SmokingPhase 3NCT01188018
Testing Counseling Styles to Motivate Smokers to Quit
A Phase 3 study testing Brief Advice (BA), Motivational Interviewing (MI) and Health Education (HE) in people with Smoking and Tobacco Use, run by University of Missouri, Kansas City at 1 site in United States.
Trial summary
The purpose of this study is to determine, among a sample of general adult smokers, the effectiveness of three different counseling interventions for motivating quit attempts among smokers not yet ready to quit. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Tobacco Use, Nicotine Dependence
- What is being tested?
- Brief Advice (BA), Motivational Interviewing (MI) and Health Education (HE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jun 2012
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years and older
- Smoke at least once a day for the past 30 days
- Are willing to participate in all study components
- Sufficient language skills in English for counseling and assessments
- Has a home address
- Has a working phone number
Who cannot join
- Pregnant or planning to become pregnant in the next 6 months
- Currently using a smoking cessation medication
- Currently participating in smoking cessation program
- Motivated to quit smoking
- Planning to quit smoking in the next 2 weeks
- Lives in a home with someone currently enrolled in the study
- Minor
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri-Kansas City
Kansas City, Missouri, 64110
About this study
Official title: Can Motivational Interviewing be Effective for Smoking Cessation?
The purpose of this study is to determine, among a sample of general adult smokers, the effectiveness of three different counseling interventions for motivating quit attempts among smokers not yet ready to quit.
- Conditions
- Smoking, Tobacco Use, Nicotine Dependence
- Being tested
- Brief Advice (BA), Motivational Interviewing (MI), Health Education (HE)
- Keywords
- Smoking, Smoking Cessation, Nicotine Dependence, Tobacco Use Cessation, Health Education, Patient Education
- Medical subject headings
- Smoking, Tobacco Use, Tobacco Use Disorder, Smoking Cessation, Tobacco Use Cessation, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Advice (BA)Behavioural
Participants in this arm will receive a single session of brief advice. A counselor will briefly discuss the risks associated with smoking.
Motivational Interviewing (MI)Behavioural
Subjects will receive 4 counseling sessions (over 18 weeks) in which their thoughts about their smoking will be discussed. Two of these counseling sessions will be performed in person (weeks 0 and 12) and the remaining two will be over the phone(weeks 6 and 18).
Health Education (HE)Behavioural
Subjects will receive 4 counseling sessions (over 18 weeks)in which they will receive educational information about the risks of smoking and the benefits of quitting. Two of these counseling sessions will be performed in person (weeks 0 and 12) and the remaining two will be over the phone (weeks 6 and 18).
| Study group | Role | What they receive |
|---|---|---|
| Brief Advice | Active comparator | Not described Receives: Behavioral: Brief Advice (BA) |
| Motivational Interviewing | Experimental | Not described Receives: Behavioral: Motivational Interviewing (MI) |
| Health Education | Active comparator | Not described Receives: Behavioral: Health Education (HE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quit Attempt(s)
Measured: Any time within 26 weeks
Secondary outcomes (1)
Smoking Cessation
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Delwyn Catley, University of Missouri, Kansas City
- Investigators
- Delwyn Catley, Ph.D., Principal investigator, University of Missouri, Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188018
- Sponsor's protocol ID
- 00023726
- Other IDs
- 1R01CA133068-01A2
- Status last verified
- Jul 2012
- First submitted
- 24 Aug 2010
- Last updated
- 4 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
2008 PHS Guideline Update Panel, Liaisons, and Staff. Treating tobacco use and dependence: 2008 update U.S. Public Health Service Clinical Practice Guideline executive summary. Respir Care. 2008 Sep;53(9):1217-22. No abstract available.
PubMed 18807274Soria R, Legido A, Escolano C, Lopez Yeste A, Montoya J. A randomised controlled trial of motivational interviewing for smoking cessation. Br J Gen Pract. 2006 Oct;56(531):768-74.
PubMed 17007707Hettema J, Steele J, Miller WR. Motivational interviewing. Annu Rev Clin Psychol. 2005;1:91-111. doi: 10.1146/annurev.clinpsy.1.102803.143833.
PubMed 17716083Grobe JE, Goggin K, Harris KJ, Richter KP, Resnicow K, Catley D. Race moderates the effects of Motivational Interviewing on smoking cessation induction. Patient Educ Couns. 2020 Feb;103(2):350-358. doi: 10.1016/j.pec.2019.08.023. Epub 2019 Aug 18.
PubMed 31466882Bani-Yaghoub M, Elhomani A, Catley D. Effectiveness of motivational interviewing, health education and brief advice in a population of smokers who are not ready to quit. BMC Med Res Methodol. 2018 Jun 13;18(1):52. doi: 10.1186/s12874-018-0511-0.
PubMed 29895280Harris KJ, Bradley-Ewing A, Goggin K, Richter KP, Patten C, Williams K, Lee HS, Staggs VS, Catley D. Recruiting unmotivated smokers into a smoking induction trial. Health Educ Res. 2016 Jun;31(3):363-74. doi: 10.1093/her/cyw018. Epub 2016 Apr 13.
PubMed 27081187Catley D, Goggin K, Harris KJ, Richter KP, Williams K, Patten C, Resnicow K, Ellerbeck EF, Bradley-Ewing A, Lee HS, Moreno JL, Grobe JE. A Randomized Trial of Motivational Interviewing: Cessation Induction Among Smokers With Low Desire to Quit. Am J Prev Med. 2016 May;50(5):573-583. doi: 10.1016/j.amepre.2015.10.013. Epub 2015 Dec 23.
