Opioid-Related DisordersYORSNCT04015115
Youth Opioid Recovery Support: Improving Care Systems
A study testing Youth Opioid Recovery Support service model in people with Opioid-Related Disorders, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Opioid addiction, also referred to as opioid use disorder, among young people is a growing health concern for patients and their families. Overdose deaths related to opioids have been steadily increasing in number and are at an all-time high. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid-Related Disorders
- What is being tested?
- Youth Opioid Recovery Support service model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2019to 31 Oct 2020
- 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 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young adults, ages 18-26, admitted to residential/inpatient addiction treatment
- Meets DSM-5 criteria for opioid use disorder
- Has used opioids other than specifically prescribed within 30 days prior to consent
- Has selected treatment with extended-release naltrexone or extended-release buprenorphine
- Is prescribed extended-release naltrexone or extended-release buprenorphine under the care of a Mountain Manor Treatment Center physician or nurse practitioner
- Willing to designate one or more family members of their choice to be involved with their treatment.
- Family Participant: must be at least 18 years old, be designated by the patient Participant, and willing to be involved in the treatment.
Who cannot join
- Living situation is beyond a reasonable travel distance from the treatment center
- Currently, in jail, prison, or any inpatient overnight facility as required by course of law or have a pending legal action which may prevent an individual from completing the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Mountain Manor Treatment Center
Baltimore, Maryland, 21229
About this study
Official title: Youth Opioid Recovery Support (YORS): Improving Care Systems for Young Adults With Opioid Use Disorder
Opioid addiction, also referred to as opioid use disorder, among young people is a growing health concern for patients and their families. Overdose deaths related to opioids have been steadily increasing in number and are at an all-time high. Opioid addiction has serious consequences such as getting HIV, legal problems, relationship problems, and unemployment.
Currently, there are two standard of care office-based medications available to treat opioid use disorder, buprenorphine and naltrexone. Naltrexone has been available for several years as an extended-release monthly injectable formulation, and more recently buprenorphine is as well. Both of these medications are typically administered in the medical office setting. Long-acting injection medications like these help people that may otherwise forget doses, skip doses, and relapse.
Read more
MAT that are FDA-approved such as these paired with counseling can help sustain recovery, but retention to treatment is a concern, especially among young adults. Many barriers arise for attending office-based treatment (e.g., transportation) often resulting in falling away from treatment and relapsing. Involvement of family members is often challenged by health care provider concerns about patient privacy, and existing relationship strain between patients and their families.
The Youth Opioid Recovery Support (YORS) treatment delivery model hopes to address barriers to retention to substance treatment among those with opioid use disorder who have already decided to get treatment with either extended-release naltrexone or extended-release buprenorphine. The YORS model involves: 1) home-delivery of standard-of-care medication and individual/family counseling services; 2) assertive outreach efforts by the treatment team; and 3) contingency management incentives upon receipt of treatment.
This service model has already shown promise in addressing barriers to treatment retention particularly difficulties with medication adherence in patients who were prescribed monthly injectable extended-release naltrexone. Now that extended-release buprenorphine is also available, broader MAT options provided in an assertive service delivery model may maximize treatment retention and recovery outcomes. Further, transitioning participants from home-based receipt of treatment to clinic-based care begins the translation to sustainable health care.
- Conditions
- Opioid-Related Disorders
- Being tested
- Youth Opioid Recovery Support service model
- Keywords
- Buprenorphine, Central Nervous System Depressants, Chemically-Induced Disorders, Community Mental Health Services, Drug Partial Agonism, Heroin Dependence, Medication Adherence, Mental Disorders, Naltrexone, Narcotic Antagonists, Narcotics, Opioid-Related Disorders, Opioid Substitution Treatment, Patient Compliance
- Medical subject headings
- Opioid-Related Disorders, Chemically-Induced Disorders, Heroin Dependence, Medication Adherence, Mental Disorders, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Youth Opioid Recovery Support service modelBehavioural
see arm 1 description
| Study group | Role | What they receive |
|---|---|---|
| Youth Opioid Recovery Support service model | Experimental | The components of the Youth Opioid Recovery Support service model includes 1) home-delivery of standard-of-care medication and individual/family counseling services; 2) assertive outreach efforts by the treatment team; and 3) contingency management incentives upon receipt of medication treatment. Receives: Behavioral: Youth Opioid Recovery Support service model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in medication-assisted treatment of opioid use disorder
Total number of outpatient doses of extended-release naltrexone or extended-release buprenorphine received by the participant between enrollment and the end of the study window
Measured: Measured every 4 weeks for the duration of enrollment, up to 36 weeks, by examining participants medical record.
Opioid relapse
Opioid Relapse is defined as 10 days of opioid use within a 28-day period. Days of opioid use are calculated using data from self report and urine toxicology with missing or positive urine specimens imputed as 5 days of use.
Measured: Self report and urine specimens will be collected every 2 weeks for the duration of enrollment, up to 36 weeks.
Total number of opioid positive drug screens
Urine drug screening will objectively determine opioid use or nonuse.
Measured: Every 2 weeks for the duration of enrollment, up to 36 weeks.
Secondary outcomes (2)
Change in behaviors related to recovery
Participant-reported behaviors associated with function (e.g., employment), legal involvement, HIV risk behavior, overdoses, and crisis utilization (emergency room visit, hospitalization, detoxification services).
Measured: Participants will be assessed at baseline (time of enrollment into the study), then, every 4 weeks, up to 36 weeks.
Continued receipt of care post-intervention
Receipt of medication-assisted treatment at the treatment center after the last dose of home-delivered medication.
