Tobacco Use CessationPhase 4NCT02721082
Changing the Default for Tobacco Treatment
A Phase 4 study testing Opt Out Treatment Program, Nicotine Replacement Therapy and Opt In Treatment Program in people with Tobacco Use Cessation, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the impact and efficacy of a new approach to smoking cessation treatment versus the traditional approach. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- Opt Out Treatment Program, Nicotine Replacement Therapy and Opt In Treatment Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to 9 Dec 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Speak English or Spanish
- Have access to a telephone or mobile phone
- Not be currently pregnant or breast feeding
- Have no significant co-morbidity that precludes participation
- Current daily smoker
- Not in treatment for tobacco dependence
- Reside in Kansas or Missouri
Who cannot join
- Admission greater than 3 days
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The purpose of this study is to determine the impact and efficacy of a new approach to smoking cessation treatment versus the traditional approach.
Read the detailed description
In many health conditions, the default treatment approach is to first identify the health condition and then begin treatment. In this scenario, the physician discusses treatment options with the patient. The patient is free to decline treatment as they wish. If patients do nothing though, they will receive care.
For tobacco users, the default treatment is for them to "opt in" to receive smoking cessation assistance. The provider asks the smoker if they are ready to quit, and they offer medication and support only to those who respond back "yes". This limits the amount of smokers that receive treatment because only 1 in 3 smokers say they are ready to quit.
This study is looking at a novel approach to smoking cessation treatment. This study will compare the traditional, "standard of care" approach to opting in against a new approach where all smokers are provided with cessation medication and counseling unless they refuse it.
- Conditions
- Tobacco Use Cessation
- Being tested
- Opt Out Treatment Program, Nicotine Replacement Therapy, Opt In Treatment Program
- Keywords
- tobacco treatment
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opt Out Treatment ProgramBehavioural
Tobacco Treatment (UKanQuit) staff will complete a treatment plan for all participants.
Nicotine Replacement TherapyDrug
Also called Nicotine patch, Nicotine mini-lozenges, Nicotine gum
Unless they Opt Out all participants will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
Opt In Treatment ProgramBehavioural
Tobacco Treatment (UKanQuit) staff will complete a treatment plan for participant's who are ready to quit smoking. For patient's not ready to quit, motivational counseling will be provided to participants based on principles of Motivational Interviewing.
Nicotine Replacement TherapyDrug
Also called Nicotine patch, Nicotine mini-lozenges, Nicotine gum
Participants ready to quit will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
| Study group | Role | What they receive |
|---|---|---|
| Opt Out | Experimental | Participants in this arm will be first enrolled to receive cessation treatment and will only not receive it by "opting out". Participant will receive a Opt Out treatment program. Participants will receive counseling and nicotine replacement therapy. Receives: Behavioral: Opt Out Treatment Program; Drug: Nicotine Replacement Therapy |
| Opt In | Active comparator | Traditional approach to tobacco treatment program. Participants must first indicate they are ready to quit smoking by "opting in" to receive Opt In treatment program. Receives: Behavioral: Opt In Treatment Program; Drug: Nicotine Replacement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day Point-prevalence Abstinence
7-day, self-reported and verified cigarette abstinence.
Measured: Month 1
Secondary outcomes (3)
Treatment Engagement
Percentages of participants who use cessation medications and participate in counseling post discharge
Measured: Month 1
Default-theory Based Measures
We will assess the impact of opt-out versus opt-in treatment on perceived treatment coercion using items adapted from the Admission Experience Survey (AES) short form.
Measured: Month 1
7-day Point-prevalence Abstinence
7-day, self-reported and verified cigarette abstinence.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2016 (estimated)
- Study start1 Sep 2016
- Primary completion27 Jul 2020
- Study completion9 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Kimber Richter, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721082
- Sponsor's protocol ID
- STUDY00001774
- Other IDs
- R01HL131512
- Status last verified
- Nov 2022
- First submitted
- 22 Mar 2016
- Last updated
- 1 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Richter KP, Catley D, Gajewski BJ, Faseru B, Shireman TI, Zhang C, Scheuermann TS, Mussulman LM, Nazir N, Hutcheson T, Shergina E, Ellerbeck EF. The Effects of Opt-out vs Opt-in Tobacco Treatment on Engagement, Cessation, and Costs: A Randomized Clinical Trial. JAMA Intern Med. 2023 Apr 1;183(4):331-339. doi: 10.1001/jamainternmed.2022.7170.
PubMed 36848129Faseru B, Mussulman LM, Nazir N, Ellerbeck EF, Shergina E, Scheuermann TS, Gajewski BJ, Catley D, Richter KP. Use of pre-enrollment randomization and delayed consent to maximize participation in a clinical trial of opt-in versus opt-out tobacco treatment. Subst Abus. 2022;43(1):1035-1042. doi: 10.1080/08897077.2022.2060441.
PubMed 35435813Faseru B, Ellerbeck EF, Catley D, Gajewski BJ, Scheuermann TS, Shireman TI, Mussulman LM, Nazir N, Bush T, Richter KP. Changing the default for tobacco-cessation treatment in an inpatient setting: study protocol of a randomized controlled trial. Trials. 2017 Aug 14;18(1):379. doi: 10.1186/s13063-017-2119-9.
