This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00913770
First received: June 1, 2009
Last updated: August 4, 2016
Last verified: August 2016
Results First Received: May 11, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Opiate Addiction
Interventions: Behavioral: Brief Negotiation Interview (BNI)
Drug: Buprenorphine 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 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
  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.
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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
  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:  
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


Publications of Results:

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00913770     History of Changes
Other Study ID Numbers: 1R01DA025991-01 ( U.S. NIH Grant/Contract )
Study First Received: June 1, 2009
Results First Received: May 11, 2015
Last Updated: August 4, 2016