Tobacco Use CessationNCT01123967
Offering Proactive Tobacco Treatment
A study testing proactive outreach (PRO), telephone counseling (TC) and Nicotine replacement therapy (NRT) in people with Tobacco Use Cessation, run by University of Minnesota at 1 site in United States.
Trial summary
This study uses a proactive outreach strategy, coupled with free nicotine replacement therapy (NRT) to increase the population impact of tobacco cessation treatment for diverse, low income smokers. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- proactive outreach (PRO), telephone counseling (TC) and Nicotine replacement therapy (NRT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Aug 2014
- 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must complete the baseline survey
- Current self-reported cigarette smoker
- Has a valid home address
- An adequate proficiency in English to complete study surveys and participate in telephone counseling.
Who cannot join
- adult smokers not enrolled in the Minnesota Health Care Programs (MHCP).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improved Effectiveness of Smoking Cessation Programs for Minnesota Priority Populations
This study uses a proactive outreach strategy, coupled with free nicotine replacement therapy (NRT) to increase the population impact of tobacco cessation treatment for diverse, low income smokers. Population impact is the product of treatment utilization (i.e., reach or exposure) and treatment efficacy (i.e., smoking abstinence rates among those who utilize treatment).
Read the detailed description
Participants will be randomized to receive either Usual (Reactive) Care or Proactive Outreach, Telephone Counseling and free nicotine replacement therapy (NRT).
- Conditions
- Tobacco Use Cessation
- Being tested
- proactive outreach (PRO), telephone counseling (TC), Nicotine replacement therapy (NRT), Usual care (UC)
- Keywords
- nicotine replacement therapy, smoking cessation, tobacco dependent
- Medical subject headings
- Tobacco Use Cessation, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proactive outreach (PRO)Other
a mailed invitation letter followed by telephone outreach
telephone counseling (TC)Other
free telephone counseling
Nicotine replacement therapy (NRT)Other
free nicotine replacement therapy (NRT)
Usual care (UC)Other
nicotine replacement products (patch, gum, lozenge, inhaler, and nasal spray)
| Study group | Role | What they receive |
|---|---|---|
| PRO+NRT+TC | Experimental | Proactive outreach (mailed invitation letter followed by telephone outreach) combined with free nicotine replacement therapy (NRT) and telephone counseling (PRO+NRT+TC)to usual care (UC) Receives: Other: proactive outreach (PRO); Other: telephone counseling (TC); Other: Nicotine replacement therapy (NRT) |
| Usual Care (UC) | Active comparator | Usual (standard) care - Smoking cessation products: patch, gum, lozenge, inhaler and nasal spray Receives: Other: Usual care (UC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results in Abstinence Rates
Compare the effect of proactive outreach combined with free NRT and telephone counseling (PRO+NRT+TC) to usual care (UC) on population-level smoking abstinence rates among a diverse population of low income smokers.
Measured: 1 Year
Secondary outcomes (2)
Results in Treatment Utilization
Compare the effect of proactive outreach combined with free NRT and telephone counseling (PRO+NRT+TC) to usual care (UC) on population-level tobacco treatment utilization rates among a diverse population of low income smokers.
Measured: 1 Year
Cost-Effectiveness of Program
Determine the cost-effectiveness of PRO+NRT+TC compared with UC.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startFeb 2011
- Primary completionFeb 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use CessationStudies 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
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Steven Fu, M.D., Principal investigator, Veterans Administration HospitalAnne Joseph, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123967
- Sponsor's protocol ID
- 2009NTLS064
- Other IDs
- 0909S72235, 1R01CA141527
- Status last verified
- May 2015
- First submitted
- 12 May 2010
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hammett PJ, Japuntich SJ, Sherman SE, Rogers ES, Danan ER, Noorbaloochi S, El-Shahawy O, Burgess DJ, Fu SS. Proactive tobacco treatment for veterans with posttraumatic stress disorder. Psychol Trauma. 2021 Jan;13(1):114-122. doi: 10.1037/tra0000613. Epub 2020 Jul 2.
PubMed 32614201Hammett PJ, Lando HA, Erickson DJ, Widome R, Taylor BC, Nelson D, Japuntich SJ, Fu SS. Proactive outreach tobacco treatment for socioeconomically disadvantaged smokers with serious mental illness. J Behav Med. 2020 Jun;43(3):493-502. doi: 10.1007/s10865-019-00083-8. Epub 2019 Jul 30.
PubMed 31363948Fu SS, van Ryn M, Nelson D, Burgess DJ, Thomas JL, Saul J, Clothier B, Nyman JA, Hammett P, Joseph AM. Proactive tobacco treatment offering free nicotine replacement therapy and telephone counselling for socioeconomically disadvantaged smokers: a randomised clinical trial. Thorax. 2016 May;71(5):446-53. doi: 10.1136/thoraxjnl-2015-207904. Epub 2016 Mar 1.