PubMed 28806908
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing the Default for Tobacco Treatment
- ClinicalTrials.gov ID
- NCT02721082
- Acronym / sponsor ID
- STUDY00001774
- Conditions
- Tobacco Use Cessation
- Keywords
- tobacco treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 27 Jul 2020 (actual)
- Study completion
- 9 Dec 2020 (actual)
- First posted
- 28 Mar 2016 (estimated)
- Results
- Posted 1 Dec 2022
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 the impact and efficacy of a new approach to smoking cessation treatment versus the traditional approach.
Detailed description
In many health conditions, the default treatment approach is to first identify the health condition and then begin treatment. In this scenario, the physician discusses treatment options with the patient. The patient is free to decline treatment as they wish. If patients do nothing though, they will receive care.
For tobacco users, the default treatment is for them to "opt in" to receive smoking cessation assistance. The provider asks the smoker if they are ready to quit, and they offer medication and support only to those who respond back "yes". This limits the amount of smokers that receive treatment because only 1 in 3 smokers say they are ready to quit.
This study is looking at a novel approach to smoking cessation treatment. This study will compare the traditional, "standard of care" approach to opting in against a new approach where all smokers are provided with cessation medication and counseling unless they refuse it.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opt Out | Experimental | Behavioral: Opt Out Treatment Program, Drug: Nicotine Replacement TherapyParticipants in this arm will be first enrolled to receive cessation treatment and will only not receive it by "opting out". Participant will receive a Opt Out treatment program. Participants will receive counseling and nicotine replacement therapy. |
| Opt In | Active comparator | Behavioral: Opt In Treatment Program, Drug: Nicotine Replacement TherapyTraditional approach to tobacco treatment program. Participants must first indicate they are ready to quit smoking by "opting in" to receive Opt In treatment program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Speak English or Spanish
- Have access to a telephone or mobile phone
- Not be currently pregnant or breast feeding
- Have no significant co-morbidity that precludes participation
- Current daily smoker
Key exclusion criteria (1 listed)
- Admission greater than 3 days
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 |
|---|---|---|
| Opt Out Treatment ProgramTobacco Treatment (UKanQuit) staff will complete a treatment plan for all participants. | Behavioural | Opt Out |
| Nicotine Replacement TherapyAlso: Nicotine patch, Nicotine mini-lozenges, Nicotine gumUnless they Opt Out all participants will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria. | Drug | Opt Out |
| Opt In Treatment ProgramTobacco Treatment (UKanQuit) staff will complete a treatment plan for participant's who are ready to quit smoking. For patient's not ready to quit, motivational counseling will be provided to participants based on principles of Motivational Interviewing. | Behavioural | Opt In |
| Nicotine Replacement TherapyAlso: Nicotine patch, Nicotine mini-lozenges, Nicotine gumParticipants ready to quit will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria. | Drug | Opt In |
Primary outcome
7-day Point-prevalence Abstinence
Time frame: Month 1
7-day, self-reported and verified cigarette abstinence.
3 secondary outcomes
Treatment Engagement
Time frame: Month 1
Default-theory Based Measures
Time frame: Month 1
7-day Point-prevalence Abstinence
Time frame: Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36848129Richter KP, Catley D, Gajewski BJ, Faseru B, Shireman TI, Zhang C, Scheuermann TS, Mussulman LM, Nazir N, Hutcheson T, Shergina E, Ellerbeck EF. The Effects of Opt-out vs Opt-in Tobacco Treatment on Engagement, Cessation, and Costs: A Randomized Clinical Trial. JAMA Intern Med. 2023 Apr 1;183(4):331-339. doi: 10.1001/jamainternmed.2022.7170.
- Derived from this study: PubMed 35435813Faseru B, Mussulman LM, Nazir N, Ellerbeck EF, Shergina E, Scheuermann TS, Gajewski BJ, Catley D, Richter KP. Use of pre-enrollment randomization and delayed consent to maximize participation in a clinical trial of opt-in versus opt-out tobacco treatment. Subst Abus. 2022;43(1):1035-1042. doi: 10.1080/08897077.2022.2060441.
- Derived from this study: PubMed 28806908Faseru B, Ellerbeck EF, Catley D, Gajewski BJ, Scheuermann TS, Shireman TI, Mussulman LM, Nazir N, Bush T, Richter KP. Changing the default for tobacco-cessation treatment in an inpatient setting: study protocol of a randomized controlled trial. Trials. 2017 Aug 14;18(1):379. doi: 10.1186/s13063-017-2119-9.
- Individual participant dataSharing planned: No
Related trials for Tobacco Use Cessation
Active, not recruitingPhase 3
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Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
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Developing a Scalable Tobacco Cessation Program for Cancer Survivors and Caregivers
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Adaptation and Testing of a Novel Text-based Tobacco Cessation and Education Intervention in Kenyan Emergency Department Patients
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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.
Kimber Richter, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Opt Out Treatment Program, Nicotine Replacement Therapy and Opt In Treatment Program in people with Tobacco Use Cessation, run by University of Kansas Medical Center 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 7 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 1 Dec 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
7-day Point-prevalence Abstinence (time frame: Month 1). 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 NCT02721082, which also lists 3 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 1 Dec 2022.