Description:

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

Treatment:

Behavioral: Tobacco Quit-line

Phase 1 Group B: Brief Behavioral Counseling Group

Experimental group

Description:

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.

Treatment:

Drug: Nicorette

Behavioral: Brief Behavioral Counseling

Behavioral: Tobacco Quit-line

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

Experimental group

Description:

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.

Treatment:

Behavioral: Tobacco Quit-line

Phase 2 Group B: Second Brief Behavioral Counseling Group

Experimental group

Description:

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.

Treatment:

Drug: Nicorette

Behavioral: Brief Behavioral Counseling

Behavioral: Tobacco Quit-line

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

Experimental group

Description:

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.

Treatment:

Drug: Nicorette

Behavioral: Intensive Behavioral Counseling

Behavioral: Tobacco Quit-line

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

Experimental group

Description:

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.

Treatment:

Drug: Nicorette

Behavioral: Brief Behavioral Counseling

Behavioral: Intensive Behavioral Counseling

Behavioral: Tobacco Quit-line