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Feasibility of Pediatric Emergency Department-Initiated Treatment for Adolescents With Opioid Use Disorder

NCT04737603 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-11-12

No results posted yet for this study

Summary

ED-initiated buprenorphine with brief intervention and facilitated referral to treatment has been shown to be highly successful in increasing treatment engagement rates and reducing opioid use among adults. It is unknown whether this intervention is similarly effective for adolescents with OUD. To rigorously examine this important clinical research question, it is first necessary to optimize this intervention for the adolescent population. In this R34 proposal, we will use the Assessment-Decision-Administration-Production-Topic Experts-Integration-Training-Testing (ADAPT-ITT) framework-a systematic method for intervention adaptation- to adapt (Aim 1) and test the feasibility (Aim 2) of a treatment strategy for adolescents that has been shown to effectively link adults with OUD to ongoing addiction treatment.

Conditions

  • Opioid-use Disorder

Interventions

DRUG

ED-Initiated treatment with buprenorphine / naloxone

A Clinical Opiate Withdrawal Score (COWS) score will be administered, and an induction dose of buprenorphine when COWS scores \>=8. Participants who weigh \> 70 kg and/or reported using ≥ 3 bags of heroin/day or its prescription opioid equivalent will receive 4 mg. After 1 hour an additional 4 mg will be administered for a total of 8 mg. Participants who weigh \<= 70 kg and/or reported using ≤ 3 bags of heroin/day or its prescription opioid equivalent will receive 4 mg of buprenorphine. After 1 hour, an additional 2 mg will be administered for a total of 6 mg. Patients will be prescribed sufficient take-home daily doses (one-week supply) to ensure that the patient has adequate medication to receive 12-16 mg buprenorphine sublingual once daily. Parents of adolescents will also receive appropriate education on how to administer medication. Home induction instructions will be provided to patients and parents that arrive to the ED after an opioid overdose.

Sponsors & Collaborators

  • Yale University

    collaborator OTHER

  • University of Utah

    collaborator OTHER

  • University of California, Davis

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-30
Primary Completion
2025-07-30
Completion
2025-07-30
FDA Drug
Yes

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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 NCT04737603 on ClinicalTrials.gov