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Completed

NCT Number: NCT01404546

Cost Free Pharmacotherapy for Smoking Cessation in Stroke Patients

This pilot study examined the effect of providing a 4 weeks of cost free quit smoking medications to smokers identified in a stroke prevention clinic who were interested in quitting smoking compared to providing a prescription for the medication only.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

About this study

DESIGN: Randomized controlled trial. METHODS: All patients seen at the Ottawa Hospital Stroke Prevention Clinic were screened for smoking status, advised to quit smoking and treated using a standardized protocol including counselling and pharmacotherapy. Eligible smokers were randomly assigned to either a prescription only usual care group, or, the experimental group who received a 4-week supply of cost-free quit smoking medications and prescription for medication renewal. All patients received follow-up counselling 7-days prior to and 5, 14, 30, 60, 90, 180 days following their quit attempt. Levels of eligibility, consent, adherence and retention were used as indicators of study feasibility. The primary outcome was bio-chemically validated quit rates at 26-weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients were eligible to participate in the study if they reported smoking an average of 5 or more cigarettes per day in past 3 months; were 18 years of age or older; were willing to set a quit date in the next 30 days; and were willing to use a quit smoking medication.

Exclusion criteria

  • Patients who were unable to read and understand English or French or who had contraindications to all approved smoking cessation medications (nicotine replacement therapy, bupropion, and varenicline) were excluded from the study.

Treatment and study plan

cost free pharmacotherapy

Other

Participants assigned to the CF group received a starter kit (4-week supply) of cost-free quit smoking medication (nicotine replacement therapy, bupropion, or varenicline) and a pre-printed prescription to be filled by the patient at the end of the 4-weeks.

Usual Care

Other

Participants assigned to the prescription only usual care group received a prescription for smoking cessation pharmacotherapy to be filled at their own cost at their local community pharmacy.

Primary outcomes

  1. smoking abstinence

    Time frame: 6-months

    The dependent variables of primary interest were measured at 26 weeks and included: (1) bio-chemically confirmed 7-day point prevalence abstinence; and (2) continuous abstinence since TQD. Participants who were not available for follow-up were considered smokers. At the 26 week follow-up, all patients who reported being abstinent from smoking had their smoking status confirmed by measurement of a CO sample. If any CO was >10 ppm, the subject was considered a smoker.

Secondary outcomes

  1. quit attempts

    Time frame: 6-months

    At the 26 week follow-up assessments patient quit attempts in the previous six months of 24 hours or longer were documented.

  2. adherence with intervention

    Time frame: 6-months

    During the 26-week telephone follow-up assessment patient adherence with pharmacotherapy was assessed by evaluating the number of doses of pharmacotherapy consumed within the prescribed study interval. The telephone counsellor recorded the completion of all seven counselling sessions in order to assess patient adherence.

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Official study title

A Randomized Controlled Pilot Study of Standardized Counselling and Cost-free Pharmacotherapy for Smoking Cessation Among Stroke and TIA Patients

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 28, 2011
Registry last updated
Mar 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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