NCT04737603|WithdrawnPhase 2DMCFDA Drug
Study Stopped
This study was not funded and therefore not recruiting. So we never opened the study.
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This study was not funded and therefore not recruiting. So we never opened the study.
PEDsTREATOUD
Sponsor study identifier
interventional
0
0 countries
N/A
Study Start
July 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 22, 2021
Actual (reported)February 4, 2021
Actual (reported)July 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
ED-Initiated treatment with buprenorphine / naloxone
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record0 participants (actual enrollment reported by the registry).
First Submitted
January 22, 2021
First Posted
February 4, 2021
Study Start
July 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Extended-release Buprenorphine as a Novel Low-dose Induction Strategy
Inpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder
Contact the study team to confirm eligibility.
Primary Completion
July 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 12, 2024
Record last verified: 2024-11
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Source: ClinicalTrials.gov.
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