Youth Opioid Recovery Support: A Developmentally-specific Intervention for Home Delivery of Extended Release Naltrexone
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 26 |
| Updated: | 1/13/2019 |
| Start Date: | February 1, 2018 |
| End Date: | December 1, 2019 |
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.
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.
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).
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).
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
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