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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00913770
First received: June 1, 2009
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

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 Intervention
Opiate Addiction
Other: Brief Intervention with Buprenorphine initiation
Behavioral: Brief Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Self-reported engagement in formal substance abuse treatment at 30 days, verified by contact with the treatment program [ Time Frame: 30 days post intake ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in opioid use (self-report and urine toxicology analysis) [ Time Frame: 30 days, 2, 6 and 12 months post intake ] [ Designated as safety issue: No ]
  • HIV risk behaviors [ Time Frame: 30 days, 2, 6 and 12 months post intake ] [ Designated as safety issue: No ]
  • Health care service utilization [ Time Frame: 30 days, 2, 6 and 12 months post intake ] [ Designated as safety issue: No ]

Enrollment: 329
Study Start Date: September 2008
Estimated Study Completion Date: December 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: SC
Standard Care
Experimental: SBIRT
Screening, Brief Intervention and Facilitated Referral to Treatment
Behavioral: 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.
Experimental: SBI+Bup
Screening, Brief Intervention and Buprenorphine initiation
Other: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00913770

Locations
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06510
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Gail D'Onofrio, MD, MS Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00913770     History of Changes
Other Study ID Numbers: 1R01DA025991-01, 1R01DA025991-01
Study First Received: June 1, 2009
Last Updated: July 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
opioid dependence
buprenorphine
brief intervention

Additional relevant MeSH terms:
Emergencies
Behavior, Addictive
Opioid-Related Disorders
Disease Attributes
Pathologic Processes
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists

ClinicalTrials.gov processed this record on August 26, 2014