Randomized Trial Assessing the Effectiveness of a Pharmacist-Delivered Program for Smoking Cessation

Study Overview
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Brief Summary
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This randomized trial compared the effectiveness of a three session pharmacist-delivered group program for smoking versus one 5 to 10 minute standard care session delivered over the telephone on 7-day point prevalence quit rates. Participants in both groups were offered their choice of bupropion IR or nicotine patch at no cost. At 6 months after the established quit date, self-reported cessation was biochemically verified using tests for urinary cotinine.

Official Title
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Randomized Trial Assessing the Effectiveness of a Pharmacist-Delivered Program for Smoking Cessation

Conditions
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Tobacco Use Disorder, Smoking

Intervention / Treatment
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* Other: Pharmacist-delivered group program for smoking cessation
* Other: Brief standard care session for smoking cessation delivered over the telephone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Smoked one or more cigarettes daily for 7 days Somewhat ready to quit in the next 2 weeks (4 or more on a 10- point scale) Willing and capable of attending three scheduled sessions at the clinic Interested in participating in the study Exclusion Criteria: Planned to leave the area in the next 6 months Used pharmacotherapy for smoking cessation in the last 30 days Used other forms of tobacco in the last 30 days Schizophrenia Prior participation

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Pharmacist-delivered group program for smoking cession. | Other: Pharmacist-delivered group program for smoking cessation<br>* Participants assigned to the treatment group participated in a pharmacist-delivered program at the clinic. The six-hour program consisted of three in-person sessions delivered at 2-week intervals over 5 weeks to a small group of smokers. Participants were offered their choice of one medication either bupropion IR or nicotine patch using doses and durations based on current medical practices. Participants receiving bupropion received a quantity sufficient to complete 12 weeks of therapy. Participants receiving nicotine patches received a quantity sufficient to complete 8 weeks of step-down therapy.<br>|
| Placebo Comparator: 2<br>Brief standard care session for tobacco smoking cessation delivered over the telephone. | Other: Brief standard care session for smoking cessation delivered over the telephone<br>* Those assigned to the control group received one 5 to 10 minute session delivered by the clinical pharmacist over the telephone that included all the components of standard care recommended by the Clinical Practice Guidelines for brief interventions delivered by health care providers. Participants were offered their choice of one medication either bupropion IR or nicotine patch using doses and durations based on current medical practices. Participants receiving bupropion received a quantity sufficient to complete 12 weeks of therapy. Participants receiving nicotine patches received a quantity sufficient to complete 8 weeks of step-down therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome variable for the study was biochemically verified 7-day point prevalence smoking cessation at 6 months, defined as having smoked no cigarettes - not even a puff - for the previous 7 days. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcomes included 30-day point prevalence abstinence and prolonged abstinence (>6 months). |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking cessation, Pharmacist-delivered