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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA025991-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SC | No Intervention | Standard Care | |
| SBIRT | Experimental | Screening, Brief Intervention and Facilitated Referral to Treatment |
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| SBI+Bup | Experimental | Screening, Brief Intervention and Buprenorphine initiation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Negotiation Interview (BNI) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Days of Self-reported Illicit Opioid Use in the Past 7 Days | 30 days post randomization |
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Inclusion Criteria:
Patients who present to the adult ED at Yale-New Haven Hospital (YNHH) who are:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gail D'Onofrio, MD, MS | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06510 | United States | ||
| Yale University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25919527 | Result | 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. | |
| 28815789 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Care | Standard Care including receiving a referral. |
| FG001 | SBIRT | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Buprenorphine Initiation | Drug |
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| New Haven |
| Connecticut |
| 06519 |
| United States |
| 28194688 | Result | 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. |
| 36063082 | Derived | 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. |
| FG002 | SBI+Bup | 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. |
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Baseline population description is the number of subjects randomized to study arm
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Care | Standard Care including receiving a referral. |
| BG001 | SBIRT | 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. |
| BG002 | SBI+Bup | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All subjects who were randomized to receive treatment were included in the primary analysis. 2 subjects were lost to follow up in the standard of care arm which is why 102 are included in the analysis instead of 104 | Posted | Mean | 95% Confidence Interval | Mean Number of Outpatient Visits | 30 days post randomization |
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| Secondary | Days of Self-reported Illicit Opioid Use in the Past 7 Days | All subjects who were randomized to receive treatment were included in the primary analysis. 2 subjects were lost to follow up in the standard of care arm which is why 102 are included in the analysis instead of 104 | Posted | Mean | 95% Confidence Interval | Mean Number of Days | 30 days post randomization |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Care | Standard Care including receiving a referral. | 0 | 104 | 0 | 104 | ||
| EG001 | SBIRT | 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. | 0 | 111 | 0 | 111 | ||
| EG002 | SBI+Bup | 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. | 0 | 114 | 0 | 114 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gail D'Onofrio, MD, MS | Yale University | 203-785-4404 | gail.donofrio@yale.edu |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Male |
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