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

Sponsor
University of Montana (Other)
Overall Status
Completed
CT.gov ID
NCT00670904
Collaborator
Prevent Cancer Foundation (Other)
101
1
2
25
4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pharmacist-delivered group program for smoking cessation
  • Other: Brief standard care session for smoking cessation delivered over the telephone
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
101 participants
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
Study Start Date :
Oct 1, 2005
Actual Primary Completion Date :
Nov 1, 2007
Actual Study Completion Date :
Nov 1, 2007

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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. [6 months]

Secondary Outcome Measures

  1. Secondary outcomes included 30-day point prevalence abstinence and prolonged abstinence (>6 months). [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00670904
Other Study ID Numbers:
  • M29670
First Posted:
May 2, 2008
Last Update Posted:
Jan 12, 2010
Last Verified:
Apr 1, 2008
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 12, 2010