Cost Free Pharmacotherapy for Smoking Cessation in Stroke Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cost Free Pharmacotherapy

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.

Group Type EXPERIMENTAL

cost free pharmacotherapy

Intervention Type 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 Group

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.

Group Type ACTIVE_COMPARATOR

usual care

Intervention Type 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.

Interventions

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cost free pharmacotherapy

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.

Intervention Type OTHER

usual care

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No