Optimizing Tobacco Dependence Treatment in the Emergency Department

ID: NCT02896400
Status: Recruiting
Phase: Phase 3
Start Date: February 13, 2017
First Submitted: September 06, 2016
Last Updated: February 21, 2018
Results: N/A
Organization: Yale University
Sponsors & Collaborators: Yale University, National Cancer Institute (NCI), National Institutes of Health (NIH)
Location: United States
Conditions: Tobacco Use Disorder
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Study Description

Brief 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. 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; (3) active referral to the Connecticut Smokers' Quitline; and (4) enrollment in the SmokefreeTXT short-messaging service (SMS) texting program for mobile phones. 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: BNI, NRT, QL referral, and SMS texting.

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:

1. 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.

2. At 3 months, at least 1 intervention will be cost-effective, using a societal perspective.

3. At 3 months, at least 1 intervention will be acceptable and feasible to providers and subjects.
Condition or disease Intervention/treatment Phase

Tobacco Use Disorder

Behavioral: Brief Negotiated Interview (BNI)
Other Names
Drug: Nicotine replacement therapy (NRT)
Other Names
Other: CT Smokers Quitline (QL)
Other Names
Other: SmokefreeText (Text)
Other Names
Phase 3

Tracking Information

First Submitted DateSeptember 06, 2016
Last Update Posted DateFebruary 21, 2018
Actual Start DateFebruary 13, 2017
Anticipated Completion DateJune 01, 2020
Actual Primary Completion DateApril 01, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Tobacco abstinence [Time Frame: 3 months]

    Abstinence self reported and verified by exhaled carbon monoxide

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleOptimizing Tobacco Dependence Treatment in the Emergency Department
Official TitleOptimizing Tobacco Dependence Treatment in the Emergency Department
Brief 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. 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; (3) active referral to the Connecticut Smokers' Quitline; and (4) enrollment in the SmokefreeTXT short-messaging service (SMS) texting program for mobile phones. 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: BNI, NRT, QL referral, and SMS texting.

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:

1. 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.

2. At 3 months, at least 1 intervention will be cost-effective, using a societal perspective.

3. At 3 months, at least 1 intervention will be acceptable and feasible to providers and subjects.

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
1056
Allocation
Randomized
Interventional Model
Factorial Assignment
Masking
Single
Primary Purpose
Treatment
Conditions
Tobacco Use Disorder
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Behavioral: Brief Negotiated Interview (BNI)

Brief motivational interview on smoking behavior

Other Names
Drug: 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.

Other Names
Other: 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 Names
Other: SmokefreeText (Text)

Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.

Other Names
Study Groups/Cohorts
BNI+NRT+QL+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
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)

BNI+NRT+Text
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)

BNI+NRT
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply

BNI+QL+Text
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)

BNI+QL
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL)

BNI+Text
Brief Negotiated Interview (BNI) Registration in SmokefreeText (Text)

BNI only
Brief Negotiated Interview (BNI)

NRT+QL+Text
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)

NRT+QL
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)

NRT+Text
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)

NRT only
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply

QL+Text
Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)

QL only
Referral to CT Smokers Quitline (QL)

Text only
Registration in SmokefreeText (Text)

Control
Control arm, no intervention

Study Arms
Experimental BNI only
Brief Negotiated Interview (BNI)
Behavioral : Brief Negotiated Interview (BNI)
Brief motivational interview on smoking behavior

Experimental BNI+NRT
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply
Behavioral : Brief Negotiated Interview (BNI)
Brief motivational interview on smoking behavior

Experimental BNI+NRT
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply
Drug : 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.

Experimental BNI+NRT+QL
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
Drug : 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.

Experimental BNI+NRT+QL
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
Behavioral : Brief Negotiated Interview (BNI)
Brief motivational interview on smoking behavior

Experimental BNI+NRT+QL
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
Other : CT Smokers Quitline (QL)
Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.

Experimental BNI+NRT+QL+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)
Other : CT Smokers Quitline (QL)
Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.

Experimental BNI+NRT+QL+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)
Other : SmokefreeText (Text)
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.

Experimental BNI+NRT+QL+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)
Drug : 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.

Experimental BNI+NRT+QL+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)
Behavioral : Brief Negotiated Interview (BNI)
Brief motivational interview on smoking behavior

Experimental BNI+NRT+Text
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
Drug : 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.

Experimental BNI+NRT+Text
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
Behavioral : Brief Negotiated Interview (BNI)
Brief motivational interview on smoking behavior

Experimental BNI+NRT+Text
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
Other : SmokefreeText (Text)
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.

Experimental BNI+QL
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL)
Other : CT Smokers Quitline (QL)
Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.

Experimental BNI+QL
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL)
Behavioral : Brief Negotiated Interview (BNI)
Brief motivational interview on smoking behavior

Experimental BNI+QL+Text
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
Behavioral : Brief Negotiated Interview (BNI)
Brief motivational interview on smoking behavior

Experimental BNI+QL+Text
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
Other : CT Smokers Quitline (QL)
Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.

