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

• Sponsor: Centre for Addiction and Mental Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT04534231
• Collaborator: (none)
• Enrollment: 123
• Location: 1
• Actual Duration (Months): 10.3
• Patients Per Site Per Month: 11.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Tobacco Use Cessation	Drug: Nicotine patch

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?

Study Design

• Study Type: Observational
• Actual Enrollment: 123 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Oct 19, 2020
• Actual Primary Completion Date: Aug 30, 2021
• Actual Study Completion Date: Aug 30, 2021

Outcome Measures

Primary Outcome Measures

1. 30-day pint prevalence abstinence [6 months]

   No smoking of cigarettes in the past 30 days

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Addiction and Mental Health	Toronto	Ontario	Canada	M5S 2S1

Sponsors and Collaborators

• Centre for Addiction and Mental Health

Investigators

• Principal Investigator: John A Cunningham, PhD, Centre for Addiction and Mental Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: John Cunningham, Senior Scientist, Centre for Addiction and Mental Health
• ClinicalTrials.gov Identifier: NCT04534231
• Other Study ID Numbers: 122/2019
• First Posted: Sep 1, 2020
• Last Update Posted: Aug 31, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Nicotine

Study Results

No Results Posted as of Aug 31, 2021