PubMed 26711164Catley D, Harris KJ, Goggin K, Richter K, Williams K, Patten C, Resnicow K, Ellerbeck E, Bradley-Ewing A, Malomo D, Liston R. Motivational Interviewing for encouraging quit attempts among unmotivated smokers: study protocol of a randomized, controlled, efficacy trial. BMC Public Health. 2012 Jun 19;12:456. doi: 10.1186/1471-2458-12-456.
PubMed 22713093
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Motivational Interviewing be Effective for Smoking Cessation?
- ClinicalTrials.gov ID
- NCT01188018
- Acronym / sponsor ID
- 00023726
- Conditions
- Smoking, Tobacco Use, Nicotine Dependence
- Keywords
- Smoking, Smoking Cessation, Nicotine Dependence, Tobacco Use Cessation, Health Education, Patient Education
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 25 Aug 2010 (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.
The purpose of this study is to determine, among a sample of general adult smokers, the effectiveness of three different counseling interventions for motivating quit attempts among smokers not yet ready to quit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brief Advice | Active comparator | Behavioral: Brief Advice (BA) |
| Motivational Interviewing | Experimental | Behavioral: Motivational Interviewing (MI) |
| Health Education | Active comparator | Behavioral: Health Education (HE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years and older
- Smoke at least once a day for the past 30 days
- Are willing to participate in all study components
- Sufficient language skills in English for counseling and assessments
- Has a home address
Key exclusion criteria (7 listed)
- Pregnant or planning to become pregnant in the next 6 months
- Currently using a smoking cessation medication
- Currently participating in smoking cessation program
- Motivated to quit smoking
- Planning to quit smoking in the next 2 weeks
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 |
|---|---|---|
| Brief Advice (BA)Participants in this arm will receive a single session of brief advice. A counselor will briefly discuss the risks associated with smoking. | Behavioural | Brief Advice |
| Motivational Interviewing (MI)Subjects will receive 4 counseling sessions (over 18 weeks) in which their thoughts about their smoking will be discussed. Two of these counseling sessions will be performed in person (weeks 0 and 12) and the remaining two will be over the phone(weeks 6 and 18). | Behavioural | Motivational Interviewing |
| Health Education (HE)Subjects will receive 4 counseling sessions (over 18 weeks)in which they will receive educational information about the risks of smoking and the benefits of quitting. Two of these counseling sessions will be performed in person (weeks 0 and 12) and the remaining two will be over the phone (weeks 6 and 18). | Behavioural | Health Education |
Primary outcome
Quit Attempt(s)
Time frame: Any time within 26 weeks
1 secondary outcome
Smoking Cessation
Time frame: 7 days
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 4 Jul 2012.
- Background: PubMed 188072742008 PHS Guideline Update Panel, Liaisons, and Staff. Treating tobacco use and dependence: 2008 update U.S. Public Health Service Clinical Practice Guideline executive summary. Respir Care. 2008 Sep;53(9):1217-22. No abstract available.
- Background: PubMed 17007707Soria R, Legido A, Escolano C, Lopez Yeste A, Montoya J. A randomised controlled trial of motivational interviewing for smoking cessation. Br J Gen Pract. 2006 Oct;56(531):768-74.
- Background: PubMed 17716083Hettema J, Steele J, Miller WR. Motivational interviewing. Annu Rev Clin Psychol. 2005;1:91-111. doi: 10.1146/annurev.clinpsy.1.102803.143833.
- Derived from this study: PubMed 31466882Grobe JE, Goggin K, Harris KJ, Richter KP, Resnicow K, Catley D. Race moderates the effects of Motivational Interviewing on smoking cessation induction. Patient Educ Couns. 2020 Feb;103(2):350-358. doi: 10.1016/j.pec.2019.08.023. Epub 2019 Aug 18.
- Derived from this study: PubMed 29895280Bani-Yaghoub M, Elhomani A, Catley D. Effectiveness of motivational interviewing, health education and brief advice in a population of smokers who are not ready to quit. BMC Med Res Methodol. 2018 Jun 13;18(1):52. doi: 10.1186/s12874-018-0511-0.
- Derived from this study: PubMed 27081187Harris KJ, Bradley-Ewing A, Goggin K, Richter KP, Patten C, Williams K, Lee HS, Staggs VS, Catley D. Recruiting unmotivated smokers into a smoking induction trial. Health Educ Res. 2016 Jun;31(3):363-74. doi: 10.1093/her/cyw018. Epub 2016 Apr 13.
- Derived from this study: PubMed 26711164Catley D, Goggin K, Harris KJ, Richter KP, Williams K, Patten C, Resnicow K, Ellerbeck EF, Bradley-Ewing A, Lee HS, Moreno JL, Grobe JE. A Randomized Trial of Motivational Interviewing: Cessation Induction Among Smokers With Low Desire to Quit. Am J Prev Med. 2016 May;50(5):573-583. doi: 10.1016/j.amepre.2015.10.013. Epub 2015 Dec 23.
- Derived from this study: PubMed 22713093Catley D, Harris KJ, Goggin K, Richter K, Williams K, Patten C, Resnicow K, Ellerbeck E, Bradley-Ewing A, Malomo D, Liston R. Motivational Interviewing for encouraging quit attempts among unmotivated smokers: study protocol of a randomized, controlled, efficacy trial. BMC Public Health. 2012 Jun 19;12:456. doi: 10.1186/1471-2458-12-456.
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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.
Delwyn Catley, Ph.D. principal investigator
University of Missouri, Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brief Advice (BA), Motivational Interviewing (MI) and Health Education (HE) in people with Smoking and Tobacco Use, run by University of Missouri, Kansas City 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 6 inclusion and 7 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 4 Jul 2012. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quit Attempt(s) (time frame: Any time within 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01188018, which also lists 8 linked publications.
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 4 Jul 2012.