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

March 12, 2020 updated by: Yale University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

329

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University
      • New Haven, Connecticut, United States, 06519
        • Yale University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported Engagement in Formal Substance Abuse Treatment at 30 Days (Verified by Contact With the Treatment Program)
Time Frame: 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.
30 days post randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Days of Self-reported Illicit Opioid Use in the Past 7 Days
Time Frame: 30 days post randomization
30 days post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

June 1, 2009

First Submitted That Met QC Criteria

June 3, 2009

First Posted (Estimate)

June 4, 2009

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 12, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0808004132
  • 1R01DA025991-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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