AzTrials
AzTrials

Opioid UseREAL TTIMENCT05711056

Rural Expanded Access to OUD Care & Linkage Using Toxicologists for Telehealth Initiated Treatment

A study testing Sociobehavioral Intervention in people with Opioid Use and Opioid Abuse, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The overarching goal of this project is to increase the availability of OUD treatment in rural counties in the state of Georgia by using Emergency Department (ED)-based telehealth strategies to initiate MOUD and connect patients to treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Opioid Use, Opioid Abuse
What is being tested?
Sociobehavioral Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
163 participants
Where
1 siteUnited States
Study dates
30 Aug 2023to 31 Aug 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 years or older
  • English speaking
  • Clinically sober
  • Medically and psychiatrically stable

Who cannot join

  • Already receiving MAT or psychotherapy for OUD prior to ED arrival
  • Prior participation in the study
  • Unable to provide informed consent
  • If their clinical condition worsens such that continued participation would be considered unsafe in the opinion of the PRC or ED staff
  • Prisoners
  • Individuals who are not yet adults (infants, children, teenagers)
  • Cognitively impaired or Individuals with Impaired Decision-Making Capacity
  • Individuals who are not able to clearly understand English

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Georgia Poison Center

    Atlanta, Georgia, 30303

Other trials in United States

About this study

Official title: Expanding Rural Access to Opioid Use Disorder Treatment Utilizing Medical Toxicologists and the Georgia Poison Center to Facilitate Emergency Department- and Telehealth-Based Medication Initiation and Linkage to Care

The overarching goal of this project is to increase the availability of OUD treatment in rural counties in the state of Georgia by using Emergency Department (ED)-based telehealth strategies to initiate MOUD and connect patients to treatment.

The investigators will implement a novel collaboration between rural EDs, medical toxicologists at the Georgia Poison Center (GPC), peer recovery coaches (PRCs) and RCOs throughout Georgia to bridge the gap between OUD treatment need in rural EDs and specialty physician availability at the GPC.

Research activities will be conducted during two broad phases, at three rural EDs in Georgia: planning and implementation. During the planning phase, aggregate data will be obtained to determine each ED's existing practices treating patients with OUD and opioid withdrawal. During the implementation phase, the researchers will prospectively study a poison center OUD consultation and PRC intervention as it is rolled out at each site, collecting participant-level data. Sites will be rolled into the implementation phase in a stepped-wedge fashion, so there will be times when some sites are in the planning phase while others are in the implementation phase.

Read the detailed description

Over the past two decades, death from opioid overdose has dramatically increased. Opioid use disorder (OUD) is a complex and debilitating chronic illness associated with serious medical complications. Effective treatment of OUD often requires long-term treatment with multiple therapies. Medications for opioid use disorder (MOUD), are the gold standard for OUD treatment, including buprenorphine. MOUD is underutilized, and treatment programs are in short supply, particularly in rural areas. Psychosocial and behavioral health interventions are also key factors in maintaining sobriety. The use of trained peer recovery coaches (PRCs) has been shown to increase both MOUD initiation and 30-day treatment retention. The goal of this project is to increase the availability of OUD treatment in rural counties Georgia by using ED-based telehealth strategies to initiate MOUD and connect patients to treatment by implementing a novel collaboration between rural EDs, medical toxicologists at the Georgia Poison Center (GPC), PRCs, and Recovery Community Organizations (RCOs).

The study population will include patients with OUD or opioid withdrawal that are 18 years or older, English speaking, clinically sober, and medically and psychiatrically stable, that present to a preselected rural ED in Candler, Carroll, Jefferson, Laurens, and Washington County. Pregnant patients are included as MOUD is standard of care and the sociobehavioral intervention is considered minimal risk.

This sociobehavioral intervention will utilize two primary evidence-based strategies: delivering OUD consultation via telemedicine, which has been demonstrated to be a safe and effective means for initiating MOUD with buprenorphine; and, incorporating psychosocial support in the form of PRC and linkage to outpatient care. An ED provider will evaluate the patient and if identified as someone with OUD or opioid withdrawal, the ED provider will call the GPC and be connected to the medical toxicologist on call. The toxicologist will assist the ED provider with initiation of MOUD. After the medical evaluation is complete, the ED provider will contact the virtual PRC. Once the PRC and the patient are introduced, the PRC will obtain verbal consent to participate in the study and allow for chart review and to follow up with the patient at 30-days to determine if they are still engaged with the outpatient program and/or maintained on MOUD.

