Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 12:12 AM
NCT ID:
NCT06538558
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, methadone/buprenorphine, or short-acting opioids (not yet converted to a long-acting maintenance medication).
Study:
NCT06538558
Study Brief:
Protocol Section:
NCT06538558