A Phase 4 interventional study of Nicorette Gum and Nicoderm CQ in Smoking Cessation, sponsored by University of Miami. Completed at 1 site in United States. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-07.
Sponsored by University of Miami · Phase 4, Interventional, and Treatment
Construction workers have the highest rate of smoking among all occupations, and are frequently exposed to a wide range of workplace hazards (e.g. toxins), which interact with smoking to increase their health risks. Minority construction workers, in particular, have higher smoking and lower cessation rates compared to other groups, and they generally show lower access and participation in cessation and health promotion services. The number of Hispanic workers employed in the construction industry in the US has tripled in the past decade to 2.6 million (23% of all construction workers). This study will develop, administer, and evaluate a novel smoking cessation program in a hard-to-reach and underserved population of Hispanic male construction workers using using pilot cluster randomized clinical trial (RCT) to test the developed intervention for feasibility and potential efficacy.
A two-arm, cluster-randomized controlled trial will be conducted with up to 15 construction sites, selected from one Construction Company in south Florida. Cluster randomization is used with construction site chosen as the unit of allocation because it is most practical in this setting and minimizes the risk of spillover effects from the intervention to the control group. In conjunction with the site's safety manager, the investigators will recruit 9 adult Hispanic construction workers per site (126 total) who smoke ≥5 cigarettes/day in the last year. Participants in the enhanced care will receive one culturally adapted brief face-to-face behavioral counseling session developed in phase 1 and delivered at a lunch truck, two brief follow-up phone counseling calls, fax referral to the Florida quitline (QL), and provision of up to 6 weeks of free NRT. Participants in the standard care will receive fax referral to the Florida QL, and provision of up to 8 weeks of free NRT.
350 studies on the registry are indexed under Smoking Cessation; 145 are open to participants now.
This study's enrollment of 134 is below the median of 150 across 326 interventional studies indexed under Smoking Cessation.
Browse Smoking Cessation studies →University of Miami is the lead sponsor of 838 studies on the registry; 164 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 96 (84%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Interventions: Nicorette Gum/Nicoderm CQ, Behavioral Smoking Cessation Counseling \& Smoking Quitline Referral. Participants in the "Enhanced Care" intervention arm will receive a single face-to-face behavioral counseling session delivered at the construction site lunch truck, two brief follow-up phone counseling calls, fax referral to the Florida tobacco quitline (QL), and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants in will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
Drug: Nicorette Gum · Drug: Nicoderm CQ · Other: Smoking Quitline Referral · Behavioral: Behavioral Smoking Cessation Counseling
Interventions: Nicorette Gum/Nicoderm CQ, Smoking Quitline Referral. The "Standard Care" group (NRT) will receive fax referral to the Florida QL and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
Drug: Nicorette Gum · Drug: Nicoderm CQ · Other: Smoking Quitline Referral
GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
Also known as: NRT
Drug pages: Nicotine · Nicotine Patch
GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
Also known as: NRT
Fax referral to the State smoking Quitline
Also known as: Quitline
One time face-to-face smoking cessation counseling and follow-up phone call
Also known as: Counseling
Prolonged Abstinence Rates
Prolonged abstinence is defined as no smoking, not even a puff, after a grace period of two weeks after quit date. This will be assessed in follow up questionnaire and confirmed with saliva cotinine level of \<15 ng/ml.
Time frame: 6-month
7-day Point- Prevalence Prolonged Abstinence Rate
Point prevalence abstinence rates is defined as self report of not smoking; in the past 7 days not even a puff) confirmed by saliva cotinine level of \<15ng/ml.
Time frame: 6-month
Enrollment Rate
Enrollment rate will be reported as the percentage of participants that were eligible and randomized against the participants screened.
Time frame: Baseline
Quitline Response Rate
Quitline Response will be reported by the percentage of participants that contacted the Quitline, enrolled in the tobacco Quitline and the participants that completed at least 1 phone call from Tobacco Quitline.
Time frame: 6-month
Follow-Up Rate
Follow up rate will be reported as the percentage of participants that completed their follow up visit.
Time frame: 3-month, 6-month
Questionnaire Response Rate
Questionnaire response rate will be reported by the percentage of participants that completed the initial and follow up questionnaire.
Time frame: 6-month
Rate of Compliance to Intervention
Rate of compliance to intervention is reported as the percentage of participants who self-reported following intervention components at follow-up.