PubMed 26931362Fu SS, van Ryn M, Burgess DJ, Nelson D, Clothier B, Thomas JL, Nyman JA, Joseph AM. Proactive tobacco treatment for low income smokers: study protocol of a randomized controlled trial. BMC Public Health. 2014 Apr 9;14:337. doi: 10.1186/1471-2458-14-337.
PubMed 24716466
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Effectiveness of Smoking Cessation Programs for Minnesota Priority Populations
- ClinicalTrials.gov ID
- NCT01123967
- Acronym / sponsor ID
- 2009NTLS064
- Conditions
- Tobacco Use Cessation
- Keywords
- nicotine replacement therapy, smoking cessation, tobacco dependent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 14 May 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.
This study uses a proactive outreach strategy, coupled with free nicotine replacement therapy (NRT) to increase the population impact of tobacco cessation treatment for diverse, low income smokers. Population impact is the product of treatment utilization (i.e., reach or exposure) and treatment efficacy (i.e., smoking abstinence rates among those who utilize treatment).
Detailed description
Participants will be randomized to receive either Usual (Reactive) Care or Proactive Outreach, Telephone Counseling and free nicotine replacement therapy (NRT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRO+NRT+TC | Experimental | Other: proactive outreach (PRO), Other: telephone counseling (TC), Other: Nicotine replacement therapy (NRT)Proactive outreach (mailed invitation letter followed by telephone outreach) combined with free nicotine replacement therapy (NRT) and telephone counseling (PRO+NRT+TC)to usual care (UC) |
| Usual Care (UC) | Active comparator | Other: Usual care (UC)Usual (standard) care - Smoking cessation products: patch, gum, lozenge, inhaler and nasal spray |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Must complete the baseline survey
- Current self-reported cigarette smoker
- Has a valid home address
- An adequate proficiency in English to complete study surveys and participate in telephone counseling.
Key exclusion criteria (1 listed)
- adult smokers not enrolled in the Minnesota Health Care Programs (MHCP).
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 |
|---|---|---|
| proactive outreach (PRO)a mailed invitation letter followed by telephone outreach | Other | PRO+NRT+TC |
| telephone counseling (TC)free telephone counseling | Other | PRO+NRT+TC |
| Nicotine replacement therapy (NRT)free nicotine replacement therapy (NRT) | Other | PRO+NRT+TC |
| Usual care (UC)nicotine replacement products (patch, gum, lozenge, inhaler, and nasal spray) | Other | Usual Care (UC) |
Primary outcome
Results in Abstinence Rates
Time frame: 1 Year
Compare the effect of proactive outreach combined with free NRT and telephone counseling (PRO+NRT+TC) to usual care (UC) on population-level smoking abstinence rates among a diverse population of low income smokers.
2 secondary outcomes
Results in Treatment Utilization
Time frame: 1 Year
Cost-Effectiveness of Program
Time frame: 1 Year
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 27 May 2015.
- Derived from this study: PubMed 32614201Hammett PJ, Japuntich SJ, Sherman SE, Rogers ES, Danan ER, Noorbaloochi S, El-Shahawy O, Burgess DJ, Fu SS. Proactive tobacco treatment for veterans with posttraumatic stress disorder. Psychol Trauma. 2021 Jan;13(1):114-122. doi: 10.1037/tra0000613. Epub 2020 Jul 2.
- Derived from this study: PubMed 31363948Hammett PJ, Lando HA, Erickson DJ, Widome R, Taylor BC, Nelson D, Japuntich SJ, Fu SS. Proactive outreach tobacco treatment for socioeconomically disadvantaged smokers with serious mental illness. J Behav Med. 2020 Jun;43(3):493-502. doi: 10.1007/s10865-019-00083-8. Epub 2019 Jul 30.
- Derived from this study: PubMed 26931362Fu SS, van Ryn M, Nelson D, Burgess DJ, Thomas JL, Saul J, Clothier B, Nyman JA, Hammett P, Joseph AM. Proactive tobacco treatment offering free nicotine replacement therapy and telephone counselling for socioeconomically disadvantaged smokers: a randomised clinical trial. Thorax. 2016 May;71(5):446-53. doi: 10.1136/thoraxjnl-2015-207904. Epub 2016 Mar 1.
- Derived from this study: PubMed 24716466Fu SS, van Ryn M, Burgess DJ, Nelson D, Clothier B, Thomas JL, Nyman JA, Joseph AM. Proactive tobacco treatment for low income smokers: study protocol of a randomized controlled trial. BMC Public Health. 2014 Apr 9;14:337. doi: 10.1186/1471-2458-14-337.
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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.
Steven Fu, M.D. principal investigator
Veterans Administration Hospital
Anne Joseph, MD principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing proactive outreach (PRO), telephone counseling (TC) and Nicotine replacement therapy (NRT) in people with Tobacco Use Cessation, run by University of Minnesota 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 1 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 27 May 2015. 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.
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?
Results in Abstinence Rates (time frame: 1 Year). 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 NCT01123967, which also lists 4 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 27 May 2015.