Reducing the Impact of Opioid Use Disorder on the Acquisition and Management of HIV and on Comorbidities (SEARCH)
Document text
Principal Investigator: Henry Masur Organization: CLINICAL CENTER Fiscal Year: 2024 Funding agency: NIH Clinical Center 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 There is no date set for when such a molecule will be available for human trials There are long term follow up studies of patient outcome that are being done Terms: <AIDS><AIDS Virus><Acquired Immune Deficiency><Acquired Immune Deficiency Syndrome><Acquired Immune Deficiency Syndrome Virus><Acquired Immunodeficiency Syndrome><Acquired Immunodeficiency Syndrome Virus><Adanon><Affect><Althose><Aminotransferases><Behavior><Blood><Blood Reticuloendothelial System><COVID-19 outbreak><COVID19 outbreak><Collaborations><Consultations><Cytochrome P-450><Cytochrome P-450 Enzyme System><Cytochrome P450><Cytochrome P450 Family Gene><Development><Dolophine><Dopamine><Drugs><Enrollment><Follow-Up Studies><Followup Studies><Goals><HCV/HIV><HIV><HIV and HCV><HIV and hepatitis C><HIV-HCV><HIV/HCV><HIV/Hepatitis C><Hepatotoxic effect><Hepatotoxicity><Human><Human Immunodeficiency Viruses><Hydroxytyramine><Individual><Intermediary Metabolism><Investigators><LAV-HTLV-III><Liver Toxicity><Long-term Follow-up><Longterm Follow-up><Lymphadenopathy-Associated Virus><Medication><Metabolic Processes><Metabolism><Methadone><Methadose><Midazolam><Modern Man><NIAAA><NIAID><NIDA><NIH><NIMH><NINDS><National Institute of Allergy and Infectious Disease><National Institute of Drug Abuse><National Institute of Mental Health><National Institute of Neurological Diseases and Stroke><National Institute of Neurological Disorders and Stroke><National Institute on Alcohol Abuse and Alcoholism><National Institute on Drug Abuse><National Institutes of Health><Needle Sharing><P450><Pathway interactions><Patient outcome><Patient-Centered Outcomes><Patient-Focused Outcomes><Pharmaceutical Preparations><Phase><Phase I Study><Research Personnel><Researchers><Respiratory Depression><SARS-CoV-2 outbreak><Severe acute respiratory syndrome coronavirus 2 outbreak><Stimulus><Substance Use Disorder><Substance of Abuse><Syringe Sharing><Toxic effect><Toxic effect on liver cells><Toxicities><Transaminases><Transmission><United States National Institutes of Health><Ventilatory Depression><Virus-HIV><Washington><Woman><alcohol use disorder><clinical center><co-morbid><co-morbidity><comorbidity><consultation><coronavirus disease 2019 outbreak><coronavirus disease-19 outbreak><craving><depressed breathing><depression of breathing><design><designing><developmental><drug/agent><enroll><ethanol use disorder><hepatic toxicity><hepatoxicity><high risk behavior><inhibitor><long-term followup><longterm followup><novel><opiate use disorder><opioid use disorder><outbreak of SARS-CoV-2><pathogen><pathway><patient oriented outcomes><phase 1 study><phase 2 study><phase II study><substance use and disorder><substances of abuse><transmission process><volunteer>