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

January 11, 2010 updated by: University of Montana
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Montana
      • Missoula, Montana, United States, 59808
        • Missoula VA Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Pharmacist-delivered group program for smoking cession.
Other: Pharmacist-delivered group program for smoking cessation
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.
Placebo Comparator: 2
Brief standard care session for tobacco smoking cessation delivered over the telephone.
Other: Brief standard care session for smoking cessation delivered over the telephone
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Montana

Collaborators

Prevent Cancer Foundation

Investigators

  • Principal Investigator: Larry A. Dent, Pharm.D., The University of Montana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

April 30, 2008

First Submitted That Met QC Criteria

May 1, 2008

First Posted (Estimate)

May 2, 2008

Study Record Updates

Last Update Posted (Estimate)

January 12, 2010

Last Update Submitted That Met QC Criteria

January 11, 2010

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M29670

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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