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SafetyNet Program for Opioid Use Disorder (OUD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04253782
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : March 20, 2020
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Yale University

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. 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 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 our 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.

Condition or disease Intervention/treatment Phase
Opioid-Use Disorder (OUD) Other: Team Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Study personnel (recovery coaches + health educators) will form teams and meet with participants, who will 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. Throughout the study, participants may switch to any other option. It is important to emphasize that 1)-3) are not separate arms to be tested, compared, or analyzed. This is especially true, given that participants may switch from 1)-3) at any time. Instead, all enrolled participants are in a single arm once they agree to study participation.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Tiered Safety Net Following Naloxone Resuscitation From Opioid Overdose
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
Experimental: Team Intervention Arm
Recovery coaches and trained health educators will team together and meet with participants at least twice to provide support. This includes access to mediation-assisted therapy, trained mental healthcare providers, and educational resources.
Other: Team Intervention

The Team will meet with participants at their residences (or a location of their choosing) 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.





Primary Outcome Measures :
  1. Frequency of positive urine tests at 30 days (chart review) [ Time Frame: 30 days post intervention ]
    Frequency of positive urine tests at 30 days after intervention (data obtained via chart review)

  2. Frequency of positive urine tests at 180 days (chart review) [ Time Frame: 180 days post intervention ]
    Frequency of positive urine tests at 180 days after intervention (data obtained via chart review)

  3. Frequency of positive urine tests at 30 days (self-report) [ Time Frame: 30 days post intervention ]
    Frequency of positive urine tests at 30 days after intervention (data obtained via self-report)

  4. Frequency of positive urine tests at 180 days (self-report) [ Time Frame: 180 days post intervention ]
    Frequency of positive urine tests at 180 days after intervention (data obtained via self-report)


Secondary Outcome Measures :
  1. Percentage of positive urine tests at 30 days (chart review) [ Time Frame: 30 days post intervention ]
    Percentage of positive urine tests at 30 days after intervention (data obtained via chart review)

  2. Percentage of positive urine tests at 180 days (chart review) [ Time Frame: 180 days post intervention ]
    Percentage of positive urine tests at 180 days after intervention (data obtained via chart review)

  3. Percentage of positive urine tests at 30 days (self-report) [ Time Frame: 30 days post intervention ]
    Percentage of positive urine tests at 30 days after intervention (data obtained via chart review)

  4. Percentage of positive urine tests at 180 days (self-report) [ Time Frame: 180 days post intervention ]
    Percentage of positive urine tests at 180 days after intervention (data obtained via self-report)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Greater than or equal to 18 years of age
  • Screen positive for opioid use disorder (OUD) using mini international neuropsychiatric interview (MINI) (if applicable); must be within 7 days of consent to trial participation
  • At least 1 opioid overdose requiring resuscitation by naloxone + transport to the emergency department (ED); must be within 7 days of consent to trial participation
  • Positive for OUD using a health questionnaire containing questions about prescription opioid and heroin use; must be within 7 days of consent to trial participation
  • Provide self-consent for study participation

Exclusion Criteria:

  • Non-opioid overdose explanation for decreased level of conscientiousness, miosis, or decreased respiratory rate
  • Critically ill state (e.g., actively suicidal, psychotic, septic, and/or experiencing cardiac arrest)
  • Permanent residence is a long-term care/skilled nursing facility
  • Require immediate hospitalization for a medical or psychiatric condition
  • Homicidal
  • Simultaneously enrolled in another study whose principal investigator (PI) or co-PI is a faculty member in the Department of Emergency Medicine at Yale
  • Enrolled in opioid agonist treatment for OUD at the time of the ED visit
  • In police custody or incarcerated (at the time of consent to participate or any known time after)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253782


Contacts
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Contact: Sandy Bogucki, MD, PhD +1 (203) 785-6159 sandy.bogucki@yale.edu
Contact: Carolyn Brokowski, PhD(in prog) 1(860)874-6249 carolyn.brokowski@yale.edu

Locations
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United States, Connecticut
Yale New Haven Hospital, 20 York Street
New Haven, Connecticut, United States, 06510
Contact: Carolyn E Brokowski, PhD(in prog)         
Yale New Haven Hospital, Saint Raphael Campus, 1450 Chapel Street
New Haven, Connecticut, United States, 06511
Contact: Carolyn E Brokowski, PhD(in prog.)         
Sponsors and Collaborators
Yale University
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Sandy Bogucki, MD, PhD Yale University School of Medicine, Yale New Haven Hospital
Publications:
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)
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)
Kaplan l, Nugent C, Baker M, Clark HW, Veysey BM. Introduction: The recovery community services program. Alcoholism Treatment Quarterly 28: 244-255, 2010.
CONNECTICUT COMMUNITY FOR ADDICTION RECOVERY (CCAR). What is a recovery coach? https://addictionrecoverytraining.org/recovery-coach-academy/ (Accessed 01/27/2020)
CONNECTICUT COMMUNITY FOR ADDICTION RECOVERY (CCAR). Recovery Coach Academy © https://addictionrecoverytraining.org/recovery-coach-academy/ (Accessed 01/27/2020)
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)
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)
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)
Yale University Section of EMS. Yale PRIDE. http://www.pride-ems.org/myself/ (Accessed 01/27/2020)

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04253782    
Other Study ID Numbers: 2000027149
R01CE002989-01 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yale University:
Community Healthcare
Emergency Medicine
Addictions Recovery
Substance Abuse
Opioid Overdose
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders