Opioid-Related DisordersYORSNCT03306368
Youth Opioid Recovery Support: A Developmentally-specific Intervention for Home Delivery of Extended Release Naltrexone
A study testing Youth Opioid Recovery Support in people with Opioid-Related Disorders, run by Potomac Health Foundations at 1 site in United States.
Trial summary
Opioid addiction among youth (including both adolescents and young adults) is a growing health problem with catastrophic consequences for young people and their families. The current opioid epidemic disproportionately affects youth. Read more about this study
- Who is it for?
- Ages 18 to 26 years
- Conditions the study is for
- Opioid-Related Disorders
- What is being tested?
- Youth Opioid Recovery Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 1 Dec 2019
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Young adults age 18-26 with OUD who present for an index episode of residential/inpatient opioid detoxification and seek treatment with XR-NTX at Mountain Manor Treatment Center (MMTC).
Who cannot join
- Liver function tests (LFTs) > 5x upper limit of normal
- Psychiatric or medical instability (eg suicidailty, psychosis, Sickle Cell disease with frequent crises, etc) that would preclude participation in the trial
- Living situation (location greater than 60 miles from the center, homelessness) that would preclude participation in the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Mountain Manor Treatment Center
Baltimore, Maryland, 21229
About this study
Opioid addiction among youth (including both adolescents and young adults) is a growing health problem with catastrophic consequences for young people and their families. The current opioid epidemic disproportionately affects youth. Furthermore, compared to adults, adolescents and young adults tend to have poorer engagement in and response to treatment than older adults. Relapse prevention medications are the clear standard of care for the treatment of opioid addiction in adults, but the evidence base for effectiveness including implementation is not well-established in youth, and concerns from the field emphasize poor adherence and retention. Further there is no consensus regarding models of care, psychosocial treatments and platforms for delivery of medications. Extended release naltrexone (XR-NTX) has proven effectiveness in adults and is a promising pharmacotherapy for youth, but the field needs further clarification of its optimal use and delivery in this target population, in the context of developmentally informed models of care. There is inadequate current capacity for specialty opioid specific treatment that integrates pharmacotherapy (relapse prevention medication) with psychosocial treatment in a context that is youth welcoming and family empowering.
Read the detailed description
While retention in youth opioid treatment has generally been poor, assertive outreach has not been standard. There may be models from other populations with elements worth considering, such as Assertive Community Treatment (ACT) for severe and persistent mental illness or Assertive Continuing Care (ACC) for adolescents with cannabis use disorders. These are programs providing wrap-around services that include home-based services and medication administration visits, assertive outreach, intense case management, family engagement in order to address engagement barriers. ACC has considerable developmental validity, has been used widely and been scaled by SAMHSA in broad implementations for youth SUDs (other than OUD). ACT has become a broad standard of care for adults with chronic severe mental illness such as schizophrenia, who struggle with non-adherence and poor outcomes in conventional treatment. ACT also typically includes a medication home-delivery component. Most states have also developed standard public sector reimbursement models for ACT. But very little work has been done to adapt or adopt these models to the population of youth with opioid addiction.
Furthermore, limitations on adherence to XR-NTX under non-research conditions have been a barrier to optimal effectiveness. One study reported that among 62 adult patients completing inpatient detoxification who received an XR-NTX prior to discharge, 55% returned for a second injection and 16% received a third injection. In the LA County evaluation, only 17% of the 171 adults who received an XR-NTX injection received their third injection. The investigators' first case series of 16 youth receiving XR-NTX for opioid addiction, the average total number of outpatient doses received within 4 months of outpatient treatment was 1.5, corresponding to 38% of the potential 4 monthly doses, with 25% dropping out before receiving any outpatient doses. A naturalistic study published by the investigators, of young adult opioid treatment with either buprenorphine or XR-NTX and high intensity psychosocial treatment support included 13 cases treated with XR-NTX. This cohort had 40% retention at 6 months, no difference between the buprenorphine and XR-NTX groups, with an average number of 3.1 outpatient doses received within 6 months, corresponding to 52% of the potential 6 monthly doses. And while 54% received a 3rd outpatient dose, this was a low-volume program that selected highly motivated patients willing to accept the requirements and burdens of frequent attendance and intensive structure, and included only those who had initiated outpatient treatment following inpatient treatment.
To address these gaps discussed above, the investigators propose N=45 (~5 pilot intervention cases prior to randomization; see protocol) participants with OUD to be randomized to treatment as usual (TAU) or YORs intervention, which incorporates XR-NTX into a developmentally informed, multi-component model of care - Youth Opioid Recovery Support (YORS; see protocol for additional detail on the intervention).
- Conditions
- Opioid-Related Disorders
- Being tested
- Youth Opioid Recovery Support
- Keywords
- OUD, XR-NTX, assertive outreach, youth
- 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.
Youth Opioid Recovery SupportBehavioural
The components of the Youth Opioid Recovery Support intervention are:
XR-NTX, home delivery of XR-NTX, the family framework approach engages and empowers families, assertive continuing care incorporates outreach, home delivery of XR-NTX, contingency management.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual (TAU) | No intervention | Participants receiving treatment as usual post-residential detox. TAU clinic-based treatment receiving standard clinic-based XR-NTX. |
| Youth Opioid Recovery Support (YORS) | Experimental | Youth Opioid Recovery Support consists of the following component:
Home delivery of XR-NTX, family framework, assertive continuing care incorporates outreach, home delivery of evidence based psychosocial treatment and case management in a model that specifically targets engagement and motivation in youth, contingency management. Receives: Behavioral: Youth Opioid Recovery Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of weeks retained in treatment
# of weeks participant remains in treatment after discharge from inpatient care
Measured: Treatment week 1 to 24 weeks
Number of weeks negative for opioid use
Number of weeks participant tests negative for opiates and reports no use of opiates.
Measured: Treatment week 1 to 24 weeks
Secondary outcomes (3)
Number of patients who linked to after care
Percent of patients who successfully link to after care from inpatient to outpatient will be calculated using total number of patients who linked over total number of patients referred.
Measured: Treatment week 0 to treatment week 4
Number of XR-NTX doses received
Total number of XR-NTX doses received within 24 weeks
Measured: Treatment week 1 to 24 weeks
Number of weeks negative for substances other than opiates
Number of weeks participant tests negative for substances other than opiates and reports no use of other illicit substances.
Measured: Treatment week 1 to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start1 Feb 2018
- Primary completion1 Jun 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Opioid-Related DisordersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Potomac Health Foundations
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc J Fishman, MD, Principal investigator, Mountain Manor Treatment CenterMarc Fishman, MD, Principal investigator, Potomac Health Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306368
- Sponsor's protocol ID
- IRB00144092
- Acronym
- YORS
- Status last verified
- Sep 2021
- First submitted
- 2 Oct 2017
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vo HT, Robbins E, Westwood M, Lezama D, Fishman M. Relapse prevention medications in community treatment for young adults with opioid addiction. Subst Abus. 2016 Jul-Sep;37(3):392-397. doi: 10.1080/08897077.2016.1143435. Epub 2016 Jan 28.
PubMed 26820059Vo HT, Burgower R, Rozenberg I, Fishman M. Home-based delivery of XR-NTX in youth with opioid addiction. J Subst Abuse Treat. 2018 Feb;85:84-89. doi: 10.1016/j.jsat.2017.08.007. Epub 2017 Aug 31.
PubMed 28867062Fishman MJ, Winstanley EL, Curran E, Garrett S, Subramaniam G. Treatment of opioid dependence in adolescents and young adults with extended release naltrexone: preliminary case-series and feasibility. Addiction. 2010 Sep;105(9):1669-76. doi: 10.1111/j.1360-0443.2010.03015.x. Epub 2010 Jul 9.
PubMed 20626723Wenzel K, Fishman M. Mobile van delivery of extended-release buprenorphine and extended-release naltrexone for youth with OUD: An adaptation to the COVID-19 emergency. J Subst Abuse Treat. 2021 Jan;120:108149. doi: 10.1016/j.jsat.2020.108149. Epub 2020 Sep 24.
PubMed 33303086Wenzel K, Selby V, Wildberger J, Lavorato L, Thomas J, Fishman M. Choice of extended release medication for OUD in young adults (buprenorphine or naltrexone): A pilot enhancement of the Youth Opioid Recovery Support (YORS) intervention. J Subst Abuse Treat. 2021 Jun;125:108306. doi: 10.1016/j.jsat.2021.108306. Epub 2021 Jan 26.
PubMed 34016297Fishman M, Wenzel K, Vo H, Wildberger J, Burgower R. A pilot randomized controlled trial of assertive treatment including family involvement and home delivery of medication for young adults with opioid use disorder. Addiction. 2021 Mar;116(3):548-557. doi: 10.1111/add.15181. Epub 2020 Aug 4.
PubMed 32621368
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Youth Opioid Recovery Support: A Developmentally-specific Intervention for Home Delivery of Extended Release Naltrexone
- ClinicalTrials.gov ID
- NCT03306368
- Acronym / sponsor ID
- YORS / IRB00144092
- Conditions
- Opioid-Related Disorders
- Keywords
- OUD, XR-NTX, assertive outreach, youth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Potomac Health FoundationsUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 11 Oct 2017 (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 among youth (including both adolescents and young adults) is a growing health problem with catastrophic consequences for young people and their families. The current opioid epidemic disproportionately affects youth. Furthermore, compared to adults, adolescents and young adults tend to have poorer engagement in and response to treatment than older adults. Relapse prevention medications are the clear standard of care for the treatment of opioid addiction in adults, but the evidence base for effectiveness including implementation is not well-established in youth, and concerns from the field emphasize poor adherence and retention. Further there is no consensus regarding models of care, psychosocial treatments and platforms for delivery of medications. Extended release naltrexone (XR-NTX) has proven effectiveness in adults and is a promising pharmacotherapy for youth, but the field needs further clarification of its optimal use and delivery in this target population, in the context of developmentally informed models of care. There is inadequate current capacity for specialty opioid specific treatment that integrates pharmacotherapy (relapse prevention medication) with psychosocial treatment in a context that is youth welcoming and family empowering.
Detailed description
While retention in youth opioid treatment has generally been poor, assertive outreach has not been standard. There may be models from other populations with elements worth considering, such as Assertive Community Treatment (ACT) for severe and persistent mental illness or Assertive Continuing Care (ACC) for adolescents with cannabis use disorders. These are programs providing wrap-around services that include home-based services and medication administration visits, assertive outreach, intense case management, family engagement in order to address engagement barriers. ACC has considerable developmental validity, has been used widely and been scaled by SAMHSA in broad implementations for youth SUDs (other than OUD). ACT has become a broad standard of care for adults with chronic severe mental illness such as schizophrenia, who struggle with non-adherence and poor outcomes in conventional treatment. ACT also typically includes a medication home-delivery component. Most states have also developed standard public sector reimbursement models for ACT. But very little work has been done to adapt or adopt these models to the population of youth with opioid addiction.
Furthermore, limitations on adherence to XR-NTX under non-research conditions have been a barrier to optimal effectiveness. One study reported that among 62 adult patients completing inpatient detoxification who received an XR-NTX prior to discharge, 55% returned for a second injection and 16% received a third injection. In the LA County evaluation, only 17% of the 171 adults who received an XR-NTX injection received their third injection. The investigators' first case series of 16 youth receiving XR-NTX for opioid addiction, the average total number of outpatient doses received within 4 months of outpatient treatment was 1.5, corresponding to 38% of the potential 4 monthly doses, with 25% dropping out before receiving any outpatient doses. A naturalistic study published by the investigators, of young adult opioid treatment with either buprenorphine or XR-NTX and high intensity psychosocial treatment support included 13 cases treated with XR-NTX. This cohort had 40% retention at 6 months, no difference between the buprenorphine and XR-NTX groups, with an average number of 3.1 outpatient doses received within 6 months, corresponding to 52% of the potential 6 monthly doses. And while 54% received a 3rd outpatient dose, this was a low-volume program that selected highly motivated patients willing to accept the requirements and burdens of frequent attendance and intensive structure, and included only those who had initiated outpatient treatment following inpatient treatment.
To address these gaps discussed above, the investigators propose N=45 (~5 pilot intervention cases prior to randomization; see protocol) participants with OUD to be randomized to treatment as usual (TAU) or YORs intervention, which incorporates XR-NTX into a developmentally informed, multi-component model of care - Youth Opioid Recovery Support (YORS; see protocol for additional detail on the intervention).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual (TAU) | No intervention | –Participants receiving treatment as usual post-residential detox. TAU clinic-based treatment receiving standard clinic-based XR-NTX. |
| Youth Opioid Recovery Support (YORS) | Experimental | Behavioral: Youth Opioid Recovery SupportYouth Opioid Recovery Support consists of the following component: Home delivery of XR-NTX, family framework, assertive continuing care incorporates outreach, home delivery of evidence based psychosocial treatment and case management in a model that specifically targets engagement and motivation in youth, contingency management. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Young adults age 18-26 with OUD who present for an index episode of residential/inpatient opioid detoxification and seek treatment with XR-NTX at Mountain Manor Treatment Center (MMTC).
