NCT00670904

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2008

Completed
Last Updated

January 12, 2010

Status Verified

April 1, 2008

Enrollment Period

2.1 years

First QC Date

April 30, 2008

Last Update Submit

January 11, 2010

Conditions

Tobacco Use DisorderSmoking

Keywords

Smoking cessationPharmacist-delivered

Outcome Measures

Primary Outcomes (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 Outcomes (1)

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

    6 months

Study Arms (2)

1

ACTIVE COMPARATOR

Pharmacist-delivered group program for smoking cession.

Other: Pharmacist-delivered group program for smoking cessation

2

PLACEBO COMPARATOR

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

Other: Brief standard care session for smoking cessation delivered over the telephone

Interventions

Pharmacist-delivered group program for smoking cessationOTHER

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.

1
Brief standard care session for smoking cessation delivered over the telephoneOTHER

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.

2

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Missoula VA Clinic

Missoula, Montana, 59808, United States

Location

MeSH Terms

Conditions

Tobacco Use DisorderSmokingSmoking Cessation

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehaviorHealth Behavior

Study Officials

  • Larry A. Dent, Pharm.D.

    The University of Montana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 30, 2008

First Posted

May 2, 2008

Study Start

October 1, 2005

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

January 12, 2010

Record last verified: 2008-04

Locations

US(1)