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

This study has been completed.
Sponsor:
Collaborator:
Prevent Cancer Foundation
Information provided by:
University of Montana
ClinicalTrials.gov Identifier:
NCT00670904
First received: April 30, 2008
Last updated: January 11, 2010
Last verified: April 2008
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcomes included 30-day point prevalence abstinence and prolonged abstinence (>6 months). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Larry A. Dent, The University of Montana
ClinicalTrials.gov Identifier: NCT00670904     History of Changes
Other Study ID Numbers: M29670
Study First Received: April 30, 2008
Last Updated: January 11, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Smoking
Tobacco Use Disorder
Habits
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013