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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00670904
First Posted: May 2, 2008
Last Update Posted: January 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Prevent Cancer Foundation
Information provided by:
University of Montana
  Purpose
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.

Condition Intervention
Tobacco Use Disorder Smoking Other: Pharmacist-delivered group program for smoking cessation Other: Brief standard care session for smoking cessation delivered over the telephone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial Assessing the Effectiveness of a Pharmacist-Delivered Program for Smoking Cessation

Resource links provided by NLM:


Further study details as provided by University of Montana:

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. [ Time Frame: 6 months ]

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

Enrollment: 101
Study Start Date: October 2005
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00670904


Locations
United States, Montana
Missoula VA Clinic
Missoula, Montana, United States, 59808
Sponsors and Collaborators
University of Montana
Prevent Cancer Foundation
Investigators
Principal Investigator: Larry A. Dent, Pharm.D. The University of Montana
  More Information

Responsible Party: Larry A. Dent, The University of Montana
ClinicalTrials.gov Identifier: NCT00670904     History of Changes
Other Study ID Numbers: M29670
First Submitted: April 30, 2008
First Posted: May 2, 2008
Last Update Posted: January 12, 2010
Last Verified: April 2008

Keywords provided by University of Montana:
Smoking cessation
Pharmacist-delivered

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders