Long-term Effectiveness of Mailed Nicotine Replacement Therapy: A 5-year Follow-up

This study will perform a 5-year follow-up survey of participants in a randomized controlled trial that evaluated the effectiveness of providing 5 weeks of free NRT (in the form of the nicotine patch) by expedited postal mail without behavioural assistance to regular adult smokers recruited across Canada interested in receiving it (clinicaltrials.gov Identifier: NCT01429129).

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: Nicotine patch

Detailed Description

Our group recently completed a randomized controlled trial evaluating the efficacy of providing 5 weeks of free NRT (in the form of the nicotine patch) by expedited postal mail without behavioural assistance to regular adult smokers recruited across Canada interested in receiving it (clinicaltrials.gov Identifier: NCT01429129). The findings revealed that the provision of free nicotine patches via mail resulted in more than a doubling of 30-day abstinence quit rates at a six-month follow-up compared to the no intervention control group (7.6% versus 3.0%; odds ratio of 2.65). While this trial provided evidence for the effectiveness of nicotine patches as a tobacco cessation aid in real world settings, the findings speak only to the short-term effectiveness of NRT. As evidence for NRT effectiveness has been largely restricted to a final follow-up of 6-12 months after the start of treatment, and relapse to smoking is known to occur beyond this period, it is important to evaluate whether the net benefit of NRT in naturalistic settings can be maintained long-term.

Employing a survey research call centre, trained interviewers will contact participants in the original randomized controlled trial, 5 years post-enrollment. A total of 924 subjects will be eligible to be contacted, however intent-to-treat analyses will evaluate outcomes based on all 1000 participants randomized to condition in the original trial. In this 5-year follow-up survey, interviewers will first assess participants' smoking status, the number of cigarettes smoked per day and their level of nicotine dependence. Participants reporting not currently smoking will be asked whether they have smoked tobacco, even a puff, in the last 30 days (primary outcome measure: abstinence using 30 day point prevalence), past 6 months (secondary outcome measure: prolonged 6-month abstinence), and since the last follow-up survey (secondary outcome measure: > 4 year continuous abstinence). Interviewers will be blind to experimental condition at the time the primary outcome measure will be assessed. The survey component of the proposed study will be conducted over a 2 year period to coincide with the duration of subject recruitment in the original trial. The primary hypothesis is that subjects who received nicotine patches at baseline will display significantly higher quit rates at the 5-year follow-up as compared to subjects who did not receive nicotine patches at baseline.

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 2S1
      • Centre for Addiction and Mental Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No intervention control group
Experimental: Nicotine Replacement Therapy; mailed 5 week course of transdermal nicotine patches	Drug: Nicotine patch; mailed 5-week course of Habitrol® transdermal nicotine patches; Other Names: Habitrol® transdermal nicotine patches

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking Cessation	self-reported 30-day point prevalence abstinence	5-years post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prolonged Abstinence	self-reported prolonged 6-month abstinence	5 years post intervention
Continuous Abstinence	self-reported continuous > 4 years abstinence	5 years post intervention

Collaborators and Investigators

• Sponsor: Centre for Addiction and Mental Health
• Collaborators: Canadian Cancer Society (CCS)
• Investigators: Principal Investigator: John Cunningham, PhD, Centre for Addiction and Mental Health

Publications and helpful links

General Publications

• 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. Erratum In: BMC Public Health. 2017 Sep 22;17 (1):736.
• Schell C, Godinho A, Kushnir V, Cunningham JA. To send or not to send: weighing the costs and benefits of mailing an advance letter to participants before a telephone survey. BMC Res Notes. 2018 Nov 15;11(1):813. doi: 10.1186/s13104-018-3920-6.

Helpful Links

• Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating Centre

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2017
• Primary Completion (Actual): August 22, 2019
• Study Completion (Actual): August 22, 2019

Study Registration Dates

• First Submitted: March 25, 2017
• First Submitted That Met QC Criteria: March 25, 2017
• First Posted (Actual): March 31, 2017

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Smoking; Randomized Controlled Trial; Nicotine; Cancer Prevention; Nicotine Patch; Nicotine Replacement Therapy; Tobacco Control; Mass Distribution
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 216-2005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No