SafetyNet Program for Opioid Use Disorder (OUD)

NCT04253782 | Completed Results DMC

• 3 other identifiers: 2000028548R01CE002989-012000027149
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 2

Brief Summary

The principal aim of this study is to determine whether a novel biopsychosocial intervention following opioid overdose (OD) affects 1) the frequency of secondary opioid OD events and 2) the proportion of individuals who remain engaged in treatment for opioid use disorder (OUD) or are in remission at 30 days and at 180 days post intervention. Remission is defined as engagement in daily medication-assisted therapy (MAT)-typically buprenorphine/naloxone (BUP) or methadone- and/or a recovery capital score of ≥ 27.5. The intervention principally involves connecting OUD-affected individuals with community resources, including BUP-, other MAT-, and education-related services. To carry out the intervention, an addiction recovery coach and an appropriately trained health educator paramedic (research assistant) will form a Team and perform follow-up visits (electronically/remotely and/or by phone and/or in person, when appropriate) after a participant has experienced at least 1 opioid OD requiring naloxone resuscitation. Our hypothesis is that the intervention will decrease subsequent OD events and increase the likelihood of remission. To evaluate this hypothesis, data will be collected from self-report and from EPIC, Yale New Haven Hospital's medical record system. The secondary aim is to determine whether the intervention affects 1) the frequency of positive-urine tests for opioids and 2) the frequency and proportion of subjects self-reporting opioid use. Our hypothesis is that this intervention will decrease both. Data from the entire cohort will be compared in aggregate with patients who were started on BUP in the ED over the same time period and with historic controls.

Conditions

Opioid-Use Disorder (OUD)

Keywords

Community Healthcare; Emergency Medicine; Addiction Recovery; Substance Misuse; Opioid Overdose

Outcome Measures

Primary Outcomes (8)

• Frequency of Positive Urine Tests at 30 Days (Chart Review)

  Count of positive urine tests at 30 days after intervention per patient (data obtained via chart review)

  30 days post intervention

• Frequency of Positive Urine Tests at 180 Days (Chart Review)

  Count of positive urine tests at 180 days after intervention per patient (data obtained via chart review)

  180 days post intervention

• Frequency of Emergency Department Overdose(s) at 30 Days (Chart Review)

  Count of Emergency Department Overdose(s) at 30 days after intervention per patient (data obtained via chart review)

  30 days post intervention

• Frequency of Emergency Department Overdose(s) at 180 Days (Chart Review)

  Count of Emergency Department Overdose(s) at 180 days after intervention per patient (data obtained via chart review)

  180 days post intervention

• Percentage of Patients Engaged in Medication Assisted Therapy (MAT) Within 180 Days (Chart Review)

  Percentage of patients engaged in Medication Assisted Therapy (MAT) within 180 days after intervention (data obtained via chart review)

  180 days post intervention

• Percentage of Patients With Any Use of Suboxone Within 180 Days (Chart Review)

  Percentage of patients with any use of Suboxone within 180 days after intervention (data obtained via chart review)

  180 days post intervention

• Frequency of Positive Urine Tests Within 30 Days (Self-report)

  Frequency of positive urine tests within 30 days after intervention (data obtained via self-report)

  30 days post intervention

• Frequency of Positive Urine Tests Within 180 Days (Self-report)

  Frequency of positive urine tests within 180 days after intervention (data obtained via self-report)

  180 days post intervention

Secondary Outcomes (4)

• Percentage of Positive Urine Tests at 30 Days (Chart Review)

  30 days post intervention

• Percentage of Positive Urine Tests at 180 Days (Chart Review)

  180 days post intervention

• Percentage of Positive Urine Tests Within 30 Days (Self-report)

  30 days post intervention

• Percentage of Positive Urine Tests Within 180 Days (Self-report)

  180 days post intervention

Study Arms (1)

Team Intervention Arm

EXPERIMENTAL

Recovery coaches and trained health educators will team together and meet with participants (remotely/electronically and/or by phone or in person, when appropriate) at least twice and for a maximum of 7 times. This includes access to mediation, trained mental healthcare providers, and educational resources.

