Randomized Controlled Trial of Mailed Nicotine Replacement Therapy to Canadian Smokers

NCT01429129 | Completed Phase 4

• 1 other identifier: 029/2011
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the efficacy of mailed distribution of free Nicotine Replacement Therapy to smokers. Telephone numbers will be randomly selected from across Canada in order to recruit adult smokers interested in completing a smoking survey and willing to be interviewed again in 8 weeks and 6 months time. Study participants will be asked about their smoking history and a hypothetical question: would they be interested in receiving the nicotine patch if this were to be provided to them free of charge? Participants expressing interest will be randomly assigned to one of two groups. One group will be offered the opportunity to actually receive a program of 5 weeks of the nicotine patch for free right away and the other group will not be offered the free nicotine patches. The proportions of smokers in the two groups who quit smoking by the 6-month interview will be compared.

Conditions

Smoking

Keywords

Smoking; Nicotine; Nicotine Replacement Therapy; Nicotine Patch; Nicoderm; Mass Distribution; Tobacco Control; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Smoking cessation

  6 month follow-up

Secondary Outcomes (4)

• Smoking cessation

  8 week follow-up

• Reduction in smoking since baseline

  past 6 months

• Compliance with course of nicotine patches provided

  past 6 months

• Purchase and use of NRT and smoking cessation aids

  past 6 months

Study Arms (2)

Nicotine Replacement Therapy

EXPERIMENTAL

Drug: Nicotine replacement therapy

Control

NO INTERVENTION

Interventions

Nicotine replacement therapy DRUG

Nicotine transdermal patches as per product monograph

Also known as: Nicoderm

Nicotine Replacement Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and older
• Current daily smokers who smoke 10 or more cigarettes per day
• Interested in being involved in a smoking study
• Willing to be interviewed at baseline, 8 weeks and 6 months after
• Willing to provide a saliva sample for cotinine analysis at each time point
• Interest in using nicotine patch to quit smoking
• Intent to use nicotine patch within one week of receiving it
• Willing to have nicotine patch sent to their home

You may not qualify if:

• Have a medical condition that would would make participation medically hazardous as determined by the list of contraindications for NRT outlined in the CPS and the NRT package insert
• Pregnant, intending on becoming pregnant, or nursing

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

Related Publications (5)

• Kushnir V, Selby P, Zawertailo L, Tyndale RF, Leatherdale ST, Cunningham JA. Long-term effectiveness of mailed nicotine replacement therapy: study protocol of a randomized controlled trial 5-year follow-up. BMC Public Health. 2017 Jul 18;18(1):28. doi: 10.1186/s12889-017-4586-z.

  PMID: 28720080 DERIVED

• Kushnir V, Sproule BA, Cunningham JA. Impact of large-scale distribution and subsequent use of free nicotine patches on primary care physician interaction. BMC Public Health. 2017 Jul 11;18(1):4. doi: 10.1186/s12889-017-4548-5.

  PMID: 28693456 DERIVED

• Kushnir V, Sproule BA, Zawertailo L, Selby P, Tyndale RF, Leatherdale ST, Cunningham JA. Impact of self-reported lifetime depression or anxiety on effectiveness of mass distribution of nicotine patches. Tob Control. 2016 Sep;26(5):526-533. doi: 10.1136/tobaccocontrol-2016-052994. Epub 2016 Aug 19.

  PMID: 27543563 DERIVED

• Cunningham JA, Kushnir V, Selby P, Tyndale RF, Zawertailo L, Leatherdale ST. Effect of Mailing Nicotine Patches on Tobacco Cessation Among Adult Smokers: A Randomized Clinical Trial. JAMA Intern Med. 2016 Feb;176(2):184-90. doi: 10.1001/jamainternmed.2015.7792.

  PMID: 26809849 DERIVED

• Cunningham JA, Leatherdale ST, Selby PL, Tyndale RF, Zawertailo L, Kushnir V. Randomized controlled trial of mailed Nicotine Replacement Therapy to Canadian smokers: study protocol. BMC Public Health. 2011 Sep 28;11:741. doi: 10.1186/1471-2458-11-741.

  PMID: 21955930 DERIVED

MeSH Terms

Conditions

Smoking

Interventions

Nicotine Replacement Therapy; Nicotine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• John Cunningham, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: September 2, 2011
• First Posted: September 5, 2011
• Study Start: May 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: May 1, 2015
• Last Updated: October 16, 2015

Record last verified: 2015-10

Locations

CA (1)