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

NCT04737603 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 1707330
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Buprenorphine; Adolescents; Pediatrics; Emergency Department

Outcome Measures

Primary Outcomes (3)

• Number of participants with treatment engagement

  Number of enrolled participants who 1) provide written consent for treatment status verification, 2) provide a urine toxicology sample. Reasons for not providing consent/toxicology sample will be recorded.

  30 days

• Mean number of days of self-reported opioid use as assessed by Timeline Follow-Back (TLFB)

  Timeline Follow-Back (TLFB): The TLFB procedure will be used to elicit the patient participant's self- reported use, quantity, and route of administration of opioids, alcohol, tobacco, marijuana, stimulants, and benzodiazepines over the previous 7 days. The validity of adolescent self-report data on substance use and TLFB has been documented previously in the literature.

  30 days

• % of urine samples testing negative for opioid use

  Patients will provide a urine sample at 30 days and will be tested for the presence of opioids.

  30 days

Study Arms (1)

ED-initiated treatment with buprenorphine/naloxone.

EXPERIMENTAL

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.

Drug: ED-Initiated treatment with buprenorphine / naloxone

Interventions

ED-Initiated treatment with buprenorphine / naloxone DRUG

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.

Also known as: Suboxone

ED-initiated treatment with buprenorphine/naloxone.

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• years-old up to their 18th birthday on day of enrollment
• Meet DSM-5 criteria for moderate/severe opioid use disorder;
• Have a urine toxicology test positive for opioids, oxycodone, or buprenorphine (non-prescribed by history)
• Can provide information for 2 reliable contacts that the study staff can contact in the case the study participant cannot be reached

You may not qualify if:

• Have a urine toxicology test positive for methadone;
• Unable to provide consent due to critical illness or reduced capacity
• In jail/prison or in police custody;
• Under the guardianship of child protective services;
• Requires opioid medications for a currently present chronic pain condition;
• Transferred from the ED to an inpatient unit prior to being able to provide consent;
• Already enrolled in formal OUD treatment with medications with intent to return to the treatment program after ED discharge; or
• Previously enrolled in the current study

Sponsors & Collaborators

• University of California, Davis: lead
• Yale University: collaborator
• University of Utah: collaborator

MeSH Terms

Conditions

Opioid-Related Disorders; Emergencies

Interventions

Buprenorphine; Naloxone; Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: February 4, 2021
• Study Start: July 30, 2025
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-11