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Treating Low-Income Smokers in the Hospital Emergency Department

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Steven Bernstein, Yale University
ClinicalTrials.gov Identifier:
NCT01328431
First received: March 30, 2011
Last updated: July 8, 2014
Last verified: July 2014
Results First Received: July 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Tobacco Use Cessation
Smoking Cessation
Smoking
Tobacco Use Disorder
Intervention: Other: Brief Intervention with NRT Initiation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Standard Care Subjects receive a brochure for the state's Smokers' Quitline only.
SBIRT+NRT

Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.

Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor.


Participant Flow for 4 periods

Period 1:   Baseline
    Standard Care     SBIRT+NRT  
STARTED     390     390  
COMPLETED     390     388 [1]
NOT COMPLETED     0     2  
Protocol Violation                 0                 2  
[1] Two subjects enrolled in study twice. Protocol violation.

Period 2:   1 Month (1M)
    Standard Care     SBIRT+NRT  
STARTED     390     388  
COMPLETED     335     330  
NOT COMPLETED     55     58  
Lost to Follow-up                 55                 58  

Period 3:   3 Month (3M)
    Standard Care     SBIRT+NRT  
STARTED     390 [1]   388 [1]
COMPLETED     313     316  
NOT COMPLETED     77     72  
Death                 2                 2  
Lost to Follow-up                 75                 70  
[1] Attempted to contact all subjects for 3M follow-up, regardless of whether they completed 1M.

Period 4:   12 Month (12M)
    Standard Care     SBIRT+NRT  
STARTED     388 [1]   386 [1]
COMPLETED     304     289  
NOT COMPLETED     84     97  
Death                 2                 6  
Lost to Follow-up                 82                 91  
[1] Attempted to contact all subjects at 12M follow-up. Deceased subjects excluded.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Standard Care Subjects receive a brochure for the state's Smokers' Quitline only.
SBIRT+NRT

Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.

Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor.

Total Total of all reporting groups

Baseline Measures
    Standard Care     SBIRT+NRT     Total  
Number of Participants  
[units: participants]
  390     388     778  
Age  
[units: participants]
     
<=18 years     4     2     6  
Between 18 and 65 years     384     376     760  
>=65 years     2     10     12  
Gender  
[units: participants]
     
Female     189     218     407  
Male     201     170     371  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Biochemical Verification of Tobacco Abstinence   [ Time Frame: 3 months after enrollment ]

2.  Primary:   Self-report of Tobacco Abstinence or Reduction   [ Time Frame: 3 months ]

3.  Secondary:   Self-reported Tobacco Reduction or Abstinence   [ Time Frame: 1 month post enrollment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Health Care Service Utilization   [ Time Frame: 1 month post enrollment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Self-reported Tobacco Reduction or Abstinence   [ Time Frame: 12 months post enrollment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Health Care Service Utilization   [ Time Frame: 3 months post enrollment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Health Care Service Utilization   [ Time Frame: 12 months post enrollment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Steven L. Bernstein, MD
Organization: Yale University
phone: 203-737-3574
e-mail: steven.bernstein@yale.edu


No publications provided


Responsible Party: Steven Bernstein, Yale University
ClinicalTrials.gov Identifier: NCT01328431     History of Changes
Other Study ID Numbers: 0907005437, R01CA141479
Study First Received: March 30, 2011
Results First Received: July 8, 2014
Last Updated: July 8, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government