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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
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
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.
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.
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 belowSelect...
I am 18 years old or older.
Select...
I am a company leader and I am 18 years old or older.
Select...
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
Program's Implementation- Acceptability Measured by Likert Scale
Program's Implementation- Feasibility Measured by Likert Scale
Program's Implementation- Sustainability Measured by Likert Scale
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
955 Previous Clinical Trials
428,245 Total Patients Enrolled
Florida Department of HealthOTHER_GOV
29 Previous Clinical Trials
12,421 Total Patients Enrolled
Taghrid Asfar, MDPrincipal Investigatortasfar@miami.edu
3 Previous Clinical Trials
191 Total Patients Enrolled