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Youth Opioid Recovery Support: A Developmentally-specific Intervention for Home Delivery of Extended Release Naltrexone

NCT03306368 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-09-23

No results posted yet for this study

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. 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.

Conditions

  • Opioid-Related Disorders

Interventions

BEHAVIORAL

Youth Opioid Recovery Support

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.

Sponsors & Collaborators

  • Potomac Health Foundations

    lead OTHER

Principal Investigators

  • Marc J Fishman, MD · Mountain Manor Treatment Center

  • Marc Fishman, MD · Potomac Health Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
26 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2019-06-01
Completion
2019-12-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03306368 on ClinicalTrials.gov