Cost Free Pharmacotherapy for Smoking Cessation in Stroke Patients

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01404546
• Other study ID #: UOHI2010-1
• Status: Completed
• Phase: N/A
• First received: July 26, 2011
• Last updated: March 10, 2015
• Start date: August 2008
• Est. completion date: December 2010

Study information

• Verified date: July 2011
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	smoking abstinence	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.	6-months	No
Secondary	quit attempts	At the 26 week follow-up assessments patient quit attempts in the previous six months of 24 hours or longer were documented.	6-months	No
Secondary	adherence with intervention	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.	6-months	No