{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T01:31:59Z","timestamp":1777858319982,"version":"3.51.4"},"reference-count":35,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2023,2,1]],"date-time":"2023-02-01T00:00:00Z","timestamp":1675209600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UG3DA051392"],"award-info":[{"award-number":["UG3DA051392"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Psychopharmacol"],"published-print":{"date-parts":[[2023,2]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>There is an unmet need for therapeutics with greater efficacy and tolerability for the treatment of opioid use disorder (OUD). ASP8062 is a novel compound with positive allosteric modulator activity on the \u03b3-aminobutyric acid type B receptor under development for use with standard-of-care treatment for patients with OUD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aims:<\/jats:title>\n                    <jats:p>\n                      To investigate the safety, tolerability, interaction potential, and pharmacokinetics (PK) of ASP8062 in combination with buprenorphine\/naloxone (B\/N; Suboxone\n                      <jats:sup>\u00ae<\/jats:sup>\n                      ).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>In this phase 1, randomized, double-masked, placebo-controlled study, patients with OUD began B\/N (titrated to 16\/4 mg\/day) treatment upon enrollment (induction, Days 1\u20134; maintenance, Days 5\u201318; downward titration, Days 19\u201326; and discharge, Day 27). On Day 12, patients received a single dose of ASP8062 60 mg or placebo with B\/N and underwent safety and PK assessments. Primary endpoints included frequency and severity of treatment-emergent adverse events (TEAEs), clinical laboratory tests, respiratory depression, and suicidal ideation. Secondary endpoints investigated the impact of ASP8062 on B\/N PK.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Eighteen patients were randomized and completed the study (ASP8062,\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      = 12; placebo,\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      = 6). With this sample size typical for phase 1 drug\u2013drug interaction studies, ASP8062 was well tolerated; most TEAEs were mild in severity, and none led to treatment withdrawal. ASP8062 did not enhance substance use-related TEAEs, respiratory depression, or suicidal ideation and did not have a clinically significant impact on the PK of B\/N.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>In this phase 1 study, ASP8062 was safe, well tolerated, and did not enhance respiratory suppression induced by buprenorphine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration:<\/jats:title>\n                    <jats:p>Clinicaltrials.gov identifier: NCT04447287.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/02698811221149657","type":"journal-article","created":{"date-parts":[[2023,2,4]],"date-time":"2023-02-04T01:22:25Z","timestamp":1675473745000},"page":"144-154","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":3,"title":["A phase 1b study to investigate the potential interactions between ASP8062 and buprenorphine\/naloxone in patients with opioid use disorder"],"prefix":"10.1177","volume":"37","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2482-9019","authenticated-orcid":false,"given":"Mototsugu","family":"Ito","sequence":"first","affiliation":[{"name":"Development Project Management, Astellas Pharma Global Development, Inc., Northbrook, IL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark","family":"Walzer","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Exploratory Development, Astellas Pharma Global Development, Inc., Northbrook, IL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mary","family":"Beth Blauwet","sequence":"additional","affiliation":[{"name":"Biostatistics Department, Astellas Pharma Global Development, Inc., Northbrook, IL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna","family":"Spence","sequence":"additional","affiliation":[{"name":"Biostatistics Department, Astellas Pharma Global Development, Inc., Northbrook, IL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nakyo","family":"Heo","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Exploratory Development, Astellas Pharma Global Development, Inc., Northbrook, IL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Debra","family":"Kelsh","sequence":"additional","affiliation":[{"name":"Altasciences Clinical Kansas, Inc., Overland Park, KS, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul","family":"Blahunka","sequence":"additional","affiliation":[{"name":"Employee of Astellas at the time of the study"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jay","family":"Erdman","sequence":"additional","affiliation":[{"name":"Medical Specialties, Astellas Pharma Global Development, Inc., Northbrook, IL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mohamad","family":"Nour Alsharif","sequence":"additional","affiliation":[{"name":"Medical Specialties, Astellas Pharma Global Development, Inc., Northbrook, IL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gerard J","family":"Marek","sequence":"additional","affiliation":[{"name":"Employee of Astellas at the time of the study"},{"name":"Gilgamesh Pharmaceuticals, Inc., New York, NY, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2023,2,3]]},"reference":[{"key":"e_1_3_3_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/npp.2017.53"},{"key":"e_1_3_3_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(18)33078-2"},{"key":"e_1_3_3_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.drugalcdep.2021.108967"},{"key":"e_1_3_3_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.drugalcdep.2021.109057"},{"key":"e_1_3_3_6_1","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-200427110-00004"},{"key":"e_1_3_3_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.npp.1300088"},{"key":"e_1_3_3_8_1","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kwx321"},{"key":"e_1_3_3_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejphar.2007.05.069"},{"key":"e_1_3_3_10_1","doi-asserted-by":"publisher","DOI":"10.3109\/03639045.2013.846365"},{"key":"e_1_3_3_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.drugalcdep.2009.02.014"},{"key":"e_1_3_3_12_1","first-page":"43","article-title":"The opioid crisis: Prevalence and markets of opioids","volume":"34","author":"Gardner E","year":"2022","unstructured":"Gardner E, McGrath S, Dowling G, et al. 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