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Smoking CessationPhase 4NCT02873377

Smoking Cessation in Hispanic Construction Workers

A Phase 4 study testing Nicorette Gum, Nicoderm CQ and Smoking Quitline Referral in people with Smoking Cessation, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Smoking Cessation
What is being tested?
Nicorette Gum, Nicoderm CQ and Smoking Quitline Referral
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
1 siteUnited States
Study dates
13 Apr 2017to 11 Oct 2018
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Hispanic
  • Construction worker
  • Have smoked ≥ 5 cigarettes/day in the past year.
  • Have access to telephone
  • Have no plans to move in the next six months
  • Are interested in making a serious quit attempt in the next 30 days
  • Have no contraindication to NRT (e.g., history of hypersensitivity to nicotine, recent (past month) myocardial infarction, any history of serious arrhythmias or unstable angina pectoris, chronic dermatological disorder (e.g., psoriasis)).

Who cannot join

  • Inability to understand consent procedures
  • Not Hispanic
  • Not a construction worker
  • Haven't smoked ≥ 5 cigarettes/day in the past year.
  • No access to telephone
  • Has plans to move in the next six months
Show all 9Show fewer
  • Not interested in making a serious quit attempt in the next 30 days
  • Has a contraindication to NRT
  • Has a generalized chronic dermatological disorder (e.g., psoriasis)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Clinical Research Building University of Miami

    Miami, Florida, 33136

Other trials in United States

About this study

Official title: A Novel Worksite Smoking Cessation Intervention for Hispanic Construction Workers

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.

Read the detailed description

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.

Being tested
Nicorette Gum, Nicoderm CQ, Smoking Quitline Referral, Behavioral Smoking Cessation Counseling
Keywords
Hispanics, Construction workers, Tobacco Quitline, Nicotine replacement therapy
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nicorette GumDrug

    Also called NRT

    GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)

  • Nicoderm CQDrug

    Also called NRT

    GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)

  • Smoking Quitline ReferralOther

    Also called Quitline

    Fax referral to the State smoking Quitline

  • Behavioral Smoking Cessation CounselingBehavioural

    Also called Counseling

    One time face-to-face smoking cessation counseling and follow-up phone call

Study groups in NCT02873377
Study groupRoleWhat they receive
Enhanced CareExperimentalInterventions: 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.
Receives: Drug: Nicorette Gum; Drug: Nicoderm CQ; Other: Smoking Quitline Referral; Behavioral: Behavioral Smoking Cessation Counseling
Standard CareActive comparatorInterventions: 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.
Receives: Drug: Nicorette Gum; Drug: Nicoderm CQ; Other: Smoking Quitline Referral

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6-month

Secondary outcomes (7)

  1. 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.

    Measured: 6-month

  2. Enrollment Rate

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

    Measured: Baseline

  3. 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.

    Measured: 6-month

  4. Follow-Up Rate

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

    Measured: 3-month, 6-month

  5. Questionnaire Response Rate

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

    Measured: 6-month

  6. 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.

    Measured: 6-month

  7. 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

    Measured: Baseline, 6-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2016 (estimated)
  2. Study start13 Apr 2017
  3. Primary completion11 Oct 2018
  4. Study completion11 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Study arms will be conducted simultaneously.
Masking
None (open label)
Enrolment
134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02873377
Sponsor's protocol ID
20140019
Other IDs
1R21CA202993-01A1
Status last verified
Oct 2019
First submitted
28 Jul 2016
Last updated
7 Nov 2019
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Asfar T, Arheart KL, McClure LA, Ruano-Herreria EC, Dietz NA, Ward KD, Caban-Martinez AJ, Samano Martin Del Campo D, Lee DJ. Implementing a Novel Workplace Smoking Cessation Intervention Targeting Hispanic/Latino Construction Workers: A Pilot Cluster Randomized Trial. Health Educ Behav. 2021 Dec;48(6):795-804. doi: 10.1177/1090198120960395. Epub 2020 Oct 16.

    PubMed 33063570

  • Asfar T, McClure LA, Arheart KL, Ruano-Herreria EC, Gilford CG Jr, Moore K, Dietz NA, Ward KD, Lee DJ, Caban-Martinez AJ. Integrating Worksite Smoking Cessation Services Into the Construction Sector: Opportunities and Challenges. Health Educ Behav. 2019 Dec;46(6):1024-1034. doi: 10.1177/1090198119866900. Epub 2019 Aug 19.

    PubMed 31426671

  • Asfar T, Caban-Martinez AJ, McClure LA, Ruano-Herreria EC, Sierra D, Gilford Clark G Jr, Samano D, Dietz NA, Ward KD, Arheart KL, Lee DJ. A cluster randomized pilot trial of a tailored worksite smoking cessation intervention targeting Hispanic/Latino construction workers: Intervention development and research design. Contemp Clin Trials. 2018 Apr;67:47-55. doi: 10.1016/j.cct.2018.02.007. Epub 2018 Feb 14.

    PubMed 29454141

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nicorette Gum, Nicoderm CQ and Smoking Quitline Referral in people with Smoking Cessation, run by University of Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prolonged Abstinence Rates (time frame: 6-month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02873377, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2019.

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Smoking Cessation in Hispanic Construction Workers | AzTrials