Tobacco Use DisorderPhase 3NCT02896400
Optimizing Tobacco Dependence Treatment in the Emergency Department
A Phase 3 study testing Brief Negotiated Interview (BNI), Nicotine replacement therapy (NRT) and CT Smokers Quitline (QL) in people with Tobacco Use Disorder, run by Yale University at 1 site in United States.
Trial summary
The investigators propose an innovative full-factorial design in a cohort of 1056 adult smokers in an urban emergency department (ED), to test the efficacy of four key intervention components: motivational interviewing, medication, quitline referral, and texting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Brief Negotiated Interview (BNI), Nicotine replacement therapy (NRT) and CT Smokers Quitline (QL)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,056 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2017to 14 Aug 2019
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- have smoked >= 100 cigarettes lifetime
- describe themselves as every or some day smokers
- smoke at least 5 cigarettes/day
- own a cellphone with texting capability
- are able to give written informed consent
Who cannot join
- Inability to read or understand English
- currently receiving formal tobacco dependence treatment
- life-threatening or unstable medical, surgical, or psychobehavioral condition
- unable to provide at least one collateral contact
- live out-of-state
- leaving the ED against medical advice
- pregnant (self-report or urine testing), nursing, or trying to conceive.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06519
About this study
The investigators propose an innovative full-factorial design in a cohort of 1056 adult smokers in an urban emergency department (ED), to test the efficacy of four key intervention components: motivational interviewing, medication, quitline referral, and texting. At the trial's completion, a mixed-methods approach will be used to identify the components that were efficacious within the proposed cost constraint, along with feasibility and acceptability to providers and subjects. The investigators will then assemble an intervention that maximizes efficacy, given a cost-effectiveness constraint and findings from a qualitative analysis.
Read the detailed description
The investigators propose to optimize the identification and treatment of adult smokers seen in a hospital ED. To do this the Multiple Optimization Strategy (MOST) will be employed to develop a multicomponent intervention that will consist of some combination of the following: (1) a Brief Negotiation Interview (BNI, a variant of a motivational interview), delivered by a trained research assistant; (2) provision of 6 weeks of nicotine patches and gum to the research participant, with application of the first patch in the ED (NRT); (3) active referral to the Connecticut Smokers' Quitline (QL); and (4) enrollment in the SmokefreeText a short-messaging service (SMS) texting program for mobile phones (Text). Using MOST principles, the first phase of the study will use a 2x2x2x2 full-factorial design to identify the components most likely to be efficacious in combination. Although the factorial design requires the allocation of participants to 16 different combinations of the 4 components (Table 1), evaluation of each individual component is performed comparing all of those receiving a component to all of those not receiving a component, making this an efficient design. For instance, evaluation of the BNI component will compare those randomized to arms 1 through 8 to those in arms 9 to 16.The second phase will consist of designing and proposing a 2-arm randomized clinical trial comparing the efficacy of the multicomponent intervention package to usual care; this will be conducted in a future application.
The specific aims of this proposed study are:
Aim 1. To conduct a fully powered factorial randomized trial of 1056 adult smokers to test the efficacy of 4 key components of ED-initiated tobacco treatment: Brief Negotiated Interview (BNI), nicotine replacement therapy (NRT), Quitline referral (QL), and SmokeFreeText (Text).
Aim 2. To identify the most efficacious components of our intervention, within fixed constraints of cost effectiveness and feasibility/acceptability to providers and subjects.
Aim 3. To lay the groundwork for a future randomized trial testing the previously identified components, delivered as a package, against a control arm in a new cohort of adult ED smokers.
Our associated hypotheses are:
- At 3 months, at least 1 intervention component will yield a biochemically verified tobacco abstinence rate at least 5% greater than in the control condition. Carbon monoxide breath test will be used for biochemical verification.
- At 3 months, at least 1 intervention will be cost-effective, using a societal perspective.
- At 3 months, at least 1 intervention will be acceptable and feasible to providers and subjects.
