Overview

This trial is active, not recruiting.

Condition opiate addiction
Treatments brief intervention with buprenorphine initiation, brief intervention
Sponsor Yale University
Collaborator National Institute on Drug Abuse (NIDA)
Start date September 2008
End date August 2013
Trial size 329 participants
Trial identifier NCT00913770, 1R01DA025991-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(No Intervention)
Standard Care
(Experimental)
Screening, Brief Intervention and Facilitated Referral to Treatment
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)
Screening, Brief Intervention and Buprenorphine initiation
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.

Primary Outcomes

Measure
Self-reported engagement in formal substance abuse treatment at 30 days, verified by contact with the treatment program
time frame: 30 days post intake

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Models of Screening, Brief Intervention With a Facilitated Referral to Treatment (SBIRT) for Opioid Patients in the Emergency Department
Principal investigator Gail D'Onofrio, MD, MS
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by Yale University.