Measures to Improve Outcomes After an Opioid Overdose
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|ClinicalTrials.gov Identifier: NCT03968237|
Recruitment Status : Not yet recruiting
First Posted : May 30, 2019
Last Update Posted : June 3, 2019
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
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|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|
- Drug: Buprenorphine/Naloxone
Controlled substancesOther Names:
- 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.
- 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.
- 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.
- Demographic Data [ Time Frame: at screening ]The investigator will collect the demographic data of the population served by this protocol.
- 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).
- Urine Drug Screen [ Time Frame: up to 6 months ]Percentage of urine toxicology positive for illicit drug and opioid use.
- 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.
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): NCT03968237
|Contact: Pooja Amin||(434)email@example.com|
|Contact: Tracie Kostelac||(434)firstname.lastname@example.org|
|Principal Investigator:||Nassima Ait-Daoud Tiouririne, M.D.||University of Virginia|