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

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ClinicalTrials.gov Identifier: NCT00913770
Recruitment Status : Completed
First Posted : June 4, 2009
Results First Posted : May 28, 2015
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Opiate Addiction
Interventions Behavioral: Brief Negotiation Interview (BNI)
Drug: Buprenorphine Initiation
Enrollment 329
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Care SBIRT SBI+Bup
Hide Arm/Group Description Standard Care including receiving a referral.

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.

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.

Period Title: Overall Study
Started 104 111 114
Completed 69 82 93
Not Completed 35 29 21
Reason Not Completed
Unable to contact             24             19             13
Refused             11             10             8
Arm/Group Title Standard Care SBIRT SBI+Bup Total
Hide Arm/Group Description Standard Care including receiving a referral.

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.

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 of all reporting groups
Overall Number of Baseline Participants 104 111 114 329
Hide Baseline Analysis Population Description
Baseline population description is the number of subjects randomized to study arm
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 104 participants 111 participants 114 participants 329 participants
31.4  (10.6) 31.9  (9.7) 31  (9.8) 31.4  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 111 participants 114 participants 329 participants
Female
23
  22.1%
27
  24.3%
28
  24.6%
78
  23.7%
Male
81
  77.9%
84
  75.7%
86
  75.4%
251
  76.3%
1.Primary Outcome
Title Self-reported Engagement in Formal Substance Abuse Treatment at 30 Days (Verified by Contact With the Treatment Program)
Hide Description Defined as enrollment and receiving formal addiction treatment on the 30th day following randomization. This is assessed by direct contact with facility, clinician, or both.
Time Frame 30 days post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were randomized to receive treatment were included in the primary analysis. 2 subjects were lost to follow up in the standard of care arm which is why 102 are included in the analysis instead of 104
Arm/Group Title Standard Care SBIRT SBI+Bup
Hide Arm/Group Description:
Standard Care including receiving a referral.

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.

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.

Overall Number of Participants Analyzed 102 111 114
Mean (95% Confidence Interval)
Unit of Measure: Mean Number of Outpatient Visits
4.99
(3.1 to 6.8)
5.67
(4.0 to 7.4)
3.71
(2.1 to 5.3)
2.Secondary Outcome
Title Days of Self-reported Illicit Opioid Use in the Past 7 Days
Hide Description [Not Specified]
Time Frame 30 days post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were randomized to receive treatment were included in the primary analysis. 2 subjects were lost to follow up in the standard of care arm which is why 102 are included in the analysis instead of 104
Arm/Group Title Standard Care SBIRT SBI+Bup
Hide Arm/Group Description:
Standard Care including receiving a referral.

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.

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.

Overall Number of Participants Analyzed 102 111 114
Mean (95% Confidence Interval)
Unit of Measure: Mean Number of Days
2.3
(1.7 to 3.0)
2.4
(1.8 to 3.0)
0.9
(0.5 to 1.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Care SBIRT SBI+Bup
Hide Arm/Group Description Standard Care including receiving a referral.

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.

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.

All-Cause Mortality
Standard Care SBIRT SBI+Bup
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Standard Care SBIRT SBI+Bup
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/104 (0.00%)   0/111 (0.00%)   0/114 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Standard Care SBIRT SBI+Bup
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/104 (0.00%)   0/111 (0.00%)   0/114 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gail D'Onofrio, MD, MS
Organization: Yale University
Phone: 203-785-4404
EMail: gail.donofrio@yale.edu
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00913770    
Other Study ID Numbers: 0808004132
1R01DA025991-01 ( U.S. NIH Grant/Contract )
First Submitted: June 1, 2009
First Posted: June 4, 2009
Results First Submitted: May 11, 2015
Results First Posted: May 28, 2015
Last Update Posted: March 24, 2020