Models of Screening, Brief Intervention With a Facilitated Referral to Treatment (SBIRT) for Opioid Patients in the Emergency Department

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00913770
First received: June 1, 2009
Last updated: May 11, 2015
Last verified: May 2015
Results First Received: May 11, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Opiate Addiction
Interventions: Other: Brief Intervention with Buprenorphine initiation
Behavioral: Brief Intervention

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Standard Care Standard Care including receiving a referral.
SBIRT

Screening, Brief Intervention and Facilitated Referral to Treatment

Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program.

SBI+Bup

Screening, Brief Intervention and Buprenorphine initiation

Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly.


Participant Flow:   Overall Study
    Standard Care     SBIRT     SBI+Bup  
STARTED     104     111     114  
COMPLETED     69     82     93  
NOT COMPLETED     35     29     21  
Unable to contact                 24                 19                 13  
Refused                 11                 10                 8  



  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.
Baseline population description is the number of subjects randomized to study arm

Reporting Groups
  Description
Standard Care Standard Care including receiving a referral.
SBIRT

Screening, Brief Intervention and Facilitated Referral to Treatment

Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program.

SBI+Bup

Screening, Brief Intervention and Buprenorphine initiation

Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly.

Total Total of all reporting groups

Baseline Measures
    Standard Care     SBIRT     SBI+Bup     Total  
Number of Participants  
[units: participants]
  104     111     114     329  
Age  
[units: years]
Mean (Standard Deviation)
  31.4  (10.6)     31.9  (9.7)     31  (9.8)     31.4  (10.6)  
Gender  
[units: participants]
       
Female     23     27     28     78  
Male     81     84     86     251  



  Outcome Measures
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1.  Primary:   Self-reported Engagement in Formal Substance Abuse Treatment at 30 Days (Verified by Contact With the Treatment Program)   [ Time Frame: 30 days post randomization ]

2.  Secondary:   Days of Self-reported Illicit Opioid Use in the Past 7 Days   [ Time Frame: 30 days post randomization ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Gail D'Onofrio, MD, MS
Organization: Yale University
phone: 203-785-4404
e-mail: gail.donofrio@yale.edu


No publications provided by Yale University

Publications automatically indexed to this study:

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00913770     History of Changes
Other Study ID Numbers: 1R01DA025991-01, 1R01DA025991-01
Study First Received: June 1, 2009
Results First Received: May 11, 2015
Last Updated: May 11, 2015
Health Authority: United States: Institutional Review Board