News from the Ohio Valley Node

CTN-0150 (TOME) study is completed!

The CTN-OVN has successfully completed the CTN-0150 (TOME; LI – Winhusen) study activities and is now heading into data analysis.  This study was part of the supplemental IMPROVE funds from NIDA and the NICHD awarded to the OVN to utilize the CTN-0080 study as a platform to collect additional data regarding Opioid Use Disorder in pregnant/postpartum populations.  TOME included two objectives:  1) to evaluate the ability of the Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME) intervention to increase MOUD and opioid-overdose knowledge in pregnant and postpartum (PP) persons (Primary), and 2) to evaluate the ability of TOME to decrease MOUD-related internalized stigma and expected difficulty in avoiding drug use (Secondary). Six of the 13 MOMs sites participated and enrolled 131 participants (goal:  120).  Congratulations and thank you to the TOME sites!

Two new studies in development!

The CTN-OVN has recently been approved to move forward with two new studies, both of which will be funded by the NIH HEAL Initiative:

CTN-0152: Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the treatment of opioid use disorder: A pragmatic, multi-site, double-blind, Randomized, placebo-controlled, trial (TAB; LI – Winhusen) will test tirzepatide, which is a GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) agonist, as an adjunct to buprenorphine for the treatment of opioid use disorder.  It is anticipated that 12 sites will recruit approximately 310 participants into this 30-week study.  The study is currently in the process of site selection, with a goal of starting recruitment in September 2025.

CTN0153: Effects of Semaglutide and Tirzepatide on Incidence and Outcomes of Stimulant Use Disorders (StUD) and Opioid Use Disorder (OUD) in Real-world Populations: Target Trial Emulation Using Patient Electronic Health Records (GLP-SUD; Co-LIs Xu and Winhusen) will entail conducting emulation target trials utilizing a nationwide electronic health records (EHR) database of over 118 million US patients including 945,000 patients with OUD, and 842,000 with StUDs including 470,000 with methamphetamine use disorder. By emulating clinical trials using a large EHR database, this study will provide clinical evidence gathered from real-world patient populations to support prospective randomized-controlled trials in testing the effectiveness of semaglutide and tirzepatide for treating StUD and OUD.  The study is currently in protocol development.