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

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ClinicalTrials.gov Identifier: NCT00913770
Recruitment Status : Completed
First Posted : June 4, 2009
Results First Posted : May 28, 2015
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE June 1, 2009
First Posted Date  ICMJE June 4, 2009
Results First Submitted Date  ICMJE May 11, 2015
Results First Posted Date  ICMJE May 28, 2015
Last Update Posted Date March 24, 2020
Study Start Date  ICMJE September 2008
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
Self-reported engagement in formal substance abuse treatment at 30 days, verified by contact with the treatment program [ Time Frame: 30 days post intake ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2015)
Days of Self-reported Illicit Opioid Use in the Past 7 Days [ Time Frame: 30 days post randomization ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
  • Changes in opioid use (self-report and urine toxicology analysis) [ Time Frame: 30 days, 2, 6 and 12 months post intake ]
  • HIV risk behaviors [ Time Frame: 30 days, 2, 6 and 12 months post intake ]
  • Health care service utilization [ Time Frame: 30 days, 2, 6 and 12 months post intake ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Models of Screening, Brief Intervention With a Facilitated Referral to Treatment (SBIRT) for Opioid Patients in the Emergency Department
Official Title  ICMJE Models of Screening, Brief Intervention With a Facilitated Referral to Treatment (SBIRT) for Opioid Patients in the Emergency Department
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Opiate Addiction
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 9, 2013)
329
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2009)
360
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00913770
Other Study ID Numbers  ICMJE 0808004132
1R01DA025991-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Gail D'Onofrio, MD, MS Yale University
PRS Account Yale University
Verification Date March 2020

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