Offering Nicotine Patches to All Households in a Municipa... | NCT04534231

Studies
Offering Nicotine Patches to All Households in a Municipality With High Smoking Rates

NCT04534231

Sponsor

Centre for Addiction and Mental Health

Status

Completed

Last Update Posted

Aug 31, 2021Actual

Enrollment

123Actual

Phase

Not provided

Conditions

Tobacco Use Cessation

Interventions

Nicotine patch

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 19, 2020Actual

Primary Completion Date

Aug 30, 2021Actual

Completion Date

Aug 30, 2021Actual

First Submitted Date

Aug 27, 2020

First Submission Date that Met QC Criteria

Aug 27, 2020

First Posted Date

Sep 1, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2021

Last Update Posted Date

Aug 31, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

John Cunningham, Senior Scientist, Centre for Addiction and Mental HealthPrincipal Investigator

Lead Sponsor

Centre for Addiction and Mental HealthOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

A coupon offering five weeks of free nicotine patches will be mailed to every household in a small municipality with elevated smoking rates. Up to 800 participants (one per household) will be able to redeem their coupon online or by phone, and receive nicotine patches via postal mail. Participants will be asked to complete a baseline survey containing items relevant to predicting smoking cessation. Participants will be asked to complete a six-month follow-up survey to assess changes in smoking status.

Research Question: Will the concentrated distribution of nicotine patches in a region of high smoking rates lead to large reductions in smoking rates?

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

123Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nicotine patch	Drug	Nicotine transdermal patches as per product monograph		Nicoderm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
30-day pint prevalence abstinence	No smoking of cigarettes in the past 30 days	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Primary residents of the target municipality

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John A Cunningham, PhD	Centre for Addiction and Mental Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre for Addiction and Mental Health		Toronto	Ontario	M5S 2S1	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41593728	Derived	Schell C, Godinho A, Cunningham JA. Investigating if changing the wording of a study invitation letter increased recruitment in a project promoting tobacco cessation in a town with high smoking rates. Subst Abuse Treat Prev Policy. 2026 Jan 27;21(1):15. doi: 10.1186/s13011-026-00704-x.
36264570	Derived	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.

ID	Term
D015438	Health Behavior
D001519	Behavior

ID	Term
D061485	Tobacco Use Cessation Devices
D009538	Nicotine

ID	Term
D013812	Therapeutics
D012991	Solanaceous Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds