{"doi":"10.1177/02698811221149657","title":"A phase 1b study to investigate the potential interactions between ASP8062 and buprenorphine/naloxone in patients with opioid use disorder","abstract":"BACKGROUND: 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 γ-aminobutyric acid type B receptor under development for use with standard-of-care treatment for patients with OUD. AIMS: ). METHODS: 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 1-4; maintenance, Days 5-18; downward titration, Days 19-26; 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. RESULTS: = 6). With this sample size typical for phase 1 drug-drug 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. CONCLUSIONS: In this phase 1 study, ASP8062 was safe, well tolerated, and did not enhance respiratory suppression induced by buprenorphine. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT04447287.","journal":"Journal of Psychopharmacology","year":2023,"id":374207,"datarank":0.25029465965329345,"base_score":1.6094379124341003,"endowment":1.6094379124341003,"self_citation_contribution":0.24141568686511508,"citation_network_contribution":0.008878972788178348,"self_endowment_contribution":0.24141568686511508,"citer_contribution":0.008878972788178348,"corpus_percentile":null,"corpus_rank":null,"citation_count":4,"citer_count":3,"citers_with_citation_signal":2,"citers_with_endowment":2,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9243,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT04447287"]},"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1136197,"name":"Mark Walzer","orcid":null,"position":1,"is_corresponding":false},{"id":837247,"name":"Mary Beth Blauwet","orcid":"0000-0002-5719-7479","position":2,"is_corresponding":false},{"id":1136198,"name":"Anna Spence","orcid":null,"position":3,"is_corresponding":false},{"id":1136199,"name":"Nakyo Heo","orcid":null,"position":4,"is_corresponding":false},{"id":1136200,"name":"Debra Kelsh","orcid":null,"position":5,"is_corresponding":false},{"id":1136201,"name":"Paul Blahunka","orcid":null,"position":6,"is_corresponding":false},{"id":1136202,"name":"Jay Erdman","orcid":null,"position":7,"is_corresponding":false},{"id":1136203,"name":"Mohamad Nour Alsharif","orcid":null,"position":8,"is_corresponding":false},{"id":447111,"name":"Gerard J. Marek","orcid":"0000-0001-8103-4306","position":9,"is_corresponding":false},{"id":1135779,"name":"Mototsugu Ito","orcid":"0000-0003-2482-9019","position":0,"is_corresponding":true}],"reference_count":26,"raw_metadata":null,"created_at":"2026-07-19T01:16:11.341687Z","pmid":"36738100","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}