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

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00913770
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 329
• Locations: 2
• Arms: 3
• Duration (Months): 75
• Patients Per Site: 164.5
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

Patients with heroin and prescription opioid dependence are at increased risk for adverse health consequences and often utilize the Emergency Department (ED) as their source of medical care. Screening, brief intervention and referral to treatment has been effective in decreasing high risk behaviors such as alcohol and tobacco use, and unsafe sexual practices. The data on the effectiveness of brief interventions with opioid dependence is limited. This prospective, randomized controlled trial of opioid dependent subjects (N=360) will compare two models of brief intervention with a control condition. ED patients with opioid dependence will be randomized to either: (1)Screening, Brief Intervention with a Facilitated Referral to Treatment (SBIRT); (2) Screening, Brief Intervention with ED initiated Buprenorphine Treatment (SBI+Bup); or (3) standard care (SC) which includes a handout detailing substance abuse treatment centers in the area. The primary outcome will be self-reported engagement in formal substance abuse treatment at 30 days, verified by contact with the treatment program. Other outcomes measured at 30 days, 2, 6 and 12 months include changes in opioid use (self-report and urine toxicology analysis), HIV risk behaviors, and health care service utilization. The three interventions will also be compared on their cost-effectiveness. We will test the hypotheses that SBI+Bup will be superior to SBIRT and SC, and SBIRT will be superior to SC in (1)increasing the proportion of patients engaged in formal substance abuse treatment at 30 days; (2) reducing illicit opioid use; (3) reducing HIV risk behaviors; and (4) reducing health care service utilization. In addition, we hypothesize that the societal costs of SBI+Bup, per number of days of opioid abstinence, will be cost effective relative to SBIRT or SC; and that SBIRT will be cost effective relative to SC. Data analyses will be conducted on the intention to treat sample of randomized patients. This study, conducted by a research team with extensive experience evaluating brief interventions and treatments for opioid dependence, will be unique in its: (1) comparison of two models of brief intervention with standard care; (2) inclusion of an ED initiated treatment arm; (3) use of manual-guided interventions with systematic assessment of adherence and competence; and (4)collection of detailed cost data to help guide future healthcare policy.

Condition or Disease	Intervention/Treatment	Phase
Opiate Addiction	Behavioral: Brief Negotiation Interview (BNI); Drug: Buprenorphine Initiation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 329 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Models of Screening, Brief Intervention With a Facilitated Referral to Treatment (SBIRT) for Opioid Patients in the Emergency Department
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: SC Standard Care
Experimental: SBIRT Screening, Brief Intervention and Facilitated Referral to Treatment	Behavioral: Brief Negotiation Interview (BNI); Brief Negotiation Interview (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.
Experimental: SBI+Bup Screening, Brief Intervention and Buprenorphine initiation	Behavioral: Brief Negotiation Interview (BNI); Brief Negotiation Interview (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.; Drug: Buprenorphine Initiation

Outcome Measures

Primary Outcome Measures

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

   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.

Secondary Outcome Measures

1. Days of Self-reported Illicit Opioid Use in the Past 7 Days [30 days post randomization]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients who present to the adult ED at Yale-New Haven Hospital (YNHH) who are:

1. 18 years or older,

2. meet criteria for opioid dependence as measured by the Mini-SCID, and

3. have a positive urine toxicology for opiates.

Exclusion Criteria:

• Inability to read or understand English

• Currently receiving formal substance abuse treatment

• Current suicide or homicidal risk

• Current psychotic disorder

• Life-threatening or unstable medical or psychiatric condition requiring hospital admission

• Unable to provide 2 phone contact numbers

• Unwilling to be randomized and/or follow up as per study protocol, including release of information to assess treatment engagement at 30-days

• Requiring opioid agonist medication for a pain-related diagnosis (contraindication to buprenorphine)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale University	New Haven	Connecticut	United States	06510
2	Yale University School of Medicine	New Haven	Connecticut	United States	06519

Sponsors and Collaborators

• Yale University
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Gail D'Onofrio, MD, MS, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT00913770
• Other Study ID Numbers: 0808004132; 1R01DA025991-01
• First Posted: Jun 4, 2009
• Last Update Posted: Mar 24, 2020
• Last Verified: Mar 1, 2020

• Keywords provided by Yale University: opioid dependence; buprenorphine; brief intervention
• Additional relevant MeSH terms: Emergencies; Opioid-Related Disorders; Buprenorphine

Study Results

Participant Flow

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

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 Participants	104	111	114	329
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.4 (10.6)	31.9 (9.7)	31 (9.8)	31.4 (10.6)
Sex: Female, Male (Count of 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.
Measure Participants	102	111	114
Mean (95% Confidence Interval) [Mean Number of Outpatient Visits]	4.99	5.67	3.71

2. Secondary Outcome

Title	Days of Self-reported Illicit Opioid Use in the Past 7 Days
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.
Measure Participants	102	111	114
Mean (95% Confidence Interval) [Mean Number of Days]	2.3	2.4	0.9

Adverse Events

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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard Care		SBIRT		SBI+Bup
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/104 (0%)		0/111 (0%)		0/114 (0%)
Other (Not Including Serious) Adverse Events
	Standard Care		SBIRT		SBI+Bup
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/104 (0%)		0/111 (0%)		0/114 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.