Key exclusion criteria (3 listed)
- Liver function tests (LFTs) > 5x upper limit of normal
- Psychiatric or medical instability (eg suicidailty, psychosis, Sickle Cell disease with frequent crises, etc) that would preclude participation in the trial
- Living situation (location greater than 60 miles from the center, homelessness) that would preclude participation in the trial
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 SupportThe components of the Youth Opioid Recovery Support intervention are: XR-NTX, home delivery of XR-NTX, the family framework approach engages and empowers families, assertive continuing care incorporates outreach, home delivery of XR-NTX, contingency management. | Behavioural | Youth Opioid Recovery Support (YORS) |
Primary outcome
Number of weeks retained in treatment
Time frame: Treatment week 1 to 24 weeks
# of weeks participant remains in treatment after discharge from inpatient care
Number of weeks negative for opioid use
Time frame: Treatment week 1 to 24 weeks
Number of weeks participant tests negative for opiates and reports no use of opiates.
3 secondary outcomes
Number of patients who linked to after care
Time frame: Treatment week 0 to treatment week 4
Number of XR-NTX doses received
Time frame: Treatment week 1 to 24 weeks
Number of weeks negative for substances other than opiates
Time frame: Treatment week 1 to 24 weeks
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 23 Sep 2021.
- Background: PubMed 26820059Vo HT, Robbins E, Westwood M, Lezama D, Fishman M. Relapse prevention medications in community treatment for young adults with opioid addiction. Subst Abus. 2016 Jul-Sep;37(3):392-397. doi: 10.1080/08897077.2016.1143435. Epub 2016 Jan 28.
- Background: PubMed 28867062Vo HT, Burgower R, Rozenberg I, Fishman M. Home-based delivery of XR-NTX in youth with opioid addiction. J Subst Abuse Treat. 2018 Feb;85:84-89. doi: 10.1016/j.jsat.2017.08.007. Epub 2017 Aug 31.
- Background: PubMed 20626723Fishman MJ, Winstanley EL, Curran E, Garrett S, Subramaniam G. Treatment of opioid dependence in adolescents and young adults with extended release naltrexone: preliminary case-series and feasibility. Addiction. 2010 Sep;105(9):1669-76. doi: 10.1111/j.1360-0443.2010.03015.x. Epub 2010 Jul 9.
- Background: PubMed 33303086Wenzel K, Fishman M. Mobile van delivery of extended-release buprenorphine and extended-release naltrexone for youth with OUD: An adaptation to the COVID-19 emergency. J Subst Abuse Treat. 2021 Jan;120:108149. doi: 10.1016/j.jsat.2020.108149. Epub 2020 Sep 24.
- Background: PubMed 34016297Wenzel K, Selby V, Wildberger J, Lavorato L, Thomas J, Fishman M. Choice of extended release medication for OUD in young adults (buprenorphine or naltrexone): A pilot enhancement of the Youth Opioid Recovery Support (YORS) intervention. J Subst Abuse Treat. 2021 Jun;125:108306. doi: 10.1016/j.jsat.2021.108306. Epub 2021 Jan 26.
- Results publication: PubMed 32621368Fishman M, Wenzel K, Vo H, Wildberger J, Burgower R. A pilot randomized controlled trial of assertive treatment including family involvement and home delivery of medication for young adults with opioid use disorder. Addiction. 2021 Mar;116(3):548-557. doi: 10.1111/add.15181. Epub 2020 Aug 4.
- Individual participant dataSharing planned: Undecided
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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 J Fishman, MD principal investigator
Mountain Manor Treatment Center
Marc Fishman, MD principal investigator
Potomac Health Foundation
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 in people with Opioid-Related Disorders, run by Potomac Health Foundations 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 23 Sep 2021. 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?
Number of weeks retained in treatment (time frame: Treatment week 1 to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03306368, which also lists 6 linked publications.
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 23 Sep 2021.