Substance Use DisordersLINCS UP: RCTNCT05847621
Linking Individuals Needing Care for Substance Use Disorders to Peer Coaches
A study testing Peer recovery coaching with linkage to recovery resources in people with Substance Use Disorders, run by Emory University at 1 site in United States.
Trial summary
This is a 3-arm randomized controlled trial. Participants will be randomized via a maximally tolerated imbalance randomization procedure using NCI's Clinical Trial Randomization Tool with 1:1:1 allocation to each group: in-person peer recovery coaching (PRC) with linkage to recovery resources, telemedicine-based peer… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Peer recovery coaching with linkage to recovery resources
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2024to 30 Sep 2025
- 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
- ED patient or hospitalized through the ED within last 24 hours
- Age 18 years or older
- Able to speak and understand English
- Clinically sober, able to provide informed consent
- Score of 3 or greater - "moderate level", "substantial level", or "severe level" of problems related to drug abuse - on Drug Abuse Screening Test (DAST-10).(103, 104)
- Willing to follow study procedures and complete research follow-up calls
- Have at least one reliable contact number
Who cannot join
- Medically or psychiatrically unstable as determined by treating physician
- Prisoner or in police custody
- Prior participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Linking Individuals Needing Care for Substance Use Disorders in Urban Emergency Departments to Peer Coaches (LINCS UP): RCT Component
This is a 3-arm randomized controlled trial. Participants will be randomized via a maximally tolerated imbalance randomization procedure using NCI's Clinical Trial Randomization Tool with 1:1:1 allocation to each group: in-person peer recovery coaching (PRC) with linkage to recovery resources, telemedicine-based peer recovery coaching with linkage to recovery resources, or usual care.
In the PRC arms, PRCs will meet patients at bedside (in person) or via a tablet-based video call (telemedicine). They will assess the participant's state of change, engage in motivational interviewing techniques, and link the participant to community-based recovery resources according to the needs of the participant. They will also schedule and perform follow up calls after the participant is discharged from the ED to provide ongoing support and facilitate re-linkage to recovery resources, if needed.
Read more
Participants in the usual care arm will be provided with a list of community recovery resources, but there will be no PRC interaction or direct linkage to resources through the study.
Follow up visits will take place at 7, 30, and 90 days after enrollment. Most will take place via telephone, but participants will be given the option of an in-person visit if they so desire.
Read the detailed description
Deaths from drug overdose have risen to record levels since the onset of the COVID-19 pandemic, disproportionately impacting Black individuals and people experiencing homelessness. Fewer than one-third of the 8.3 million individuals living with an illicit drug use disorder in 2019 reported receiving treatment. Telemedicine services have increased access to care for many patients living with substance use disorders (SUD), but the long-term role of this treatment approach in SUD care is uncertain. Multifaceted strategies are needed to build recovery capital and link vulnerable individuals to recovery resources.
Emergency department (ED) visits are an opportunity to screen for SUDs, initiate treatment, and link to recovery resources. Observational studies have noted that consultation with a peer recovery coach (PRC) was well-received in EDs, with high rates of engagement and satisfaction. PRCs facilitate conversations allowing patients to express their ideal pathway to recovery, provide linkage to services across the social ecology, and follow up to support recovery, including re-linkage to resources as needed. Nonetheless, their role in ED screening and linkage to resources, including the potential role of telemedicine, has not been rigorously evaluated.
The investigators will conduct a randomized controlled trial enrolling 600 subjects across three arms: in-person peer coaching with linkage to recovery support services and callbacks, telemedicine-based peer coaching with linkage and callbacks, or usual care. Results will inform other EDs considering a peer recovery coach program for patients presenting with SUD-related conditions. By utilizing telemedicine, this model will be rapidly scalable and readily implemented at other facilities.
