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NCT04794790
Buprenorphine Induction for Fentanyl Dependent Opioid Users
EARLY_PHASE1 trial testing Buprenorphine/naloxone in Opioid Dependence Fentanyl. Withdrawn.
22 February 2024
Quick facts
| Lead sponsor | Milton S. Hershey Medical Center |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Start date | 9 May 2022 |
| Primary completion | 22 February 2024 |
| Estimated completion | 22 June 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Buprenorphine/naloxone
Conditions studied
- Opioid Dependence Fentanyl — all drugs for Opioid Dependence Fentanyl →
Sponsor
Milton S. Hershey Medical Center
Who can join
Adults 18 to 99, any sex, with Opioid Dependence Fentanyl. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The overall goal of this pilot study is to characterize illicit fentanyl and combination fentanyl and opioid dependence explicitly, by assessing physiologic barriers to effective buprenorphine induction. Results from this pilot study may make a case for a larger feasibility study to be conducted through the Clinical Trials Network at the National Institutes of Drug Abuse. The primary hypothesis is that individuals dependent on illicit fentanyl and combination fentanyl and opioids will have difficulty with standard buprenorphine induction, and will need a modified approach. The primary outcome measure will be retention on buprenorphine at seven days post induction. The secondary outcome measures will be objective precipitated withdrawal and the rate of patients requiring or requesting to initiate methadone due to intolerance of buprenorphine.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04794790
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other trials of Buprenorphine/naloxone
Trials testing the same drug.
- NCT05011266 — Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder · Phase 2, PHASE3 · recruiting
- NCT04480554 — Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1 · Phase 2 · terminated
- NCT05307458 — Evaluating the Pharmacokinetics and Patient Outcomes of Buprenorphine Microdosing · unknown
- NCT03580902 — CBT4CBT for Office Based Buprenorphine · Phase 1, PHASE2 · completed
- NCT03740243 — Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology · Phase 4 · withdrawn
Other Milton S. Hershey Medical Center trials
Trials by the same sponsor.
- NCT05180552 — The HEALiX: Comparing the Efficacy of the HEALiX Device With Wrist Restraints in a Critical Care Setting · NA · withdrawn
- NCT07461844 — Transdiagnostic Sleep and Circadian Treatment for Autistic Adults · NA · not yet recruiting
- NCT06253858 — Ultrasound (US) Guided External Ventricular Catheter Placement · NA · not yet recruiting
- NCT07225699 — IN PATIENTS WITH CORNEAL ABRASIONS TREATED WITH COLLAGEN CORNEAL SHIELDS IN THE EMERGENCY DEPARTMENT SETTING · NA · not yet recruiting
- NCT07461168 — Penn State Emergency Medicine CarES: Care-partner Evaluation and Sourcing in the Emergency Department · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04794790 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Milton S. Hershey Medical Center
- Last refreshed: 22 May 2024
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/NCT04794790.
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