- Conditions
- Tobacco Use Disorder
- Being tested
- Brief Negotiated Interview (BNI), Nicotine replacement therapy (NRT), CT Smokers Quitline (QL), SmokefreeText (Text)
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Negotiated Interview (BNI)Behavioural
Brief motivational interview on smoking behavior
Nicotine replacement therapy (NRT)Drug
6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.
CT Smokers Quitline (QL)Other
Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
SmokefreeText (Text)Other
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
| Study group | Role | What they receive |
|---|---|---|
| BNI+NRT+QL+Text | Experimental | Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) Receives: Behavioral: Brief Negotiated Interview (BNI); Drug: Nicotine replacement therapy (NRT); Other: CT Smokers Quitline (QL); Other: SmokefreeText (Text) |
| BNI+NRT+QL | Experimental | Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Receives: Behavioral: Brief Negotiated Interview (BNI); Drug: Nicotine replacement therapy (NRT); Other: CT Smokers Quitline (QL) |
| BNI+NRT+Text | Experimental | Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text) Receives: Behavioral: Brief Negotiated Interview (BNI); Drug: Nicotine replacement therapy (NRT); Other: SmokefreeText (Text) |
| BNI+NRT | Experimental | Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Receives: Behavioral: Brief Negotiated Interview (BNI); Drug: Nicotine replacement therapy (NRT) |
| BNI+QL+Text | Experimental | Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) Receives: Behavioral: Brief Negotiated Interview (BNI); Other: CT Smokers Quitline (QL); Other: SmokefreeText (Text) |
| BNI+QL | Experimental | Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Receives: Behavioral: Brief Negotiated Interview (BNI); Other: CT Smokers Quitline (QL) |
| BNI+Text | Experimental | Brief Negotiated Interview (BNI) Registration in SmokefreeText (Text) Receives: Behavioral: Brief Negotiated Interview (BNI); Other: SmokefreeText (Text) |
| BNI only | Experimental | Brief Negotiated Interview (BNI) Receives: Behavioral: Brief Negotiated Interview (BNI) |
| NRT+QL+Text | Experimental | Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) Receives: Drug: Nicotine replacement therapy (NRT); Other: CT Smokers Quitline (QL); Other: SmokefreeText (Text) |
| NRT+QL | Experimental | Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Receives: Drug: Nicotine replacement therapy (NRT); Other: CT Smokers Quitline (QL) |
| NRT+Text | Experimental | Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text) Receives: Drug: Nicotine replacement therapy (NRT); Other: SmokefreeText (Text) |
| NRT only | Experimental | Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Receives: Drug: Nicotine replacement therapy (NRT) |
| QL+Text | Experimental | Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) Receives: Other: CT Smokers Quitline (QL); Other: SmokefreeText (Text) |
| QL only | Experimental | Referral to CT Smokers Quitline (QL) Receives: Other: CT Smokers Quitline (QL) |
| Text only | Experimental | Registration in SmokefreeText (Text) Receives: Other: SmokefreeText (Text) |
| Control | No intervention | Control arm, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tobacco Abstinence
Abstinence self reported and verified by exhaled carbon monoxide
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study start13 Feb 2017
- Primary completion14 Aug 2019
- Study completion14 Aug 2019
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 (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,056 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Steven L Bernstein, MD, Principal investigator, Yale School of Medicine, Department of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896400
- Sponsor's protocol ID
- 1603017332
- Other IDs
- 1R01CA201873-01A1
- Status last verified
- Nov 2020
- First submitted
- 6 Sep 2016
- Last updated
- 4 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bernstein SL, Dziura J, Weiss J, Miller T, Vickerman KA, Grau LE, Pantalon MV, Abroms L, Collins LM, Toll B. Tobacco dependence treatment in the emergency department: A randomized trial using the Multiphase Optimization Strategy. Contemp Clin Trials. 2018 Mar;66:1-8. doi: 10.1016/j.cct.2017.12.016. Epub 2017 Dec 27.