- Conditions
- Substance Use Disorders
- Being tested
- Peer recovery coaching with linkage to recovery resources, Usual Care
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer recovery coaching with linkage to recovery resourcesBehavioural
Peer recovery coach (PRC) assessment of the participant's state of change, engage in motivational interviewing techniques, and link the participant to community-based recovery resources according to the needs of the participant. They will also schedule and perform follow up calls after the participant is discharged from the ED to provide ongoing support and facilitate re-linkage to recovery resources, if needed.
Usual CareBehavioural
Participants will be provided with a list of community recovery resources.
| Study group | Role | What they receive |
|---|---|---|
| In-person peer recovery coaching with linkage to recovery resources | Experimental | PRCs will meet patients at bedside (in person). They will also schedule and perform follow up calls after the participant is discharged from the ED to provide ongoing support and facilitate re-linkage to recovery resources, if needed.
Follow-up data collection on day 7, 30, 90 post discharge. Receives: Behavioral: Peer recovery coaching with linkage to recovery resources |
| Telemedicine-based peer recovery coaching with linkage to recovery resources | Experimental | PRCs will meet patients via a tablet-based video call (telemedicine). They will also schedule and perform follow up calls after the participant is discharged from the ED to provide ongoing support and facilitate re-linkage to recovery resources, if needed.
Follow-up data collection on day 7, 30, 90 post discharge. Receives: Behavioral: Peer recovery coaching with linkage to recovery resources |
| Usual Care | Active comparator | Participants in the usual care arm will be provided with a list of community recovery resources. No callbacks or re-linkage to recovery resources.
Follow-up data collection on day 7, 30, 90 post discharge. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of participants with successful linkage to at least one recovery resource
Change in number of participants with successful linkage to at least one recovery resource (formal addiction treatment, Recovery Community Organization (RCO), or harm reduction organization) at 30 days and 90 days after enrollment.
Measured: Baseline, 30 and 90 days after enrollment
Secondary outcomes (11)
Change in Brief Assessment of Recovery Capital (BARC-10)
This outcome will be evaluated obtaining a score on a scale. The range of possible responses is 10-60. Higher score correlates with better outcome.
Measured: Baseline, 7, 30, and 90 days after enrollment
Change in number of successful engagements with PRC after ED visit
Change in number of successful engagements with PRC (peer recovery coach) after ED visit
Measured: Baseline, 7, 30, and 90 days after enrollment
Change in number of episodes of re-linkage to recovery resources
Change in number of episodes of re-linkage to recovery resources
Measured: Baseline, 7, 30, and 90 days post intervention
Self-reported substance use in last 30 days
Self-reported substance use in last 30 days as measured by Timeline Follow-back (TLFB). It will be reported in number of episodes per day.
Measured: Baseline, 30 and 90 days post intervention
Number of fatal overdose events
Number of fatal overdose events will be collected
Measured: 90 days post intervention
Number of nonfatal overdose events
Number of nonfatal overdose events will be collected
Measured: 90 days post intervention
Number of Emergency Department (ED) visits
Number of ED visits will be collected
Measured: 90 days post intervention
Number of hospitalizations
Number of hospitalizations will be collected
Measured: 90 days post intervention
Change in employment status
Choices include: disabled, employed 32 hours or more per week, employed less than 32 hours per week, full-time student, homemaker, on medical leave, only temporarily laid off/sick leave/maternity leave, other, part-time student, retired, unemployed, and unknown. This outcome would measure a change in employment status from any of the choices to another one.
Measured: 90 days post intervention
Change in number of participants based on Housing status
Housing status will be reported specifying one of the categories: apartment, Single family house, homeless, shelter, dormitory, multifamily house. Number of participants will be reported in each category at 0, 7, 30, 90 days post intervention.
Measured: Baseline, 7, 30, and 90 days post intervention
Change in Social connections and isolation score
Social isolation scores range from 0 to 4, with 0 representing the highest level of social isolation and 4 representing the lowest level.
