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

Sponsor

Centre for Addiction and Mental Health (Other)

Overall Status

Completed

CT.gov ID

NCT03097445

Collaborator

Canadian Cancer Society (CCS) (Other)

1,000

Enrollment

Location

Arms

26.6

Actual Duration (Months)

37.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation	Drug: Nicotine patch	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 4, 2017

Actual Primary Completion Date :

Aug 22, 2019

Actual Study Completion Date :

Aug 22, 2019

Arms and Interventions

Arm	Intervention/Treatment
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
No Intervention: Control No intervention control group

Arm

Intervention/Treatment

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

No Intervention: Control

No intervention control group

Outcome Measures

Primary Outcome Measures

Smoking Cessation [5-years post intervention]
self-reported 30-day point prevalence abstinence

Secondary Outcome Measures

Prolonged Abstinence [5 years post intervention]
self-reported prolonged 6-month abstinence
Continuous Abstinence [5 years post intervention]
self-reported continuous > 4 years abstinence

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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