Reducing the Impact of Opioid Use Disorder on the Acquisition and Management of HIV and on Comorbidities (SEARCH)

Clinical Center

Investigators

Abstract

The project is led by DCPFAP investigators with the active collaboration of NIMH, NIDA, NINDS, and NIAID. For the first study, a phase I study carried out at the NIH Clinical Center, investigators met with FDA to determine what studies needed to be done prior to a Phase II study. An interaction study between ANS 6697 and midazolam was indicated to determine whether cytochrome p450 metabolism was affected by ANS 6697. Twelve normal volunteers were enrolled, No interaction was detected. No effect on circulating dopamine metabolism was detected which was the anticipated result in individuals who had no substance use disorder and no stimulus for cravings. The initiation of phase II was altered due to the COVID outbreak, an FDA request that an interaction study between methadone and ANS 6697 be done to assess respiratory depression, and an FDA hold to assess transaminase elevations in women who were receiving the drug in an NIAAA study of alcohol use disorder.The development of this compound has been terminated due to the hepatotoxicity, after consultation with FDA. The project will resume if the sponsor can develop a molecule targetting the same pathway that is not associated with similar toxicity There is no progress on this until a new molecule becomes available for human trials