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

• 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: Yale University
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Standard Care	SBIRT	SBI+Bup
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

Baseline Characteristics

Arm/Group Title		Standard Care	SBIRT	SBI+Bup	Total
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
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%

Outcome Measures

1. Primary Outcome

Title	Self-reported Engagement in Formal Substance Abuse Treatment at 30 Days (Verified by Contact With the Treatment Program)
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

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	30 days post randomization

Outcome Measure Data

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
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)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Standard Care	SBIRT	SBI+Bup
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	--/--	--/--	--/--
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%)
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%)

Limitations and Caveats

[Not Specified]

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
• EMail: gail.donofrio@yale.edu

Publications of Results:

D'Onofrio G, O'Connor PG, Pantalon MV, Chawarski MC, Busch SH, Owens PH, Bernstein SL, Fiellin DA. Emergency department-initiated buprenorphine/naloxone treatment for opioid dependence: a randomized clinical trial. JAMA. 2015 Apr 28;313(16):1636-44. doi: 10.1001/jama.2015.3474.

Busch SH, Fiellin DA, Chawarski MC, Owens PH, Pantalon MV, Hawk K, Bernstein SL, O'Connor PG, D'Onofrio G. Cost-effectiveness of emergency department-initiated treatment for opioid dependence. Addiction. 2017 Nov;112(11):2002-2010. doi: 10.1111/add.13900. Epub 2017 Aug 16.

D'Onofrio G, Chawarski MC, O'Connor PG, Pantalon MV, Busch SH, Owens PH, Hawk K, Bernstein SL, Fiellin DA. Emergency Department-Initiated Buprenorphine for Opioid Dependence with Continuation in Primary Care: Outcomes During and After Intervention. J Gen Intern Med. 2017 Jun;32(6):660-666. doi: 10.1007/s11606-017-3993-2. Epub 2017 Feb 13.

• 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