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NCT03306368: YORS

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

Completed NA Last updated 23 September 2021
What this trial tests

NA trial testing Youth Opioid Recovery Support in Opioid-Related Disorders in 40 participants. Completed in 1 December 2019.

Timeline
1 February 2018
Primary endpoint
1 June 2019
1 December 2019

Quick facts

Lead sponsorPotomac Health Foundations
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment40
Start date1 February 2018
Primary completion1 June 2019
Estimated completion1 December 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Potomac Health Foundations

Who can join

Adults 18 to 26, any sex, with Opioid-Related Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Opioid-Related Disorders

Currently open trials in the same condition.

Other Potomac Health Foundations trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03306368.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing