Cost Free Pharmacotherapy for Smoking Cessation in Stroke Patients

This study has been completed.
Sponsor:
Information provided by:
University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT01404546
First received: July 26, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted

July 26, 2011
July 26, 2011
August 2008
December 2010   (final data collection date for primary outcome measure)
smoking abstinence [ Time Frame: 6-months ] [ Designated as safety issue: No ]
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.
Same as current
No Changes Posted
  • quit attempts [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    At the 26 week follow-up assessments patient quit attempts in the previous six months of 24 hours or longer were documented.
  • adherence with intervention [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Cost Free Pharmacotherapy for Smoking Cessation in Stroke Patients
A Randomized Controlled Pilot Study of Standardized Counselling and Cost-free Pharmacotherapy for Smoking Cessation Among Stroke and TIA 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Stroke
  • 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.
  • 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.
  • Experimental: 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: Other: cost free pharmacotherapy
  • Active Comparator: 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.
    Intervention: Other: usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01404546
UOHI2010-1
No
Robert Reid, University of Ottawa Heart Institute
University of Ottawa Heart Institute
Not Provided
Principal Investigator: Robert Reid, Ph.D. Associate Director and Professor
University of Ottawa Heart Institute
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP