Drs. Thomas Blue and Michael Gordon Receive R01 Award
FRI is pleased to announce that Drs. Thomas Blue and Michael Gordon (MPIs), have received a five-year R01 grant from the National Institute on Drug Abuse entitled, “A comparative effectiveness trial of sublingual versus extended-release buprenorphine with individuals leaving a carceral setting.” The Co-investigators include Drs. Frank Vocci (FRI), Sean Murphy and Ali Jalali (Weill Cornell Medical College), Danielle Rudes (Sam Houston State University and The Center for Advancing Correctional Excellence at George Mason University), and Marc Fishman (Maryland Treatment Center). This study builds on the investigators’ experience conducting clinical trials using both extended-release buprenorphine (XR-B) and sublingual-buprenorphine-naloxone (SL-B) with individuals in jails and prisons. An open-label design will randomly assign 240 adults with Opioid Use Disorders (OUDs)who are soon-to-be-released from a large metropolitan jail to either XR-B (n = 120) or SL-B (n = 120) treatment in jail followed by 6-months of post-release buprenorphine treatment, a 7-month safety visit, and a final long-term follow-up at 12-months. The study has three aims. Aim 1. Compare the effectiveness of XR-B vs. SL-B in terms of: (a) illicit opioid use, (b) retention in buprenorphine treatment, (c) other illicit substance use, (d) overdose events, (e) quality of life, (f) HIV risk behaviors; and (g) criminal activity. Aim 2. To calculate the cost to the state and/or jail/city health system of implementing XR-B and SL-B, and determine the relative value, including the costs associated with the interventions in the community, from a county and state-policymaker and societal perspective. Aim 3. Explore barriers and facilitators to implementation of XR-B versus SL-B in jail with regards to the following: (1) staff perceptions and understanding of medications for OUD (MOUDs) programs, goals, and delivery; (2) dose induction; (3) diversion and procedures for reducing diversion; (4) continuity of care after release or transfer to another facility; (5) staffing (both custody and medical) needs for daily versus XR-B dosing; and (6) patient preference for XR-B versus SL-B. The study will be innovative because it would be the first large scale RCT in the U.S. assessing effectiveness and cost effectiveness of XR-B versus SL-B with individuals in a jail who are re-entering the community. The study will be highly significant because most individuals in the US with an OUD do not receive treatment while in jail, thereby substantially raising their likelihood of relapse to drug use, overdose death, and re-incarceration when they are released. Finally, understanding how to expand acceptance of MOUDs in jails has far-reaching implications for treatment access in this population.