Tobacco Use DisorderNCT00670904
Randomized Trial Assessing the Effectiveness of a Pharmacist-Delivered Program for Smoking Cessation
A study testing Pharmacist-delivered group program for smoking cessation in people with Tobacco Use Disorder and Smoking, run by University of Montana at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder, Smoking
- What is being tested?
- Pharmacist-delivered group program for smoking cessation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Nov 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Pharmacist-delivered group program for smoking cessation, Brief standard care session for smoking cessation delivered over the telephone
- Keywords
- Smoking cessation, Pharmacist-delivered
- Medical subject headings
- Tobacco Use Disorder, Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Pharmacist-delivered group program for smoking cession. Receives: Other: Pharmacist-delivered group program for smoking cessation |
| 2 | Placebo comparator | Brief standard care session for tobacco smoking cessation delivered over the telephone. Receives: Other: Brief standard care session for smoking cessation delivered over the telephone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Secondary outcomes included 30-day point prevalence abstinence and prolonged abstinence (>6 months).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2008 (estimated)
- Study startOct 2005
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Montana
- Sponsor type
- University, hospital or other
- Collaborators
- Prevent Cancer Foundation
- Investigators
- Larry A. Dent, Pharm.D., Principal investigator, The University of Montana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670904
- Sponsor's protocol ID
- M29670
- Status last verified
- Apr 2008
- First submitted
- 30 Apr 2008
- Last updated
- 12 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Assessing the Effectiveness of a Pharmacist-Delivered Program for Smoking Cessation
- ClinicalTrials.gov ID
- NCT00670904
- Acronym / sponsor ID
- M29670
- Conditions
- Tobacco Use Disorder, Smoking
- Keywords
- Smoking cessation, Pharmacist-delivered
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of MontanaUniversity, hospital or other
- Collaborators
- Prevent Cancer Foundation
- Study start
- Oct 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 2 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Pharmacist-delivered group program for smoking cessationPharmacist-delivered group program for smoking cession. |
| 2 | Placebo comparator | Other: Brief standard care session for smoking cessation delivered over the telephoneBrief standard care session for tobacco smoking cessation delivered over the telephone. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist-delivered group program for smoking cessationParticipants 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. | Other | 1 |
| Brief standard care session for smoking cessation delivered over the telephoneThose 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. | Other | 2 |
Primary outcome
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
1 secondary outcome
Secondary outcomes included 30-day point prevalence abstinence and prolonged abstinence (>6 months).
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larry A. Dent, Pharm.D. principal investigator
The University of Montana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist-delivered group program for smoking cessation in people with Tobacco Use Disorder and Smoking, run by University of Montana at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2010.