Time frame: 6-month
Change in Number of Cigarettes Smoked
For the participants that did not quit, the change in number of cigarettes smoked will be reported as the number of cigarettes smoked per day at the 6 months follow up visit minus the number of cigarettes smoked per day at baseline
Time frame: Baseline, 6-month
| Milestone | Enhanced Care | Standard Care |
|---|---|---|
| Started | 65 | 69 |
| Completed | 65 | 69 |
| Not completed | 0 | 0 |
| Milestone | Enhanced Care | Standard Care |
|---|---|---|
| Started | 65 | 69 |
| Completed | 43 | 47 |
| Not completed | 22 | 22 |
| Withdrew: Lost to follow-up | 22 | 22 |
| Milestone | Enhanced Care | Standard Care |
|---|---|---|
| Started | 65 | 69 |
| Completed | 50 | 46 |
| Not completed | 15 | 23 |
| Withdrew: Lost to follow-up | 15 | 23 |
Prolonged abstinence is defined as no smoking, not even a puff, after a grace period of two weeks after quit date. This will be assessed in follow up questionnaire and confirmed with saliva cotinine level of \<15 ng/ml.
| Percentage of participants | Enhanced Care | Standard Care |
|---|---|---|
| Prolonged Abstinence Rates | 36.00 | 30.43 |
Point prevalence abstinence rates is defined as self report of not smoking; in the past 7 days not even a puff) confirmed by saliva cotinine level of \<15ng/ml.
| Percentage of participants | Enhanced Care | Standard Care |
|---|---|---|
| 7-day Point- Prevalence Prolonged Abstinence Rate | 36.00 | 30.43 |
Enrollment rate will be reported as the percentage of participants that were eligible and randomized against the participants screened.
| Percentage of participants | All Workers Available - Before Randomization |
|---|---|
| Eligible Participants | 85.9 |
| Randomized participants | 85.9 |
Quitline Response will be reported by the percentage of participants that contacted the Quitline, enrolled in the tobacco Quitline and the participants that completed at least 1 phone call from Tobacco Quitline.
| Percentage of participants | Enhanced Care | Standard Care |
|---|---|---|
| Contacted by tobacco Quitline | 49.2 | 40.6 |
| Enrolled in tobacco Quitline | 29.23 | 23.19 |
| Completed at least 1 phone calls from tobacco QL | 23.08 | 11.59 |
Follow up rate will be reported as the percentage of participants that completed their follow up visit.
| Percentage of participants | Enhanced Care | Standard Care |
|---|---|---|
| 3-month follow-up | 66.15 | 68.12 |
| 6-month follow-up | 76.92 | 66.67 |
Questionnaire response rate will be reported by the percentage of participants that completed the initial and follow up questionnaire.
| Percentage of participants | Enhanced Care | Standard Care |
|---|---|---|
| completed initial questionnaire | 93.85 | 88.41 |
| Completed follow-up questionnaire | 76.92 | 66.67 |
Rate of compliance to intervention is reported as the percentage of participants who self-reported following intervention components at follow-up.
| Percentage of participants | Enhanced Care | Standard Care |
|---|---|---|
| Counseling session + 2 phone calls | 43.08 | 88.40 |
| 6 weeks NRT | 93.85 | 88.41 |
| 4 Quitline counseling sessions | 6.15 | 2.9 |
| 2 weeks NRT from Quitline | 15.38 | 13.04 |
For the participants that did not quit, the change in number of cigarettes smoked will be reported as the number of cigarettes smoked per day at the 6 months follow up visit minus the number of cigarettes smoked per day at baseline
| Cigarettes smoked per day | Enhanced Care | Standard Care |
|---|---|---|
| Change in Number of Cigarettes Smoked | -13.5 ± 1.5 | -11.5 ± 1.3 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Enhanced Care | 0/65 (0%) | 0/65 (0%) | 0/65 (0%) |
| Standard Care | 0/69 (0%) | 0/69 (0%) | 0/69 (0%) |
| Age, Continuous(years) | Enhanced Care | Standard Care | Total |
|---|---|---|---|
| Mean | 40.9 ± 1.5 | 38.2 ± 1.4 | 39.5 ± 1.8 |
| Sex: Female, Male(Participants) | Enhanced Care | Standard Care | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 65 | 69 | 134 |
| Ethnicity (NIH/OMB)(Participants) | Enhanced Care | Standard Care | Total |
|---|---|---|---|
| Hispanic or Latino | 65 | 69 | 134 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Enhanced Care | Standard Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 2 | 2 |
| White | 6 | 10 | 16 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 58 | 57 | 115 |
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