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.

Public Health Relevance

Opioid dependence is a major public health concern and remains primarily an untreated medical condition in the United States. In 2006, approximately 560,000 individuals used heroin and 11.4 million individuals used prescription opioids for non-medical reasons. The economic costs of opioid dependence, estimated at greater than $21 billion/year, have far reaching implications for the individual, workplace, society and the healthcare system. Treatment is associated with substantial individual and societal benefits;and the Emergency Department visit, often the opioid dependent patient's only contact with the medical system, is a unique opportunity for screening, intervention and referral to treatment.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
5R01DA025991-05
Application #
8282975
Study Section
Special Emphasis Panel (ZDA1-JXR-D (12))
Program Officer
Aklin, Will
Project Start
2008-09-30
Project End
2014-06-30
Budget Start
2012-07-01
Budget End
2014-06-30
Support Year
5
Fiscal Year
2012
Total Cost
$650,599
Indirect Cost
$257,488
Name
Yale University
Department
Emergency Medicine
Type
Schools of Medicine
DUNS #
043207562
City
New Haven
State
CT
Country
United States
Zip Code
06520
Hawk, Kathryn; D'Onofrio, Gail; Fiellin, David A et al. (2018) Past-year Prescription Drug Monitoring Program Opioid Prescriptions and Self-reported Opioid Use in an Emergency Department Population With Opioid Use Disorder. Acad Emerg Med 25:508-516
D'Onofrio, Gail; Chawarski, Marek C; O'Connor, Patrick G et al. (2017) Emergency Department-Initiated Buprenorphine for Opioid Dependence with Continuation in Primary Care: Outcomes During and After Intervention. J Gen Intern Med 32:660-666
Busch, Susan H; Fiellin, David A; Chawarski, Marek C et al. (2017) Cost-effectiveness of emergency department-initiated treatment for opioid dependence. Addiction 112:2002-2010
Pantalon, Michael V; Dziura, James; Li, Fang-Yong et al. (2017) An interventionist adherence scale for a specialized brief negotiation interview focused on treatment engagement for opioid use disorders. Subst Abus 38:191-199
Bernstein, Steven L; D'Onofrio, Gail (2017) Screening, treatment initiation, and referral for substance use disorders. Addict Sci Clin Pract 12:18
D'Onofrio, Gail; O'Connor, Patrick G; Pantalon, Michael V et al. (2015) Emergency department-initiated buprenorphine/naloxone treatment for opioid dependence: a randomized clinical trial. JAMA 313:1636-44
Greenwald, Mark K; Comer, Sandra D; Fiellin, David A (2014) Buprenorphine maintenance and mu-opioid receptor availability in the treatment of opioid use disorder: implications for clinical use and policy. Drug Alcohol Depend 144:1-11
Bernstein, Steven L; D'Onofrio, Gail (2013) A promising approach for emergency departments to care for patients with substance use and behavioral disorders. Health Aff (Millwood) 32:2122-8
Wang, Karen H; Becker, William C; Fiellin, David A (2013) Prevalence and correlates for nonmedical use of prescription opioids among urban and rural residents. Drug Alcohol Depend 127:156-62
Moore, Brent A; Fazzino, Tera; Barry, Declan T et al. (2013) The Recovery Line: A pilot trial of automated, telephone-based treatment for continued drug use in methadone maintenance. J Subst Abuse Treat 45:63-9

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