Before consent is obtained, this will be a no-contact study. The research team will perform a retrospective chart review to identify demographic and historical information about patients that present to each rural ED with OUD or opioid withdrawal. The investigators will request this data from hospitals monthly and continuously over the study period. One the patient has been consented by the PRC, the investigators will request additional data to follow up with them and obtain information from the RCO and Prescription Drug Monitoring Program (PDMP). Data will be made publicly available through HRSA and will be submitted for publication in a peer reviewed journal. Data will not be identifiable. Research team members will have access to the data but will be required to complete HIPPA and CITI training. The research team will request a HIPPA waiver to access existing data from hospital systems about the patients who present to the ED with OUD or acute opioid withdrawal. The ED provider will interact with the patient and perform standard of care. They will contact the poison center to help with MOUD initiation. Then, the patient will be introduced to the virtual PRC, who will review the consent document. Regardless of consent, the patient will still be offered the intervention. The participant burden is minimal (time required to obtain consent). Data will be kept confidential, and deidentified when it is stored in ToxSentry (GPC electronic medical record) and in Emory One Drive (HIPPA complaint and secure).

Being tested
Sociobehavioral Intervention
Keywords
Opioid
Medical subject headings
Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sociobehavioral InterventionBehavioural

    Utilizes two primary evidence-based strategies:

    • Delivering OUD consultation via telemedicine, which has been demonstrated to be a safe and effective means for initiating MOUD with buprenorphine; and,
    • Incorporating psychosocial support in the form of PRC, whose involvement in patient care is associated with increased treatment retention and MOUD initiation.
Study groups in NCT05711056
Study groupRoleWhat they receive
Sociobehavioral program GroupExperimentalA novel sociobehavioral collaborative program that will improve the health of individuals in rural areas by expanding access to MOUD through an ED- based telemedicine strategy. Researchers will prospectively study a poison center OUD consultation and peer recovery coach (PRC) intervention as it is rolled out at each site, collecting participant-level data at baseline, one week post intervention and 30 days post intervention.
Receives: Behavioral: Sociobehavioral Intervention
Control GroupNo interventionPatients who are seen at a participating hospital prior to the initiation of the intervention will be considered controls.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in number of patients who present with acute opioid withdrawal, acute opioid overdose, or requesting treatment for OUD (Opioid Use Disorder)

    Change in number of patients who present with acute opioid withdrawal, acute opioid overdose, or requesting treatment for OUD will be collected

    Measured: Baseline, 3 months post intervention, and 1 year post intervention

  2. Change in number of patients evaluated for MOUD (Medication for Opioid Use Disorder)

    Change in number of patients evaluated for MOUD will be collected

    Measured: Baseline, 3 months post intervention, and 1 year post intervention

  3. Change in number of patients started on MOUD

    Change in number of patients started on MOUD will be collected

    Measured: Baseline, 3 months post intervention, and 1 year post intervention

  4. Change in number of patients discharged with a prescription for MOUD

    Change in number of patients discharged with a prescription for MOUD will be collected

    Measured: Baseline, 3 months post intervention, and 1 year post intervention

  5. Change in number of patients linked to a local RCO (Recovery Community Organization)

    Change in number of patients linked to a local RCO will be collected

    Measured: Baseline, 3 months post intervention, and 1 year post intervention

  6. Change in number of patients seen at local RCO after ED discharge

    Change in number of patients seen at local RCO after ED discharge will be collected

    Measured: Baseline, 3 months post intervention, and 1 year post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2023
  2. Study start30 Aug 2023
  3. Primary completion31 Aug 2026
  4. Study completion31 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05711056
Sponsor's protocol ID
STUDY00005086
Other IDs
G28RH46273-01-00, 2024P008011
Acronym
REAL TTIME
Status last verified
Oct 2026
First submitted
18 Jan 2023
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Sociobehavioral Intervention in people with Opioid Use and Opioid Abuse, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in number of patients who present with acute opioid withdrawal, acute opioid overdose, or requesting treatment for OUD (Opioid Use Disorder) (time frame: Baseline, 3 months post intervention, and 1 year post intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in