Other: Team Intervention

Interventions

Team Intervention OTHER

The Team will meet with participants (remotely/electronically and/or by phone) and will ask that they select one of three options that may help with opioid addiction: 1. treatment with buprenorphine/naloxone (BUP), 2. inpatient, 12-step, or methadone regimens, or 3. education only (materials provided by the CT Community for Addiction Recovery (CCAR)). Throughout the study, participants may switch to any other option.

Team Intervention Arm

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years
• Screen positive for opioid use disorder (OUD)
• Screen positive for OUD using the mini international neuropsychiatric interview (MINI)
• At least 1 opioid overdose requiring resuscitation by naloxone or equivalent
• No non-opioid overdose explanation for decreased level of consciousness, miosis, or decreased respiratory rate
• Positive for OUD using a health questionnaire containing questions about prescription opioid and heroin use
• Not in a critically ill state at the time of consent (e.g., not actively suicidal, psychotic, septic, nor cardiac arrest; nor any combination; nor equivalent)
• Not homicidal
• Able to self-consent to program/study participation
• Permanent residence is not a long-term care facility
• No simultaneous enrollment in another study whose principal investigator (PI) or co-PI is a faculty member in the Department of Emergency Medicine at the Yale School of Medicine
• Not prescribed opioids for acute pain, chronic pain, or palliative care without OUD diagnosis
• Not stably enrolled in opioid agonist treatment for OUD at the time of the ED visit
• Neither in police custody nor incarcerated nor both; nor equivalent; \*parolees and those on probation may be enrolled incidentally, but are not the target population of this work
• Refused buprenorphine/naloxone (BUP), if offered

You may not qualify if:

• \<18 years
• Screen negative for OUD
• Screen negative for OUD using the mini international neuropsychiatric interview (MINI)
• No evidence of documented opioid overdose requiring resuscitation by naloxone or equivalent
• Non-opioid overdose explanation for decreased level of consciousness, miosis, or decreased respiratory rate
• Negative for OUD using a health questionnaire containing questions about prescription opioid and heroin use
• In a critically ill state (e.g., actively suicidal, psychotic, septic, or in cardiac arrest; any combination; or equivalent) at the time of consent
• Homicidal
• Unable to self-consent to program/study participation
• Permanent resident of a long-term care facility
• Simultaneous enrollment in another study whose principal investigator (PI) or co-PI is a faculty member in the Department of Emergency Medicine
• Prescribed opioids for acute pain, chronic pain, or palliative care without OUD
• Stably enrolled in opioid agonist treatment or other medication-assisted therapy for OUD at the time of consent
• In police custody and/or incarcerated or equivalent; \*parolees and those on probation may be enrolled incidentally, but are not the target population of this work
• On BUP treatment

Sponsors & Collaborators

• Yale University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (2)

Yale New Haven Hospital, 20 York Street

New Haven, Connecticut, 06510, United States

Location

Yale New Haven Hospital, Saint Raphael Campus, 1450 Chapel Street

New Haven, Connecticut, 06511, United States

Location

Related Publications (16)

• 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.

  PMID: 25919527 BACKGROUND

• Dugosh K, Abraham A, Seymour B, McLoyd K, Chalk M, Festinger D. A Systematic Review on the Use of Psychosocial Interventions in Conjunction With Medications for the Treatment of Opioid Addiction. J Addict Med. 2016 Mar-Apr;10(2):93-103. doi: 10.1097/ADM.0000000000000193.

  PMID: 26808307 BACKGROUND

• Amorim P, Lecrubier Y, Weiller E, Hergueta T, Sheehan D. DSM-IH-R Psychotic Disorders: procedural validity of the Mini International Neuropsychiatric Interview (MINI). Concordance and causes for discordance with the CIDI. Eur Psychiatry. 1998;13(1):26-34. doi: 10.1016/S0924-9338(97)86748-X.

  PMID: 19698595 BACKGROUND

• Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.