Experimental BNI+QL+Text
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
Other : SmokefreeText (Text)
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.

Experimental BNI+Text
Brief Negotiated Interview (BNI) Registration in SmokefreeText (Text)
Other : SmokefreeText (Text)
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.

Experimental BNI+Text
Brief Negotiated Interview (BNI) Registration in SmokefreeText (Text)
Behavioral : Brief Negotiated Interview (BNI)
Brief motivational interview on smoking behavior

Experimental NRT only
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply
Drug : 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.

Experimental NRT+QL
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
Drug : 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.

Experimental NRT+QL
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
Other : CT Smokers Quitline (QL)
Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.

Experimental NRT+QL+Text
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
Other : CT Smokers Quitline (QL)
Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.

Experimental NRT+QL+Text
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
Other : SmokefreeText (Text)
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.

Experimental NRT+QL+Text
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
Drug : 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.

Experimental NRT+Text
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
Drug : 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.

Experimental NRT+Text
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
Other : SmokefreeText (Text)
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.

Experimental QL only
Referral to CT Smokers Quitline (QL)
Other : CT Smokers Quitline (QL)
Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.

Experimental QL+Text
Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
Other : CT Smokers Quitline (QL)
Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.

Experimental QL+Text
Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
Other : SmokefreeText (Text)
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.

Experimental Text only
Registration in SmokefreeText (Text)
Other : SmokefreeText (Text)
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.

Arm Intervention/Treatment
Experimental BNI only
Brief Negotiated Interview (BNI)
Behavioral : Brief Negotiated Interview (BNI)
Experimental BNI+NRT
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply
Behavioral : Brief Negotiated Interview (BNI)
Experimental BNI+NRT
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply
Drug : Nicotine replacement therapy (NRT)
Experimental BNI+NRT+QL
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
Drug : Nicotine replacement therapy (NRT)
Experimental BNI+NRT+QL
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
Behavioral : Brief Negotiated Interview (BNI)
Experimental BNI+NRT+QL
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
Other : CT Smokers Quitline (QL)
Experimental BNI+NRT+QL+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)
Other : CT Smokers Quitline (QL)
Experimental BNI+NRT+QL+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)
Other : SmokefreeText (Text)
Experimental BNI+NRT+QL+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)
Drug : Nicotine replacement therapy (NRT)
Experimental BNI+NRT+QL+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)
Behavioral : Brief Negotiated Interview (BNI)
Experimental BNI+NRT+Text
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
Drug : Nicotine replacement therapy (NRT)
Experimental BNI+NRT+Text
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
Behavioral : Brief Negotiated Interview (BNI)
Experimental BNI+NRT+Text
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
Other : SmokefreeText (Text)
Experimental BNI+QL
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL)
Other : CT Smokers Quitline (QL)
Experimental BNI+QL
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL)
Behavioral : Brief Negotiated Interview (BNI)
Experimental BNI+QL+Text
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
Behavioral : Brief Negotiated Interview (BNI)
Experimental BNI+QL+Text
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
Other : CT Smokers Quitline (QL)
Experimental BNI+QL+Text
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
Other : SmokefreeText (Text)
Experimental BNI+Text
Brief Negotiated Interview (BNI) Registration in SmokefreeText (Text)
Other : SmokefreeText (Text)
Experimental BNI+Text
Brief Negotiated Interview (BNI) Registration in SmokefreeText (Text)
Behavioral : Brief Negotiated Interview (BNI)
Experimental NRT only
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply
Drug : Nicotine replacement therapy (NRT)
Experimental NRT+QL
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
Drug : Nicotine replacement therapy (NRT)
Experimental NRT+QL
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
Other : CT Smokers Quitline (QL)
Experimental NRT+QL+Text
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
Other : CT Smokers Quitline (QL)
Experimental NRT+QL+Text
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
Other : SmokefreeText (Text)
Experimental NRT+QL+Text
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
Drug : Nicotine replacement therapy (NRT)
Experimental NRT+Text
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
Drug : Nicotine replacement therapy (NRT)
Experimental NRT+Text
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
Other : SmokefreeText (Text)
Experimental QL only
Referral to CT Smokers Quitline (QL)
Other : CT Smokers Quitline (QL)
Experimental QL+Text
Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
Other : CT Smokers Quitline (QL)
Experimental QL+Text
Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
Other : SmokefreeText (Text)
Experimental Text only
Registration in SmokefreeText (Text)
Other : SmokefreeText (Text)

Recruitment Information

Recruitment Status:Recruiting
Enrollment1056
Completion DateJune 01, 2020
Eligibility Criteria: Inclusion Criteria:
- 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

Exclusion Criteria:
- 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.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT02896400
Other Study ID Numbers
1603017332
1R01CA201873-01A1
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Yale University
Collaborators
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Investigators
Principal Investigator
Steven L Bernstein, MD
Yale School of Medicine, Department of Emergency Medicine