GLP-1 Outcomes with people Using Psychoactive Substances (GLOW-UPS): a multi-stage, multi-site trial among persons involved in the criminal-legal system
Funded under the Justice Community Opioid Innovation Network (JCOIN) 2.0 initiative, GLOW-UPS is a collaboration between investigators at New York University, Friends Research Institute, Dartmouth University, and Yale University, focused on glucagon-like peptide-1 receptor agonist (GLP-1) medications and their potential utility for addressing substance use disorders (SUD) among individuals involved in the criminal-legal system.
As GLP-1 for SUD indications and GLP-1 research in correctional systems represents early stage research, this project will proceed using a multi-stage approach.
The first stage is a mixed-methods Feasibility/Acceptability study focused on protocol development through qualitative and quantitative data gathering. Stage1 includes surveys and qualitative interviews with incarcerated persons, persons with lived experience, and department of correction (DOC) health providers and leadership surrounding interest, adoption and optimal protocols for GLP-1 for currently approved indications (DM2/overweight/obesity/other) and substance use disorder (SUD). Open questions include prevalence of medical conditions for which GLP is approved and co-occurring SUD among incarcerated individuals, correctional health and security delivery capacities, drug costs and GLP-1 formulations in corrections, transitional care models and pre- vs. post-release GLP-1 initiation, telehealth supports, self- vs. in-clinic administration, and tolerability and side effects.
This research will inform the second Stage of the study, a delayed onset effectiveness-implementation randomized clinical trial of GLP-1, tentatively among pre-release adults (age 18 and older) with DSM-5 SUD (opioid, stimulant, alcohol, nicotine, cannabis, in a to be determined combination), followed post-release for SUD outcomes (to be determined: cravings, overdose, treatment retention, return to use) and medical outcomes (weight, glucose control).
Aim 1. Stage1 is a mixed methods protocol development phase assessing the feasibility, and acceptability of GLP-1s for both approved medical conditions and co-occurring SUD in a correctional clinical trial, informed by Proctor’s model of implementation outcomes. Stage1 Milestones proposed for proceeding to the Stage 2 clinical trial are: 1) DOC systems mapping for GLP-1 indications, SUD prevalence and current GLP-1 protocols, and site selection, 2) participant-level survey data collection, 3) qualitative data collection from key informants and focus groups, and, 4) expert advisory board and Sponsor consensus on clinical trial design choices (inclusion/exclusion, SUD mix, primary outcome).
Aim 2. Stage2 multi-site hybrid type 1 effectiveness-implementation randomized trial of GLP-1 vs. no GLP-1 for current indicated use (DM2, overweight, other) among persons with candidate SUDs (OUD, AUD, Stimulant, nicotine/tobacco, and/or cannabis) measuring SUD outcomes (cravings, use, treatment retention, overdose). While GLP-1 effectiveness as SUD treatment is anticipated as the Aim 2 primary outcome, Stage1 synthesis and consensus will determine precise eligibility criteria, which SUDs to target and in what combination, a valid and clinically relevant primary outcome, and final sample size.
Aim 3. Stage2 implementation outcomes from and during the clinical trial will be informed by the RE-AIM evaluation framework and Proctor model of implementation outcomes, including organizational and participant-level experiences and feedback regarding GLP-1 implementation, costs, and interactions with standard SUD treatments.