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

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00913770
First received: June 1, 2009
Last updated: August 4, 2015
Last verified: August 2015

June 1, 2009
August 4, 2015
September 2008
August 2013   (final data collection date for primary outcome measure)
Self-reported Engagement in Formal Substance Abuse Treatment at 30 Days (Verified by Contact With the Treatment Program) [ Time Frame: 30 days post randomization ] [ Designated as safety issue: No ]
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.
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 ]
Complete list of historical versions of study NCT00913770 on ClinicalTrials.gov Archive Site
Days of Self-reported Illicit Opioid Use in the Past 7 Days [ Time Frame: 30 days post randomization ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Models of Screening, Brief Intervention With a Facilitated Referral to Treatment (SBIRT) for Opioid Patients in the Emergency Department
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Opiate Addiction
  • 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
  • No Intervention: SC
    Standard Care
  • Experimental: SBIRT
    Screening, Brief Intervention and Facilitated Referral to Treatment
    Intervention: Behavioral: Brief Negotiation Interview (BNI)
  • Experimental: SBI+Bup
    Screening, Brief Intervention and Buprenorphine initiation
    Interventions:
    • Behavioral: Brief Negotiation Interview (BNI)
    • Drug: Buprenorphine Initiation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
329
December 2014
August 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00913770
1R01DA025991-01, 1R01DA025991-01
No
Not Provided
Not Provided
Yale University
Yale University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Gail D'Onofrio, MD, MS Yale University
Yale University
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP