search
Back to results

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
University of Montana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring Smoking cessation, Pharmacist-delivered

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
April 30, 2008
Last Updated
January 11, 2010
Sponsor
University of Montana
Collaborators
Prevent Cancer Foundation
search

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

We'll reach out to this number within 24 hrs