Feasibility of Pediatric Emergency Department-Initiated Treatment for Adolescents With Opioid Use… (NCT04737603) | Clinical Trial Compass
WithdrawnPhase 2
Feasibility of Pediatric Emergency Department-Initiated Treatment for Adolescents With Opioid Use Disorder
Stopped: This study was not funded and therefore not recruiting. So we never opened the study.
0Started 2025-07-30
Plain-language 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.
Who can participate
Age range
13 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 13 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
Exclusion criteria
. Have a urine toxicology test positive for methadone;
. Unable to provide consent due to critical illness or reduced capacity
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with treatment engagement
Timeframe: 30 days
2
Mean number of days of self-reported opioid use as assessed by Timeline Follow-Back (TLFB)
Timeframe: 30 days
3
% of urine samples testing negative for opioid use