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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00670904
• Other study ID #: M29670
• Status: Completed
• Phase: N/A
• First received: April 30, 2008
• Last updated: January 11, 2010
• Start date: October 2005
• Est. completion date: November 2007

Study information

• Verified date: April 2008
• Source: University of Montana
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking
• Tobacco Use Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Missoula VA Clinic	Missoula	Montana

Sponsors (2)

Lead Sponsor	Collaborator
University of Montana	Prevent Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Secondary outcomes included 30-day point prevalence abstinence and prolonged abstinence (>6 months).		6 months	No