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

NCT ID: NCT00670904

Last Updated: 2010-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2007-11-30

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.

Conditions

Tobacco Use Disorder; Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Pharmacist-delivered group program for smoking cession.

Group Type: ACTIVE_COMPARATOR

Pharmacist-delivered group program for smoking cessation

Intervention Type: OTHER

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.

2

Brief standard care session for tobacco smoking cessation delivered over the telephone.

Group Type: PLACEBO_COMPARATOR

Brief standard care session for smoking cessation delivered over the telephone

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Prevent Cancer Foundation

OTHER

Sponsor Role: collaborator

University of Montana

OTHER

Sponsor Role: lead

Responsible Party

The University of Montana

Principal Investigators

Larry A. Dent, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Montana

Locations

Missoula VA Clinic

Missoula, Montana, United States

Countries

United States

Other Identifiers

M29670

Identifier Type: -

Identifier Source: org_study_id