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Optimizing Tobacco Dependence Treatment in the Emergency Department

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ClinicalTrials.gov Identifier: NCT02896400
Recruitment Status : Recruiting
First Posted : September 12, 2016
Last Update Posted : February 23, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Behavioral: Brief Negotiated Interview (BNI) Drug: Nicotine replacement therapy (NRT) Other: CT Smokers Quitline (QL) Other: SmokefreeText (Text) Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1056 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Optimizing Tobacco Dependence Treatment in the Emergency Department
Actual Study Start Date : February 13, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
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

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

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

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: 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+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

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

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

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+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

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: 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)
Behavioral: Brief Negotiated Interview (BNI)
Brief motivational interview on smoking behavior

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

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

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

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.

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

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.

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+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.

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

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: 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.

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

No Intervention: Control
Control arm, no intervention



Primary Outcome Measures :
  1. Tobacco abstinence [ Time Frame: 3 months ]
    Abstinence self reported and verified by exhaled carbon monoxide



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02896400


Contacts
Contact: June-Marie Weiss, MA, MEd 203-737-3582 junemarie.weiss@yale.edu

Locations
United States, Connecticut
Yale School of Medicine Recruiting
New Haven, Connecticut, United States, 06519
Contact: June-Marie Weiss, MA, MEd    203-737-3582    junemarie.weiss@yale.edu   
Sponsors and Collaborators
Yale University
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Investigators
Principal Investigator: Steven L Bernstein, MD Yale School of Medicine, Department of Emergency Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02896400     History of Changes
Other Study ID Numbers: 1603017332
1R01CA201873-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Tobacco Use Disorder
Emergencies
Disease Attributes
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action