Clinical trial NCT03097445: Long-term Effectiveness of Mailed Nicotine Replacement Therapy: A 5-year Follow-up
Official title: Long-term Effectiveness of Mailed Nicotine Replacement Therapy: A 5-year Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Smoking
Nicotine
Nicotine Replacement Therapy
Nicotine Patch
Mass Distribution
Tobacco Control
Cancer Prevention
Randomized Controlled Trial
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
First posted: 2017-03-31
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Smoking Cessation
timeFrame: 5-years post intervention
Secondary outcomes:
measure: Prolonged Abstinence
timeFrame: 5 years post intervention
measure: Continuous Abstinence
timeFrame: 5 years post intervention
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: John Cunningham, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.