NCT04534231

Brief Summary

One municipality with high smoking rates will be selected. A coupon for free-of-charge nicotine patches will be sent to each household. Reductions in the number of people smoking in the chosen municipality from before to after the NRT distribution will be estimated

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

October 19, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

11 months

First QC Date

August 27, 2020

Last Update Submit

August 30, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 30-day pint prevalence abstinence

    No smoking of cigarettes in the past 30 days

    6 months

Interventions

Nicotine transdermal patches as per product monograph

Also known as: Nicoderm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary residents of the target municipality

You may qualify if:

  • speak and understand English
  • years or older
  • smoke 10 or more cigarettes per day for at least 3 months

You may not qualify if:

  • health contraindications for using nicotine patches without supervision of a doctor (e.g. allergy to tape, pregnant or intending to become pregnant, currently breastfeeding, serious heart or circulation problems not including high blood pressure)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

Related Publications (2)

  • Cunningham JA, Leatherdale ST, Chaiton M, Tyndale RF, Schell C, Godinho A. Concentrated Distribution of Nicotine Patches to a Town With High Smoking Rates-Any Evidence of Large Impacts on Tobacco Cessation? Nicotine Tob Res. 2023 Apr 6;25(5):1060-1061. doi: 10.1093/ntr/ntac244. No abstract available.

  • Cunningham JA, Leatherdale ST, Chaiton M, Tyndale RF, Schell C, Godinho A. Offering nicotine patches to all households in a community with high smoking rates: Pilot test of a population-based approach to promote tobacco cessation. Int J Popul Data Sci. 2021 Feb 11;6(1):1400. doi: 10.23889/ijpds.v6i1.1400.

Biospecimen

Retention: NONE RETAINED

Saliva samples

MeSH Terms

Conditions

Tobacco Use Cessation

Interventions

Tobacco Use Cessation DevicesNicotine

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

TherapeuticsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • John A Cunningham, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

August 27, 2020

First Posted

September 1, 2020

Study Start

October 19, 2020

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

August 31, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations