Randomized Trial Assessing the Effectiveness of a Pharmacist-Delivered Program for Smoking Cessation
Primary Purpose
Tobacco Use Disorder, Smoking
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pharmacist-delivered group program for smoking cessation
Brief standard care session for smoking cessation delivered over the telephone
Sponsored by
About this trial
This is an interventional treatment trial for Tobacco Use Disorder focused on measuring Smoking cessation, Pharmacist-delivered
Eligibility Criteria
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
Sites / Locations
- Missoula VA Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Pharmacist-delivered group program for smoking cession.
Brief standard care session for tobacco smoking cessation delivered over the telephone.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Secondary outcomes included 30-day point prevalence abstinence and prolonged abstinence (>6 months).
Full Information
NCT ID
NCT00670904
First Posted
April 30, 2008
Last Updated
January 11, 2010
Sponsor
University of Montana
Collaborators
Prevent Cancer Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00670904
Brief Title
Randomized Trial Assessing the Effectiveness of a Pharmacist-Delivered Program for Smoking Cessation
Official Title
Randomized Trial Assessing the Effectiveness of a Pharmacist-Delivered Program for Smoking Cessation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Montana
Collaborators
Prevent Cancer Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder, Smoking
Keywords
Smoking cessation, Pharmacist-delivered
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Pharmacist-delivered group program for smoking cession.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Brief standard care session for tobacco smoking cessation delivered over the telephone.
Intervention Type
Other
Intervention Name(s)
Pharmacist-delivered group program for smoking cessation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Brief standard care session for smoking cessation delivered over the telephone
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Secondary outcomes included 30-day point prevalence abstinence and prolonged abstinence (>6 months).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry A. Dent, Pharm.D.
Organizational Affiliation
The University of Montana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Missoula VA Clinic
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Randomized Trial Assessing the Effectiveness of a Pharmacist-Delivered Program for Smoking Cessation
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