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NCT04534231 Clinical Trial

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

Tobacco Use Cessation Clinical Trial

Official title:
Offering Nicotine Patches to All Households in a Municipality With High Smoking Rates: Test of an Idea to Promote Large Increases in Tobacco Cessation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04534231
Other study ID # 122/2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 19, 2020
Est. completion date August 30, 2021

Study information
Verified date August 2021
Source Centre for Addiction and Mental Health
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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?

Recruitment information / eligibility
Status Completed
Enrollment 123
Est. completion date August 30, 2021
Est. primary completion date August 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Nicotine patch
Nicotine transdermal patches as per product monograph

Locations
Country Name City State
Canada Centre for Addiction and Mental Health Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 30-day pint prevalence abstinence No smoking of cigarettes in the past 30 days 6 months
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