Cost Free Pharmacotherapy for Smoking Cessation in Stroke Patients

NCT01404546 | Completed

• 1 other identifier: UOHI2010-1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

stroke smoking cessation cost-free pharmacotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• quit attempts

  6-months

• adherence with intervention

  6-months

Study Arms (2)

Cost Free Pharmacotherapy

EXPERIMENTAL

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.

Other: cost free pharmacotherapy

Usual Care Group

ACTIVE COMPARATOR

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.

Other: usual care

Interventions

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.

Cost Free Pharmacotherapy

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.

Usual Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Robert Reid, Ph.D.

  Associate Director and Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: July 28, 2011
• Study Start: August 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 11, 2015

Record last verified: 2011-07

Locations

CA (1)