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Trial record 70 of 186 for:    BUPRENORPHINE AND NALOXONE

Measures to Improve Outcomes After an Opioid Overdose

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. Identifier: NCT03968237
Recruitment Status : Not yet recruiting
First Posted : May 30, 2019
Last Update Posted : June 3, 2019
Information provided by (Responsible Party):
Nassima Ait-Daoud Tiouririne, University of Virginia

Brief Summary:

This is a pilot study that aims to develop good clinical practices to improve outcomes after an opioid overdose and transition of care from the Emergency Department (ED) into an Office Based Opioid Treatment (OBOT) clinic for patients with opioid overdose/Opioid Use Disorder (OUD). We intend to involve UVA Emergency Medicine and Medical Toxicology physicians with buprenorphine waiver or an interest in becoming waived at our institution to implement early initiation of buprenorphine protocol. We hope that this change in practice will result in better management of patients with OUD and opioid overdose, reduce relapse and improve engagement in addiction treatment.

Subjects who meet criteria will be consented in the ED and receive a buprenorphine/naloxone induction protocol, prior to discharge and referral to the OBOT clinic. Subjects who consent to take part in this study will be entered in a database to track their involvement in treatment (s) at UVA and or any opioid related UVA health visits including OPIOID OVERDOSE.

Condition or disease Intervention/treatment
Opioid Overdose Drug: Buprenorphine/Naloxone

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Other
Official Title: Measures to Improve Outcomes After an Opioid Overdose
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Buprenorphine/Naloxone
    Controlled substances
    Other Names:
    • Belbuca
    • Probuphine
    • Narcan

Primary Outcome Measures :
  1. Clinical Opiate Withdrawal Scale (COWS) [ Time Frame: at screening ]
    The COWS is an 11 item scale designed to be administered by a clinican. This tool is used to rate common signs and symptoms of opiate withdrawal and monitor these symptoms over time. Reduction in adverse events will be evaluated by the documentation of COWS scores right after administration of Naloxone, then buprenorphine/naloxone.

  2. Opioid Related Emergency Department (ED) Visits [ Time Frame: up to 30 days ]
    Reduce risk of opioid re-overdose following ED buprenorphine/naloxone induction protocol. This will be measured by calculating the percentage of opioid related visits to any ED at 7 days post discharge, at 30 days post discharge, and hospital admissions at 30 days discharge.

  3. Treatment Engagement [ Time Frame: up to 6 months ]
    Improve addiction treatment engagement for patients receiving ED buprenorphine/naloxone induction following opioid overdose. This will be measured by the number of ED patients scheduled for follow-up at the office based opioid treatment (OBOT) clinic versus number of patients that attend the scheduled first appointment and number of patients that continue to follow-up at the OBOT clinic at 30 days and at 6 months.

Secondary Outcome Measures :
  1. Demographic Data [ Time Frame: at screening ]
    The investigator will collect the demographic data of the population served by this protocol.

  2. Brief Addiction Monitor (BAM) [ Time Frame: up to 6 months ]
    Report of substance use and social and health outcomes. It is a 17 item, multidimensional questionnaire which assess three substance use disorder related aspects (risk factors for substance use, protective factors that support sobriety, and drug and alcohol use).

  3. Urine Drug Screen [ Time Frame: up to 6 months ]
    Percentage of urine toxicology positive for illicit drug and opioid use.

  4. HIV Risk-Taking Behavioral Scale HIV Risk-Taking Behavioral Scale [ Time Frame: up to 6 months ]
    Social and Health Outcomes. It is an 11 item validated scale for drug use and sexual behavior.

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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from Emergency Room Department

Inclusion Criteria:

  • Age 18 years or older
  • Person can read, write, and speak in English.
  • Presenting to the University of Virginia ED with opioid overdose and administration of naloxone either by EMS or in the ED.
  • Experiencing some withdrawal symptoms (COWS score of 12 or higher) or experiencing 3 of the following symptoms: tremor/twitching, irritability, joint or bone aches, bad chills or sweating, goose bumps
  • Express an interest in receiving a buprenorphine/naloxone induction with the goal to continue the same treatment outpatient

Exclusion Criteria:

  • Non-opioid substance overdose or overdose that does not respond to naloxone
  • Patients requiring admission secondary to medical or psychiatric complications
  • Patients on prescribed methadone
  • Women who are pregnant; This medication may precipitate opioid withdrawal in pregnant patients with opioid use disorder. Withdrawal can harm the placenta function, preterm labor, fetal convulsions (seizures), stunted fetal growth and fetal death during pregnancy.
  • Mothers who are breastfeeding
  • Persons under the age of 18
  • Persons not able to attend follow-up clinic visits
  • Persons not able to consent
  • Known allergy or sensitivity to buprenorphine

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 identifier (NCT number): NCT03968237

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Contact: Pooja Amin (434)243-0778
Contact: Tracie Kostelac (434)243-0563

Sponsors and Collaborators
Nassima Ait-Daoud Tiouririne
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Principal Investigator: Nassima Ait-Daoud Tiouririne, M.D. University of Virginia

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Responsible Party: Nassima Ait-Daoud Tiouririne, Associate Professor, Director of UVA Center for Leading Edge Addiction Research, University of Virginia Identifier: NCT03968237     History of Changes
Other Study ID Numbers: 21455
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Buprenorphine, Naloxone Drug Combination
Drug Overdose
Substance-Related Disorders
Chemically-Induced Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists