Opiate AbuseFORCENCT03798470
FAVOR Opioid Recovery Coaching Evaluation
A study testing Peer Addiction Counseling in people with Opiate Abuse and Opiate Overdose, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
The Emergency Department (ED) is an ideal location to identify patients in need of treatment for opioid addiction. A local non-profit community-based addiction recovery program, Faces and Voices of Recovery (FAVOR) utilizes a peer recovery coaching model applied to substance use disorders by identifying, training… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opiate Abuse, Opiate Overdose, Opioid-use Disorder
- What is being tested?
- Peer Addiction Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 31 Dec 2018
- 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
- Patients presenting to the ED with opioid overdose or withdrawal
Who cannot join
- Age <18
- Known pregnant female
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Greenville Health System
Greenville, South Carolina, 29605
About this study
The Emergency Department (ED) is an ideal location to identify patients in need of treatment for opioid addiction. A local non-profit community-based addiction recovery program, Faces and Voices of Recovery (FAVOR) utilizes a peer recovery coaching model applied to substance use disorders by identifying, training, credentialing and supervising individuals who have been in recovery for at least 2 years.
These peer recovery coaches become the primary workforce in this community-based model. FAVOR provides no-cost comprehensive services for addiction recovery. The investigators hypothesized that having FAVOR Recovery Coaches (FRC) evaluate patients during an ED visit for opioid overdose would result in a high degree of engagement from the patients and serve as an opportunity to begin treatment for addiction.
Read the detailed description
The Emergency Department (ED) is an ideal location to identify patients in need of treatment for opioid addiction. A local non-profit community-based addiction recovery program, Faces and Voices of Recovery (FAVOR) utilizes a peer recovery coaching model applied to substance use disorders by identifying, training, credentialing and supervising individuals who have been in recovery for at least 2 years.These peer recovery coaches become the primary workforce in this community-based model. FAVOR provides no-cost comprehensive services for addiction recovery. The investigators hypothesized that having FAVOR Recovery Coaches (FRC) evaluate patients during an ED visit for opioid overdose would result in a high degree of engagement from the patients and serve as an opportunity to begin treatment for addiction.
- Conditions
- Opiate Abuse, Opiate Overdose, Opioid-use Disorder
- Being tested
- Peer Addiction Counseling
- Keywords
- opioid, overdose
- Medical subject headings
- Opioid-Related Disorders, Opiate Overdose, Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Addiction CounselingBehavioural
Also called FAVOR counseling
After identification, a 24/7 on-call FRC was paged and met with the patient in the ED. The patients were offered recovery services at the bedside by the FRC. The research team members offered voluntary participation and obtained informed consent to enrolling a longitudinal study looking into the success of his intervention. Patients did not need to participate to be eligible for counseling and resources from AVOR. The FRCs counselled and engaged the patient along with the family to offer a variety of services including active recovery coaching, group treatment modalities, family support services and transportation. After he initial encounter in the ED, the FAVOR team re-engaged the participant by phone or in person the next day and gradually increasing intervals thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Experimental | Intervention with FAVOR peer recovery coaching. Patients identified in the ED as opioid overdose and enrolled in the current study. Receives: Behavioral: Peer Addiction Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with active involvement in recovery
Defined as: Patients who have had phone, email, or in-person contact with their FAVOR recovery coach after discharge from the Emergency Department.
Measured: One year
Secondary outcomes (1)
All-cause Mortality
Number of participants with death from any cause within the study period.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start1 Jan 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate AbuseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Collaborators
- FAVOR (Faces and Voices of Recovery) OF GREENVILLE, South Carolina Department of Alcohol and Other Drug Abuse Services
- Responsible party
- Sponsor
- Investigators
- Christopher Carey, MD, Principal investigator, Greenville Health System Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798470
- Sponsor's protocol ID
- Pro00073004
- Acronym
- FORCE
- Status last verified
- Oct 2024
- First submitted
- 24 Dec 2018
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data would be de-identified if shared.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FAVOR Opioid Recovery Coaching Evaluation
- ClinicalTrials.gov ID
- NCT03798470
- Acronym / sponsor ID
- FORCE / Pro00073004
- Conditions
- Opiate Abuse, Opiate Overdose, Opioid-use Disorder
- Keywords
- opioid, overdose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Collaborators
- FAVOR (Faces and Voices of Recovery) OF GREENVILLE, South Carolina Department of Alcohol and Other Drug Abuse Services
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 10 Jan 2019 (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.
The Emergency Department (ED) is an ideal location to identify patients in need of treatment for opioid addiction. A local non-profit community-based addiction recovery program, Faces and Voices of Recovery (FAVOR) utilizes a peer recovery coaching model applied to substance use disorders by identifying, training, credentialing and supervising individuals who have been in recovery for at least 2 years.
These peer recovery coaches become the primary workforce in this community-based model. FAVOR provides no-cost comprehensive services for addiction recovery. The investigators hypothesized that having FAVOR Recovery Coaches (FRC) evaluate patients during an ED visit for opioid overdose would result in a high degree of engagement from the patients and serve as an opportunity to begin treatment for addiction.
Detailed description
The Emergency Department (ED) is an ideal location to identify patients in need of treatment for opioid addiction. A local non-profit community-based addiction recovery program, Faces and Voices of Recovery (FAVOR) utilizes a peer recovery coaching model applied to substance use disorders by identifying, training, credentialing and supervising individuals who have been in recovery for at least 2 years.These peer recovery coaches become the primary workforce in this community-based model. FAVOR provides no-cost comprehensive services for addiction recovery. The investigators hypothesized that having FAVOR Recovery Coaches (FRC) evaluate patients during an ED visit for opioid overdose would result in a high degree of engagement from the patients and serve as an opportunity to begin treatment for addiction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | Experimental | Behavioral: Peer Addiction CounselingIntervention with FAVOR peer recovery coaching. Patients identified in the ED as opioid overdose and enrolled in the current study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients presenting to the ED with opioid overdose or withdrawal
Key exclusion criteria (3 listed)
- Age <18
- Known pregnant female
- Prisoners
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 Addiction CounselingAlso: FAVOR counselingAfter identification, a 24/7 on-call FRC was paged and met with the patient in the ED. The patients were offered recovery services at the bedside by the FRC. The research team members offered voluntary participation and obtained informed consent to enrolling a longitudinal study looking into the success of his intervention. Patients did not need to participate to be eligible for counseling and resources from AVOR. The FRCs counselled and engaged the patient along with the family to offer a variety of services including active recovery coaching, group treatment modalities, family support services and transportation. After he initial encounter in the ED, the FAVOR team re-engaged the participant by phone or in person the next day and gradually increasing intervals thereafter. | Behavioural | Cohort |
Primary outcome
Percentage of patients with active involvement in recovery
Time frame: One year
Defined as: Patients who have had phone, email, or in-person contact with their FAVOR recovery coach after discharge from the Emergency Department.
1 secondary outcome
All-cause Mortality
Time frame: One year
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 31 Oct 2024.
- Individual participant dataSharing planned: No. The data would be de-identified if shared.
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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.
Christopher Carey, MD principal investigator
Greenville Health System Emergency Medicine
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 Addiction Counseling in people with Opiate Abuse and Opiate Overdose, run by Prisma Health-Upstate 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 1 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 31 Oct 2024. 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?
Percentage of patients with active involvement in recovery (time frame: One year). 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 31 Oct 2024.