Measured: Continued care will be assessed at one time-point 1 month following the YORS intervention period of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start26 Jul 2019
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victoria Selby, University of Maryland, Baltimore
- Investigators
- Marc Fishman, MD, Principal investigator, Mountain Manor Treatment CenterKevin Wenzel, PhD, Study director, Mountain Manor Treatment CenterVictoria Selby, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015115
- Sponsor's protocol ID
- HP-0085682
- Acronym
- YORS
- Status last verified
- Jan 2022
- First submitted
- 1 Jul 2019
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Youth Opioid Recovery Support (YORS): Improving Care Systems for Young Adults With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT04015115
- Acronym / sponsor ID
- YORS / HP-0085682
- Conditions
- Opioid-Related Disorders
- Keywords
- Buprenorphine, Central Nervous System Depressants, Chemically-Induced Disorders, Community Mental Health Services, Drug Partial Agonism, Heroin Dependence, Medication Adherence, Mental Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 26 Jul 2019 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 10 Jul 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.
Opioid addiction, also referred to as opioid use disorder, among young people is a growing health concern for patients and their families. Overdose deaths related to opioids have been steadily increasing in number and are at an all-time high. Opioid addiction has serious consequences such as getting HIV, legal problems, relationship problems, and unemployment.
Currently, there are two standard of care office-based medications available to treat opioid use disorder, buprenorphine and naltrexone. Naltrexone has been available for several years as an extended-release monthly injectable formulation, and more recently buprenorphine is as well. Both of these medications are typically administered in the medical office setting. Long-acting injection medications like these help people that may otherwise forget doses, skip doses, and relapse.
MAT that are FDA-approved such as these paired with counseling can help sustain recovery, but retention to treatment is a concern, especially among young adults. Many barriers arise for attending office-based treatment (e.g., transportation) often resulting in falling away from treatment and relapsing. Involvement of family members is often challenged by health care provider concerns about patient privacy, and existing relationship strain between patients and their families.
The Youth Opioid Recovery Support (YORS) treatment delivery model hopes to address barriers to retention to substance treatment among those with opioid use disorder who have already decided to get treatment with either extended-release naltrexone or extended-release buprenorphine. The YORS model involves: 1) home-delivery of standard-of-care medication and individual/family counseling services; 2) assertive outreach efforts by the treatment team; and 3) contingency management incentives upon receipt of treatment.
This service model has already shown promise in addressing barriers to treatment retention particularly difficulties with medication adherence in patients who were prescribed monthly injectable extended-release naltrexone. Now that extended-release buprenorphine is also available, broader MAT options provided in an assertive service delivery model may maximize treatment retention and recovery outcomes. Further, transitioning participants from home-based receipt of treatment to clinic-based care begins the translation to sustainable health care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Youth Opioid Recovery Support service model | Experimental | Behavioral: Youth Opioid Recovery Support service modelThe components of the Youth Opioid Recovery Support service model includes 1) home-delivery of standard-of-care medication and individual/family counseling services; 2) assertive outreach efforts by the treatment team; and 3) contingency management incentives upon receipt of medication treatment. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Young adults, ages 18-26, admitted to residential/inpatient addiction treatment
- Meets DSM-5 criteria for opioid use disorder
- Has used opioids other than specifically prescribed within 30 days prior to consent
- Has selected treatment with extended-release naltrexone or extended-release buprenorphine
- Is prescribed extended-release naltrexone or extended-release buprenorphine under the care of a Mountain Manor Treatment Center physician or nurse practitioner
Key exclusion criteria (2 listed)
- Living situation is beyond a reasonable travel distance from the treatment center
- Currently, in jail, prison, or any inpatient overnight facility as required by course of law or have a pending legal action which may prevent an individual from completing 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 |
|---|---|---|
| Youth Opioid Recovery Support service modelsee arm 1 description | Behavioural | Youth Opioid Recovery Support service model |
Primary outcome
Retention in medication-assisted treatment of opioid use disorder
Time frame: Measured every 4 weeks for the duration of enrollment, up to 36 weeks, by examining participants medical record.
Total number of outpatient doses of extended-release naltrexone or extended-release buprenorphine received by the participant between enrollment and the end of the study window
Opioid relapse
Time frame: Self report and urine specimens will be collected every 2 weeks for the duration of enrollment, up to 36 weeks.
Opioid Relapse is defined as 10 days of opioid use within a 28-day period. Days of opioid use are calculated using data from self report and urine toxicology with missing or positive urine specimens imputed as 5 days of use.
Total number of opioid positive drug screens
Time frame: Every 2 weeks for the duration of enrollment, up to 36 weeks.
Urine drug screening will objectively determine opioid use or nonuse.
2 secondary outcomes
Change in behaviors related to recovery
Time frame: Participants will be assessed at baseline (time of enrollment into the study), then, every 4 weeks, up to 36 weeks.
Continued receipt of care post-intervention
Time frame: Continued care will be assessed at one time-point 1 month following the YORS intervention period of the study.
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 7 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Marc Fishman, MD principal investigator
Mountain Manor Treatment Center
Kevin Wenzel, PhD study director
Mountain Manor Treatment Center
Victoria Selby, PhD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Youth Opioid Recovery Support service model in people with Opioid-Related Disorders, run by University of Maryland, Baltimore 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 2 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 7 Feb 2022. 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?
Retention in medication-assisted treatment of opioid use disorder (time frame: Measured every 4 weeks for the duration of enrollment, up to 36 weeks, by examining participants medical record.). The study lists 3 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 7 Feb 2022.