PubMed 29287665
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Tobacco Dependence Treatment in the Emergency Department
- ClinicalTrials.gov ID
- NCT02896400
- Acronym / sponsor ID
- 1603017332
- Conditions
- Tobacco Use Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,056 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 14 Aug 2019 (actual)
- Study completion
- 14 Aug 2019 (actual)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Posted 16 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose an innovative full-factorial design in a cohort of 1056 adult smokers in an urban emergency department (ED), to test the efficacy of four key intervention components: motivational interviewing, medication, quitline referral, and texting. At the trial's completion, a mixed-methods approach will be used to identify the components that were efficacious within the proposed cost constraint, along with feasibility and acceptability to providers and subjects. The investigators will then assemble an intervention that maximizes efficacy, given a cost-effectiveness constraint and findings from a qualitative analysis.
Detailed description
The investigators propose to optimize the identification and treatment of adult smokers seen in a hospital ED. To do this the Multiple Optimization Strategy (MOST) will be employed to develop a multicomponent intervention that will consist of some combination of the following: (1) a Brief Negotiation Interview (BNI, a variant of a motivational interview), delivered by a trained research assistant; (2) provision of 6 weeks of nicotine patches and gum to the research participant, with application of the first patch in the ED (NRT); (3) active referral to the Connecticut Smokers' Quitline (QL); and (4) enrollment in the SmokefreeText a short-messaging service (SMS) texting program for mobile phones (Text). Using MOST principles, the first phase of the study will use a 2x2x2x2 full-factorial design to identify the components most likely to be efficacious in combination. Although the factorial design requires the allocation of participants to 16 different combinations of the 4 components (Table 1), evaluation of each individual component is performed comparing all of those receiving a component to all of those not receiving a component, making this an efficient design. For instance, evaluation of the BNI component will compare those randomized to arms 1 through 8 to those in arms 9 to 16.The second phase will consist of designing and proposing a 2-arm randomized clinical trial comparing the efficacy of the multicomponent intervention package to usual care; this will be conducted in a future application.
The specific aims of this proposed study are:
Aim 1. To conduct a fully powered factorial randomized trial of 1056 adult smokers to test the efficacy of 4 key components of ED-initiated tobacco treatment: Brief Negotiated Interview (BNI), nicotine replacement therapy (NRT), Quitline referral (QL), and SmokeFreeText (Text).
Aim 2. To identify the most efficacious components of our intervention, within fixed constraints of cost effectiveness and feasibility/acceptability to providers and subjects.
Aim 3. To lay the groundwork for a future randomized trial testing the previously identified components, delivered as a package, against a control arm in a new cohort of adult ED smokers.
Our associated hypotheses are:
- At 3 months, at least 1 intervention component will yield a biochemically verified tobacco abstinence rate at least 5% greater than in the control condition. Carbon monoxide breath test will be used for biochemical verification.
- At 3 months, at least 1 intervention will be cost-effective, using a societal perspective.
