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

Primary Purpose

Opiate Addiction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Negotiation Interview (BNI)
Buprenorphine Initiation
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opiate Addiction focused on measuring opioid dependence, buprenorphine, brief intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Yale University
  • Yale University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

SC

SBIRT

SBI+Bup

Arm Description

Standard Care

Screening, Brief Intervention and Facilitated Referral to Treatment

Screening, Brief Intervention and Buprenorphine initiation

Outcomes

Primary Outcome Measures

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

Days of Self-reported Illicit Opioid Use in the Past 7 Days

Full Information

First Posted
June 1, 2009
Last Updated
March 12, 2020
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00913770
Brief Title
Models of Screening, Brief Intervention With a Facilitated Referral to Treatment (SBIRT) for Opioid Patients in the Emergency Department
Official Title
Models of Screening, Brief Intervention With a Facilitated Referral to Treatment (SBIRT) for Opioid Patients in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Addiction
Keywords
opioid dependence, buprenorphine, brief intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
329 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SC
Arm Type
No Intervention
Arm Description
Standard Care
Arm Title
SBIRT
Arm Type
Experimental
Arm Description
Screening, Brief Intervention and Facilitated Referral to Treatment
Arm Title
SBI+Bup
Arm Type
Experimental
Arm Description
Screening, Brief Intervention and Buprenorphine initiation
Intervention Type
Behavioral
Intervention Name(s)
Brief Negotiation Interview (BNI)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Buprenorphine Initiation
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
Title
Days of Self-reported Illicit Opioid Use in the Past 7 Days
Time Frame
30 days post randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who present to the adult ED at Yale-New Haven Hospital (YNHH) who are: 18 years or older, meet criteria for opioid dependence as measured by the Mini-SCID, and 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail D'Onofrio, MD, MS
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25919527
Citation
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.
Results Reference
result
PubMed Identifier
28815789
Citation
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.
Results Reference
result
PubMed Identifier
28194688
Citation
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.
Results Reference
result
PubMed Identifier
36063082
Citation
Nielsen S, Tse WC, Larance B. Opioid agonist treatment for people who are dependent on pharmaceutical opioids. Cochrane Database Syst Rev. 2022 Sep 5;9(9):CD011117. doi: 10.1002/14651858.CD011117.pub3.
Results Reference
derived

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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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