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WithdrawnNCT03968237Updated Jun 26, 2026

Measures to Improve Outcomes After an Opioid Overdose

An observational study in Opioid Overdose, sponsored by Nassima Ait-Daoud Tiouririne. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.

Sponsored by Nassima Ait-Daoud Tiouririne · Observational

Why this study was withdrawn
COVID-19 pandemic interfered with ability to conduct study.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Every patient who is seen in the ED for opioid overdose and has received naloxone either by emergency medical services (EMS) or in the ED will be eligible to participate in this study. When patient is alert, they will be asked if they would be interested in participating in the study and consented when appropriate. Patients will receive a buprenorphine/naloxone induction protocol, prior to discharge and referral to the OBOT clinic.

OBOT Follow-up The patient's follow-up care will take place at the OBOT clinic, supervised by an Addiction Medicine specialist (physician) with a buprenorphine-waiver and an license clinical social worker (LCSW). Scheduling of all OBOT visits during this study are in alignment with the OBOT standard of care, including frequency and duration of visits. A total of 10 visits will be scheduled over the course of 6 months.

Month 1:

Visit 1:

The first OBOT visit will last approximately 60 minutes and will entail the following:

A standard initial evaluation, urine drug screen, urine pregnancy test, method of contraception, administration of the Brief Addiction Monitor (BAM), HIV-Risk Taking Behavior Scale, discussion of treatment plan and goals, and buprenorphine/naloxone prescription from physician.

Visits 2 through 4:

Each visit will last between 16 minutes to 1 hour. During each visit, the following tasks will be accomplished:

The subject will be asked about their drug use, urine drug screen, urine pregnancy test, method of contraception, discussion of treatment progress and adherence to plan and goals, therapy, and buprenorphine/naloxone prescription from physician.

Month 2:

Visits 5 and 6:

Each visit will last between16 minutes to 1 hour. During each visit, the following tasks will be accomplished:

The subject will be asked about their drug use, urine drug screen, urine pregnancy test, method of contraception, discussion of treatment progress and adherence to plan and goals, therapy, administration of BAM and HIV-Risk Taking Scale once (either of Visit 5 or 6), HIV-Risk Taking Behavior Scale and buprenorphine/naloxone prescription from physician.

Months 3 to 6:

Visits 7 through 10:

Each visit will last between 16 minutes to 1 hour. During each visit, the following tasks will be accomplished:

The subject will be asked about their drug use, urine drug screen, urine pregnancy test, method of contraception, discussion of treatment progress and adherence to plan and goals, therapy, administration of BAM and HIV-Risk Taking Scale, and buprenorphine/naloxone prescription from physician.

02

Conditions studied

  • Opioid Overdose

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03

In context

Opiate Overdose

70 studies on the registry are indexed under Opiate Overdose; 11 are open to participants now.

Browse Opiate Overdose studies →

Lead sponsor

Nassima Ait-Daoud Tiouririne is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients from Emergency Room Department

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
0 participants (actual)
Patient registry
No

Interventions

  • DrugBuprenorphine/Naloxone

    Drug pages: Buprenorphine · Naloxone

    Controlled substances

    Also known as: Belbuca, Probuphine, Narcan

06

What researchers measure

Primary outcomes

  1. Clinical Opiate Withdrawal Scale (COWS)

    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.

    Time frame: at screening

  2. Opioid Related Emergency Department (ED) Visits

    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.

    Time frame: up to 30 days

  3. Treatment Engagement

    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.

    Time frame: up to 6 months

Secondary outcomes

  1. Demographic Data

    The investigator will collect the demographic data of the population served by this protocol.

    Time frame: at screening

  2. Brief Addiction Monitor (BAM)

    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).

    Time frame: up to 6 months

  3. Urine Drug Screen

    Percentage of urine toxicology positive for illicit drug and opioid use.

    Time frame: up to 6 months

  4. HIV Risk-Taking Behavioral Scale HIV Risk-Taking Behavioral Scale

    Social and Health Outcomes. It is an 11 item validated scale for drug use and sexual behavior.

    Time frame: up to 6 months

07

Study locations

1 site
  • UVA Center for Leading Edge Addiction Research
    Charlottesville, Virginia 22903, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2019 to primary completion in Dec 2021, 28 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 28, 2019
First posted
May 30, 2019
StartActual
Aug 1, 2019
Primary completionActual
Dec 1, 2021
CompletionActual
Dec 1, 2021
Last update
Jun 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03968237
Lead sponsor
Nassima Ait-Daoud Tiouririne
Responsible party
Nassima Ait-Daoud Tiouririne (Associate Professor, Director of UVA Center for Leading Edge Addiction Research, University of Virginia) — Sponsor-investigator
First posted
May 30, 2019
Start date
Aug 1, 2019
Primary completion
Dec 1, 2021
Completion
Dec 1, 2021
Last update
Jun 26, 2026

Study contacts

Nassima Ait-Daoud Tiouririne, M.D.
principal investigator · University of Virginia

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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