Clinical trial NCT00913770: Models of Screening, Brief Intervention With a Facilitated Referral to Treatment (SBIRT) for Opioid Patients in the Emergency Department
Official title: Models of Screening, Brief Intervention With a Facilitated Referral to Treatment (SBIRT) for Opioid Patients in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opiate Addiction
Keywords: opioid dependence
buprenorphine
brief intervention
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2009-06-04
Enrollment: 329
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Self-reported Engagement in Formal Substance Abuse Treatment at 30 Days (Verified by Contact With the Treatment Program)
timeFrame: 30 days post randomization
Secondary outcomes:
measure: Days of Self-reported Illicit Opioid Use in the Past 7 Days
timeFrame: 30 days post randomization
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Gail D'Onofrio, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.