NCT02873377

Smoking Cessation in Hispanic Construction Workers

Completed Phase 4 Results posted Last updated 7 November 2019

What this trial tests

Phase 4 trial testing Nicorette Gum in Smoking Cessation in 134 participants. Completed in 11 October 2018.

Timeline

13 April 2017

Primary endpoint
11 October 2018

11 October 2018

Quick facts

Lead sponsor	University of Miami
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	134
Start date	13 April 2017
Primary completion	11 October 2018
Estimated completion	11 October 2018
Sites	1 location across United States

Drugs / interventions tested

• Nicorette Gum — full drug profile →
• Nicoderm CQ
• Smoking Quitline Referral
• Behavioral Smoking Cessation Counseling

Conditions studied

• Smoking Cessation — all drugs for Smoking Cessation →

Sponsor

University of Miami

Who can join

18 and older, male only, with Smoking Cessation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Prolonged Abstinence Rates Primary · 6-month

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.

Group	Value	95% CI
Enhanced Care	36.00
Standard Care	30.43

7-day Point- Prevalence Prolonged Abstinence Rate Secondary · 6-month

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.

Group	Value	95% CI
Enhanced Care	36.00
Standard Care	30.43

Enrollment Rate Secondary · Baseline

Enrollment rate will be reported as the percentage of participants that were eligible and randomized against the participants screened.

Eligible Participants

Group	Value	95% CI
All Workers Available - Before Randomization	85.9

Randomized participants

Group	Value	95% CI
All Workers Available - Before Randomization	85.9

Quitline Response Rate Secondary · 6-month

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.

Contacted by tobacco Quitline

Group	Value	95% CI
Enhanced Care	49.2
Standard Care	40.6

Enrolled in tobacco Quitline

Group	Value	95% CI
Enhanced Care	29.23
Standard Care	23.19

Completed at least 1 phone calls from tobacco QL

Group	Value	95% CI
Enhanced Care	23.08
Standard Care	11.59

Follow-Up Rate Secondary · 3-month, 6-month

Follow up rate will be reported as the percentage of participants that completed their follow up visit.

3-month follow-up

Group	Value	95% CI
Enhanced Care	66.15
Standard Care	68.12

6-month follow-up

Group	Value	95% CI
Enhanced Care	76.92
Standard Care	66.67

Questionnaire Response Rate Secondary · 6-month

Questionnaire response rate will be reported by the percentage of participants that completed the initial and follow up questionnaire.

completed initial questionnaire

Group	Value	95% CI
Enhanced Care	93.85
Standard Care	88.41

Completed follow-up questionnaire

Group	Value	95% CI
Enhanced Care	76.92
Standard Care	66.67

Rate of Compliance to Intervention Secondary · 6-month

Rate of compliance to intervention is reported as the percentage of participants who self-reported following intervention components at follow-up.

Counseling session + 2 phone calls

Group	Value	95% CI
Enhanced Care	43.08
Standard Care	88.40

6 weeks NRT

Group	Value	95% CI
Enhanced Care	93.85
Standard Care	88.41

4 Quitline counseling sessions

Group	Value	95% CI
Enhanced Care	6.15
Standard Care	2.9

2 weeks NRT from Quitline

Group	Value	95% CI
Enhanced Care	15.38
Standard Care	13.04

Change in Number of Cigarettes Smoked Secondary · Baseline, 6-month

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

Group	Value	95% CI
Enhanced Care	-13.5	± 1.5
Standard Care	-11.5	± 1.3

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A cluster randomized pilot trial of a tailored worksite smoking cessation intervention targeting Hispanic/Latino construction workers: Intervention development and research design.
   Asfar T, Caban-Martinez AJ, McClure LA, Ruano-Herreria EC, et al · · 2018 · cited 12× · PMID 29454141 · DOI 10.1016/j.cct.2018.02.007