Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Treating Low-Income Smokers in the Hospital Emergency Department

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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
  Hide Limitations and Caveats

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
  Hide More Information

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



Responsible Party: Steven Bernstein, Yale University
ClinicalTrials.gov Identifier: NCT01328431     History of Changes
Other Study ID Numbers: 0907005437
R01CA141479 ( US NIH Grant/Contract Award Number )
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