NCT03097445

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 4, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2019

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

2.2 years

First QC Date

March 25, 2017

Last Update Submit

January 22, 2020

Conditions

Smoking Cessation

Keywords

SmokingNicotineNicotine Replacement TherapyNicotine PatchMass DistributionTobacco ControlCancer PreventionRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Smoking Cessation

    self-reported 30-day point prevalence abstinence

    5-years post intervention

Secondary Outcomes (2)

  • Prolonged Abstinence

    5 years post intervention

  • Continuous Abstinence

    5 years post intervention

Study Arms (2)

Nicotine Replacement Therapy

EXPERIMENTAL

mailed 5 week course of transdermal nicotine patches

Drug: Nicotine patch

Control

NO INTERVENTION

No intervention control group

Interventions

Nicotine patchDRUG

mailed 5-week course of Habitrol® transdermal nicotine patches

Also known as: Habitrol® transdermal nicotine patches
Nicotine Replacement Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

Related Publications (2)

  • 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.

    PMID: 30442187DERIVED

  • 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: 28720080DERIVED

Related Links

MeSH Terms

Conditions

Smoking CessationSmoking

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • John Cunningham, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

March 25, 2017

First Posted

March 31, 2017

Study Start

June 4, 2017

Primary Completion

August 22, 2019

Study Completion

August 22, 2019

Last Updated

January 23, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)