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CTN-0109: Randomized, Placebo-Controlled Trial of Injectable Naltrexone and Monthly Injectable Buprenorphine for Cocaine Use Disorder (CURB-2)
Both Rush University and University of Chicago will participate as sites in this study. Cocaine is one of the most commonly abused stimulants globally, and in the US, there are signs of a resurgence of cocaine use. A variety of pharmacotherapies for cocaine use disorder (CUD) has been explored but so far, no study has findings robust enough to warrant FDA approval. Recent research suggests that a kappa opioid receptor antagonist can curb the negative emotional states associated with stimulant withdrawal that leads to increased craving and drug-seeking behaviors. This protocol builds up on results of the Cocaine Use Reduction with Buprenorphine (CURB) study. It aims to evaluate the safety and efficacy of combined monthly injections of XR-NTX and injectable BUP for CUD compared to placebo.
CTN-0111: COVID-19 and Substance Misuse Case Identification using Data Science: A Retrospective Cohort Study
This project will provide novel and critically important tools in artificial intelligence for the detection of substance misuse and COVID-19 from the electronic health record (EHR). Development and validation of a digital classifier would enable a standardized approach to perform screening on all patient encounters on a daily basis in health systems. We will rigorously develop and test the classifier retrospectively on an existing dataset of 60,000 patients who have been screened for COVID-19. This will serve as the first step towards a comprehensive universal screener that leverages available data in the EHR.
CTN-0128: Adherence and Feasibility of Wearable Technologies and Ecological Momentary Assessment to Assess Autonomic Function and Negative Affect in Opioid Use Disorder
Negative Affect (NA) and stress are key features of Opioid Use Disorder (OUD) and often lead to drug use and relapse. The Autonomic Nervous System (ANS) dominates physiological responses to emotions and stress, yet its function and how it unfolds over time and in real-world settings remains understudied in the context of OUD. With new wearable technologies, ANS function can be measured through heart rate variability (HRV) and can be recorded continuously via wearable sensors, providing a non-invasive method to examine physiological mechanisms underlying stress and NA in real-world settings and in real-time. The present research will serve as a pilot study to assess 1. The role of autonomic function (indexed by HRV) as a marker of NA and stress in people with OUD 2. Participants’ adherence to wearing sensor devices and response rates to daily questionnaires. To achieve these objectives, we will monitor participants for 14 days and quantify self-reports measures of stress, overall daytime HRV patterns, and the magnitude, frequency, and duration of reduced HRV instances. Our findings can help advance technologies to address the opioid epidemic, and our understanding of physiological markers as objective measures and predictors of NA and stress in OUD.
CTN-0130: Quantifying How Cocaine Users Respond to Fentanyl Contamination in Cocaine
The increased presence of fentanyl in cocaine has drastically increased cocaine-related overdoses, yet there is no research quantifying how cocaine users respond to fentanyl adulteration. In this online study, a modification of a behavioral economics measure, the Cocaine Purchase Task, will quantify for the first time how cocaine users respond to fentanyl contamination in cocaine. This study aims to 1) Determine how possible fentanyl adulteration affects cocaine demand, and 2) Determine which individual characteristics moderate the relationship between fentanyl adulteration and cocaine demand. Determining how possible fentanyl adulteration affects cocaine demand can help inform the development of effective harm reduction interventions for people who use cocaine to address the worsening crisis of opioid related deaths.
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