An interventional study of Brief Negotiation Interview (BNI) and Buprenorphine Initiation in Opiate Addiction, sponsored by Yale University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-24.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
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.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 329 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
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Patients who present to the adult ED at Yale-New Haven Hospital (YNHH) who are:
Exclusion Criteria:
Standard Care
Screening, Brief Intervention and Facilitated Referral to Treatment
Behavioral: Brief Negotiation Interview (BNI)
Screening, Brief Intervention and Buprenorphine initiation
Behavioral: Brief Negotiation Interview (BNI) · Drug: Buprenorphine Initiation
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.
Self-reported Engagement in Formal Substance Abuse Treatment at 30 Days (Verified by Contact With the Treatment Program)
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.
Time frame: 30 days post randomization
Days of Self-reported Illicit Opioid Use in the Past 7 Days
Time frame: 30 days post randomization
| Milestone | Standard Care | SBIRT | SBI+Bup |
|---|---|---|---|
| Started | 104 | 111 | 114 |
| Completed | 69 | 82 | 93 |
| Not completed | 35 | 29 | 21 |
| Withdrew: Unable to contact | 24 | 19 | 13 |
| Withdrew: Refused | 11 | 10 | 8 |
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.
| Mean Number of Outpatient Visits | Standard Care | SBIRT | SBI+Bup |
|---|---|---|---|
| Self-reported Engagement in Formal Substance Abuse Treatment at 30 Days (Verified by Contact With the Treatment Program) | 4.99 (3.1 to 6.8) | 5.67 (4.0 to 7.4) | 3.71 (2.1 to 5.3) |
| Mean Number of Days | Standard Care | SBIRT | SBI+Bup |
|---|---|---|---|
| Days of Self-reported Illicit Opioid Use in the Past 7 Days | 2.3 (1.7 to 3.0) | 2.4 (1.8 to 3.0) | 0.9 (0.5 to 1.3) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Care | — | 0/104 (0%) | 0/104 (0%) |
| SBIRT | — | 0/111 (0%) | 0/111 (0%) |
| SBI+Bup | — | 0/114 (0%) | 0/114 (0%) |
Baseline population description is the number of subjects randomized to study arm
| Age, Continuous(years) | Standard Care | SBIRT | SBI+Bup | Total |
|---|---|---|---|---|
| Mean | 31.4 ± 10.6 | 31.9 ± 9.7 | 31 ± 9.8 | 31.4 ± 10.6 |
| Sex: Female, Male(Participants) | Standard Care | SBIRT | SBI+Bup | Total |
|---|---|---|---|---|
| Female | 23 | 27 | 28 | 78 |
| Male | 81 | 84 | 86 | 251 |
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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