- At 3 months, at least 1 intervention will be acceptable and feasible to providers and subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| BNI+NRT+QL+Text | Experimental | Behavioral: Brief Negotiated Interview (BNI), Drug: Nicotine replacement therapy (NRT), Other: CT Smokers Quitline (QL), Other: SmokefreeText (Text)Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) |
| BNI+NRT+QL | Experimental | Behavioral: Brief Negotiated Interview (BNI), Drug: Nicotine replacement therapy (NRT), Other: CT Smokers Quitline (QL)Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) |
| BNI+NRT+Text | Experimental | Behavioral: Brief Negotiated Interview (BNI), Drug: Nicotine replacement therapy (NRT), Other: SmokefreeText (Text)Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text) |
| BNI+NRT | Experimental | Behavioral: Brief Negotiated Interview (BNI), Drug: Nicotine replacement therapy (NRT)Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply |
| BNI+QL+Text | Experimental | Behavioral: Brief Negotiated Interview (BNI), Other: CT Smokers Quitline (QL), Other: SmokefreeText (Text)Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) |
| BNI+QL | Experimental | Behavioral: Brief Negotiated Interview (BNI), Other: CT Smokers Quitline (QL)Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) |
| BNI+Text | Experimental | Behavioral: Brief Negotiated Interview (BNI), Other: SmokefreeText (Text)Brief Negotiated Interview (BNI) Registration in SmokefreeText (Text) |
| BNI only | Experimental | Behavioral: Brief Negotiated Interview (BNI)Brief Negotiated Interview (BNI) |
| NRT+QL+Text | Experimental | Drug: Nicotine replacement therapy (NRT), Other: CT Smokers Quitline (QL), Other: SmokefreeText (Text)Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) |
| NRT+QL | Experimental | Drug: Nicotine replacement therapy (NRT), Other: CT Smokers Quitline (QL)Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) |
| NRT+Text | Experimental | Drug: Nicotine replacement therapy (NRT), Other: SmokefreeText (Text)Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text) |
| NRT only | Experimental | Drug: Nicotine replacement therapy (NRT)Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply |
| QL+Text | Experimental | Other: CT Smokers Quitline (QL), Other: SmokefreeText (Text)Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) |
| QL only | Experimental | Other: CT Smokers Quitline (QL)Referral to CT Smokers Quitline (QL) |
| Text only | Experimental | Other: SmokefreeText (Text)Registration in SmokefreeText (Text) |
| Control | No intervention | –Control arm, no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older
- have smoked >= 100 cigarettes lifetime
- describe themselves as every or some day smokers
- smoke at least 5 cigarettes/day
- own a cellphone with texting capability
Key exclusion criteria (7 listed)
- Inability to read or understand English
- currently receiving formal tobacco dependence treatment
- life-threatening or unstable medical, surgical, or psychobehavioral condition
- unable to provide at least one collateral contact
- live out-of-state
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 Negotiated Interview (BNI)Brief motivational interview on smoking behavior | Behavioural | BNI only, BNI+NRT, BNI+NRT+QL, BNI+NRT+QL+Text, BNI+NRT+Text, BNI+QL, BNI+QL+Text, BNI+Text |
| Nicotine replacement therapy (NRT)6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece. | Drug | BNI+NRT, BNI+NRT+QL, BNI+NRT+QL+Text, BNI+NRT+Text, NRT only, NRT+QL, NRT+QL+Text, NRT+Text |
| CT Smokers Quitline (QL)Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling. | Other | BNI+NRT+QL, BNI+NRT+QL+Text, BNI+QL, BNI+QL+Text, NRT+QL, NRT+QL+Text, QL only, QL+Text |
| SmokefreeText (Text)Enrollment in a version of NCI's SmokefreeTxt, tailored for the study. | Other | BNI+NRT+QL+Text, BNI+NRT+Text, BNI+QL+Text, BNI+Text, NRT+QL+Text, NRT+Text, QL+Text, Text only |
Primary outcome
Tobacco Abstinence
Time frame: 3 months
Abstinence self reported and verified by exhaled carbon monoxide
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29287665Bernstein SL, Dziura J, Weiss J, Miller T, Vickerman KA, Grau LE, Pantalon MV, Abroms L, Collins LM, Toll B. Tobacco dependence treatment in the emergency department: A randomized trial using the Multiphase Optimization Strategy. Contemp Clin Trials. 2018 Mar;66:1-8. doi: 10.1016/j.cct.2017.12.016. Epub 2017 Dec 27.
- Individual participant dataSharing planned: No
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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 L Bernstein, MD principal investigator
Yale School of Medicine, Department of Emergency Medicine
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 Negotiated Interview (BNI), Nicotine replacement therapy (NRT) and CT Smokers Quitline (QL) in people with Tobacco Use Disorder, run by Yale University 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 Dec 2020. 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?
Yes. Results are posted in the registry (first posted 16 Nov 2020). 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?
Tobacco Abstinence (time frame: 3 months). 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 NCT02896400, which also lists 1 linked publication.
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 Dec 2020.