  PMID: 9881538 BACKGROUND

• Substance Abuse and Mental Health Services Administration. SAMHSA's working definition of recovery: 10 guiding principles of recovery. 2012. PEP12-RECDEF https://store.samhsa.gov/system/files/pep12-recdef.pdf (Accessed 1/27/2020)

  BACKGROUND

• Substance Abuse and Mental Health Services Administration (SAMHSA). What are peer recovery support services? US Department of Health and Human Services; HHS Publication SMA 09-4454. http://www.samhsa.gov/recovery/peer-support-social-inclusion (Accessed 01/27/2020)

  BACKGROUND

• Kaplan l, Nugent C, Baker M, Clark HW, Veysey BM. Introduction: The recovery community services program. Alcoholism Treatment Quarterly 28: 244-255, 2010.

  BACKGROUND

• CONNECTICUT COMMUNITY FOR ADDICTION RECOVERY (CCAR). What is a recovery coach? https://addictionrecoverytraining.org/recovery-coach-academy/ (Accessed 01/27/2020)

  BACKGROUND

• CONNECTICUT COMMUNITY FOR ADDICTION RECOVERY (CCAR). Recovery Coach Academy © https://addictionrecoverytraining.org/recovery-coach-academy/ (Accessed 01/27/2020)

  BACKGROUND

• Capozzi J. Heroin epidemic: As deaths rise, program a 'glimmer of hope' for life. myPalmBeachPost. https://www.palmbeachpost.com/news/heroin-epidemic-deaths-rise-program-glimmer-hope-for-life/c8ITU5Q2lJbVFfEjSZKwpK/ (Accessed 01/27/2020)

  BACKGROUND

• Tracy K, Wallace SP. Benefits of peer support groups in the treatment of addiction. Subst Abuse Rehabil. 2016 Sep 29;7:143-154. doi: 10.2147/SAR.S81535. eCollection 2016.

  PMID: 27729825 BACKGROUND

• Hayes M. Fairfield County program targets opioid addiction. This Week Community News; Dec 12, 2017. http://www.thisweeknews.com/news/20171212/fairfield-county-program-targets-opioid-addiction (Accessed 01/27/2020)

  BACKGROUND

• Rienzi G. Johns Hopkins pilots study on EMS treatment of substance abusers. Johns Hopkins University Gazette. Sept-Oct 2014. https://hub.jhu.edu/gazette/2014/september-october/focus-baltimore-city-ems/ (Accessed 01/27/2020)

  BACKGROUND

• Cone DC, Ahern J, Lee CH, Baker D, Murphy T, Bogucki S. A descriptive study of the "lift-assist" call. Prehosp Emerg Care. 2013 Jan-Mar;17(1):51-6. doi: 10.3109/10903127.2012.717168. Epub 2012 Sep 12.

  PMID: 22971148 BACKGROUND

• Yale University Section of EMS. Yale PRIDE. http://www.pride-ems.org/myself/ (Accessed 01/27/2020)

  BACKGROUND

• Boscarino JA, Kirchner HL, Pitcavage JM, Nadipelli VR, Ronquest NA, Fitzpatrick MH, Han JJ. Factors associated with opioid overdose: a 10-year retrospective study of patients in a large integrated health care system. Subst Abuse Rehabil. 2016 Sep 16;7:131-141. doi: 10.2147/SAR.S108302. eCollection 2016.

  PMID: 27695382 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders; Opiate Overdose

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drug Overdose; Prescription Drug Misuse; Drug Misuse

Results Point of Contact

• Title: Daniel Joseph, MD
• Organization: Yale School of Medicine

daniel.joseph@yale.edu

(203) 785-4404

Study Officials

• Daniel Joseph, MD

  Yale University School of Medicine, Yale New Haven Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study personnel (recovery coaches + health educators) will form teams and meet (mostly remotely/electronically and/or by phone) with participants, who will select one of three options that may help with opioid misuse: 1. treatment with buprenorphine/naloxone (BUP), 2. methadone maintenance, intensive outpatient, or residential treatments, or 3. education only. Throughout the study, participants may switch to any other option.

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: February 5, 2020
• Study Start: July 1, 2020
• Primary Completion: April 20, 2022
• Study Completion: April 20, 2022
• Last Updated: October 18, 2024
• Results First Posted: October 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)