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OpenTrials
Completed

NCT Number: NCT00913770

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University, New Haven, Connecticut, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Buprenorphine Initiation

Drug

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 30 days post randomization

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2014
First posted
Jun 4, 2009
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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