Measured: Baseline, 7, 30, 90 days post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start16 Aug 2024
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Joseph Carpenter, Emory University
- Investigators
- Joseph E Carpenter, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847621
- Sponsor's protocol ID
- STUDY00005553
- Other IDs
- R01CE003509, 2025P009769
- Acronym
- LINCS UP: RCT
- Status last verified
- Dec 2025
- First submitted
- 27 Apr 2023
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing will be initiated upon written request to the PI and would ultimately be shared via a secure portal such as Microsoft OneDrive. Deidentified data files, the data dictionary, and the final protocol will be uploaded to the Emory Dataverse, which is a long-term repository offered through a partnership between Emory and the Odum Institute at the University of North Carolina and Chapel Hill. This repository has policies and procedures in place that will provide data access to qualified researchers, fully consistent with federal data sharing policies and applicable laws and regulations. Datasets are uniquely named with a persistent digital object identifier (DOI), and are downloadable directly through a web-based interface. Additional data documentation and de-identified data will be deposited for sharing along with data consistent with applicable laws and regulations. Submitted data will confirm with relevant data and terminology standards.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking Individuals Needing Care for Substance Use Disorders in Urban Emergency Departments to Peer Coaches (LINCS UP): RCT Component
- ClinicalTrials.gov ID
- NCT05847621
- Acronym / sponsor ID
- LINCS UP: RCT / STUDY00005553
- Conditions
- Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 3-arm randomized controlled trial. Participants will be randomized via a maximally tolerated imbalance randomization procedure using NCI's Clinical Trial Randomization Tool with 1:1:1 allocation to each group: in-person peer recovery coaching (PRC) with linkage to recovery resources, telemedicine-based peer recovery coaching with linkage to recovery resources, or usual care.
In the PRC arms, PRCs will meet patients at bedside (in person) or via a tablet-based video call (telemedicine). They will assess the participant's state of change, engage in motivational interviewing techniques, and link the participant to community-based recovery resources according to the needs of the participant. They will also schedule and perform follow up calls after the participant is discharged from the ED to provide ongoing support and facilitate re-linkage to recovery resources, if needed.
Participants in the usual care arm will be provided with a list of community recovery resources, but there will be no PRC interaction or direct linkage to resources through the study.
Follow up visits will take place at 7, 30, and 90 days after enrollment. Most will take place via telephone, but participants will be given the option of an in-person visit if they so desire.
Detailed description
Deaths from drug overdose have risen to record levels since the onset of the COVID-19 pandemic, disproportionately impacting Black individuals and people experiencing homelessness. Fewer than one-third of the 8.3 million individuals living with an illicit drug use disorder in 2019 reported receiving treatment. Telemedicine services have increased access to care for many patients living with substance use disorders (SUD), but the long-term role of this treatment approach in SUD care is uncertain. Multifaceted strategies are needed to build recovery capital and link vulnerable individuals to recovery resources.
Emergency department (ED) visits are an opportunity to screen for SUDs, initiate treatment, and link to recovery resources. Observational studies have noted that consultation with a peer recovery coach (PRC) was well-received in EDs, with high rates of engagement and satisfaction. PRCs facilitate conversations allowing patients to express their ideal pathway to recovery, provide linkage to services across the social ecology, and follow up to support recovery, including re-linkage to resources as needed. Nonetheless, their role in ED screening and linkage to resources, including the potential role of telemedicine, has not been rigorously evaluated.
