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Nicotine Replacement Therapy

Smoking Cessation Program for Quitting Smoking

Phase 4

Recruiting

Led By Taghrid Asfar, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Safety Managers: ≥ 18 years

Company leaders: ≥ 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

Study Summary

This trial will identify the best smoking cessation program to help people in the construction sector quit smoking, with an eye to effectiveness, costs, and implementation.

Who is the study for?

This trial is for construction sector leaders and safety managers over 18, involved in decision-making or willing to deliver smoking cessation treatment. It's also for workers who smoke at least 5 cigarettes daily, are ready to quit soon, and plan to stay with the company. Safety managers can't be current smokers.Check my eligibility

What is being tested?

The study tests different smoking cessation methods: intensive behavioral counseling, a tobacco quit-line service, brief counseling sessions, and Nicoderm C-Q Gum. The goal is to find the most effective program for helping construction workers quit smoking.See study design

What are the potential side effects?

Nicoderm C-Q Gum may cause mouth soreness, hiccups, nausea, or jaw discomfort. Behavioral interventions typically don't have physical side effects but can sometimes lead to temporary increased stress during the quitting process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am a company leader and I am 18 years old or older.

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I am ready to seriously try quitting smoking within the next 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Program Cost-Effectiveness Measured by Number of U.S Dollars

Program Cost-Effectiveness Measured by Quality Adjusted Life Years

Program Effectiveness Measure in Percentage

Secondary outcome measures

Program's Implementation- Acceptability Measured by Likert Scale

Program's Implementation- Feasibility Measured by Likert Scale

Program's Implementation- Sustainability Measured by Likert Scale

Trial Design

3Treatment groups

Experimental Treatment

Group I: Tobacco Quit-line (TQL) GroupExperimental Treatment1 Intervention

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

Group II: Intensive Behavioral Counseling GroupExperimental Treatment2 Interventions

Participants will receive four behavioral counseling sessions and be followed up for 12 months.

Group III: Brief Behavioral Counseling GroupExperimental Treatment3 Interventions

Participants will receive one brief behavioral counseling session and be followed up for 12 months.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

904 Previous Clinical Trials

409,622 Total Patients Enrolled

Florida Department of HealthOTHER_GOV

28 Previous Clinical Trials

12,395 Total Patients Enrolled

Taghrid Asfar, MDPrincipal Investigatortasfar@miami.edu

3 Previous Clinical Trials

233 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide a risk assessment of the Tobacco Quit-line (TQL) Group?

"Based on its Phase 4 status, the safety of Tobacco Quit-line (TQL) Group was rated a 3. This consideration is based off this pharmaceutical's approval from regulatory bodies."

Answered by AI

Are there any available openings in this research endeavor?

"It appears that clinicaltrials.gov does not indicate this study is actively enrolling patients, as the trial was initially posted on December 4th 2023 and last updated on October 18th 2023. Even though it has ended recruitment, there are still 187 other medical trials requiring participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Smoking Cessation Program in the Construction Sector

Taghrid Asfar 2024. "Smoking Cessation Program in the Construction Sector". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06098144.