Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538558
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Study to Assess the Use of Tezampanel for Opioid Withdrawal Syndrome in Treatment-Seeking Patients With Opioid Use Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Single-Center Single-Blind Placebo-Controlled Dose-Escalation Study to Assess the Safety Pharmacokinetics and Efficacy of Tezampanel for Opioid Withdrawal Syndrome in Treatment-Seeking Patients With Opioid Use Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is examining the use of Tezampanel TZP for treatment of Opioid Withdrawal Syndrome OWS in participants with Opioid Use Disorder OUD Participants will receive TZP or placebo PBO daily on Days 2 - 7 during a 7-day inpatient stay at the research center to determine safety pharmacokinetic PK assessment and efficacy of TZP for OWS
Detailed Description:
This study is a phase I single-center single-blind dose escalation study conducted in four cohorts to characterize the safety tolerability PK profile and efficacy of TZP for mitigation of OWS in treatment-seeking participants Participants must be established in an outpatient treatment program and may be taking either long-acting opioid maintenance medications methadonebuprenorphine or short-acting opioids not yet converted to a long-acting maintenance medication
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None