The investigators will conduct a randomized controlled trial enrolling 600 subjects across three arms: in-person peer coaching with linkage to recovery support services and callbacks, telemedicine-based peer coaching with linkage and callbacks, or usual care. Results will inform other EDs considering a peer recovery coach program for patients presenting with SUD-related conditions. By utilizing telemedicine, this model will be rapidly scalable and readily implemented at other facilities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| In-person peer recovery coaching with linkage to recovery resources | Experimental | Behavioral: Peer recovery coaching with linkage to recovery resourcesPRCs will meet patients at bedside (in person). They will also schedule and perform follow up calls after the participant is discharged from the ED to provide ongoing support and facilitate re-linkage to recovery resources, if needed. Follow-up data collection on day 7, 30, 90 post discharge. |
| Telemedicine-based peer recovery coaching with linkage to recovery resources | Experimental | Behavioral: Peer recovery coaching with linkage to recovery resourcesPRCs will meet patients via a tablet-based video call (telemedicine). They will also schedule and perform follow up calls after the participant is discharged from the ED to provide ongoing support and facilitate re-linkage to recovery resources, if needed. Follow-up data collection on day 7, 30, 90 post discharge. |
| Usual Care | Active comparator | Behavioral: Usual CareParticipants in the usual care arm will be provided with a list of community recovery resources. No callbacks or re-linkage to recovery resources. Follow-up data collection on day 7, 30, 90 post discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ED patient or hospitalized through the ED within last 24 hours
- Age 18 years or older
- Able to speak and understand English
- Clinically sober, able to provide informed consent
- Score of 3 or greater - "moderate level", "substantial level", or "severe level" of problems related to drug abuse - on Drug Abuse Screening Test (DAST-10).(103, 104)
Key exclusion criteria (3 listed)
- Medically or psychiatrically unstable as determined by treating physician
- Prisoner or in police custody
- Prior participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer recovery coaching with linkage to recovery resourcesPeer recovery coach (PRC) assessment of the participant's state of change, engage in motivational interviewing techniques, and link the participant to community-based recovery resources according to the needs of the participant. They will also schedule and perform follow up calls after the participant is discharged from the ED to provide ongoing support and facilitate re-linkage to recovery resources, if needed. | Behavioural | In-person peer recovery coaching with linkage to recovery resources, Telemedicine-based peer recovery coaching with linkage to recovery resources |
| Usual CareParticipants will be provided with a list of community recovery resources. | Behavioural | Usual Care |
Primary outcome
Change in number of participants with successful linkage to at least one recovery resource
Time frame: Baseline, 30 and 90 days after enrollment
Change in number of participants with successful linkage to at least one recovery resource (formal addiction treatment, Recovery Community Organization (RCO), or harm reduction organization) at 30 days and 90 days after enrollment.
11 secondary outcomes
Change in Brief Assessment of Recovery Capital (BARC-10)
Time frame: Baseline, 7, 30, and 90 days after enrollment
Change in number of successful engagements with PRC after ED visit
Time frame: Baseline, 7, 30, and 90 days after enrollment
Change in number of episodes of re-linkage to recovery resources
Time frame: Baseline, 7, 30, and 90 days post intervention
Self-reported substance use in last 30 days
Time frame: Baseline, 30 and 90 days post intervention
Number of fatal overdose events
Time frame: 90 days post intervention
Number of nonfatal overdose events
Time frame: 90 days post intervention
Number of Emergency Department (ED) visits
Time frame: 90 days post intervention
Number of hospitalizations
Time frame: 90 days post intervention
Change in employment status
Time frame: 90 days post intervention
Change in number of participants based on Housing status
Time frame: Baseline, 7, 30, and 90 days post intervention
Change in Social connections and isolation score
Time frame: Baseline, 7, 30, 90 days post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: Yes. Data sharing will be initiated upon written request to the PI and would ultimately be shared via a secure portal such as Microsoft OneDrive. Deidentified data files, the data dictionary, and the final protocol will be uploaded to the Emory Dataverse, which is a long-term repository offered through a partnership between Emory and the Odum Institute at the University of North Carolina and Chapel Hill. This repository has policies and procedures in place that will provide data access to qualified researchers, fully consistent with federal data sharing policies and applicable laws and regulations. Datasets are uniquely named with a persistent digital object identifier (DOI), and are downloadable directly through a web-based interface. Additional data documentation and de-identified data will be deposited for sharing along with data consistent with applicable laws and regulations. Submitted data will confirm with relevant data and terminology standards.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph E Carpenter, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer recovery coaching with linkage to recovery resources in people with Substance Use Disorders, 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 7 inclusion and 3 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 17 Dec 2025. 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 participants with successful linkage to at least one recovery resource (time frame: Baseline, 30 and 90 days after enrollment). 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 17 Dec 2025.