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

NCT00913770 | Completed Results

• 2 other identifiers: 08080041321R01DA025991-01
• Study Type: interventional
• Target: 329
• Locations: 1 country
• Sites: 2

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.

Conditions

Opiate Addiction

Keywords

opioid dependence; buprenorphine; brief intervention

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days post randomization

Secondary Outcomes (1)

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

  30 days post randomization

Study Arms (3)

SC

NO INTERVENTION

Standard Care

SBIRT

EXPERIMENTAL

Screening, Brief Intervention and Facilitated Referral to Treatment

Behavioral: Brief Negotiation Interview (BNI)

SBI+Bup

EXPERIMENTAL

Screening, Brief Intervention and Buprenorphine initiation

Behavioral: Brief Negotiation Interview (BNI); Drug: Buprenorphine Initiation

Interventions

Brief Negotiation Interview (BNI) BEHAVIORAL

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.

SBI+Bup; SBIRT

Buprenorphine Initiation DRUG

SBI+Bup

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who present to the adult ED at Yale-New Haven Hospital (YNHH) who are:
• years or older,
• meet criteria for opioid dependence as measured by the Mini-SCID, and
• have a positive urine toxicology for opiates.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Yale University

New Haven, Connecticut, 06510, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

Related Publications (4)

• 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.

  PMID: 25919527 RESULT

• 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.

  PMID: 28815789 RESULT

• 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.

  PMID: 28194688 RESULT

• 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.

  PMID: 36063082 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Gail D'Onofrio, MD, MS
• Organization: Yale University

gail.donofrio@yale.edu

203-785-4404

Study Officials

• Gail D'Onofrio, MD, MS

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2009
• First Posted: June 4, 2009
• Study Start: September 1, 2008
• Primary Completion: August 1, 2013
• Study Completion: December 1, 2014
• Last Updated: March 24, 2020
• Results First Posted: May 28, 2015

Record last verified: 2020-03

Locations

US (2)