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Medications for opioid use disorder (MOUD), such as methadone, buprenorphine, and extended-release naltrexone (XR-NTX), have been shown to reduce or eliminate opioid use and craving, protecting against opioid overdose and death. Stopping medication is associated with risk of relapse and potential overdose. Unsurprisingly, patients may desire to stop MOUD because of adverse effects, burden, or preference for recovery without medication, asking, “How long do I need to take medication?” Clinicians who treat OUD often encounter this uncomfortable risk-benefit discussion with patients who want to stop MOUD, hoping that the patients can do so successfully, while acknowledging the major risks. Prospective data are needed to inform those discussions. In designing one of the first clinical trials focused on MOUD discontinuation—the Discontinuation Phase of the Optimizing Retention, Duration, and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD) trial (NCT04464980)2—the investigators identified ethical issues that needed consideration in designing the study.
The authors of this Viewpoint are study investigators, including a social worker (S.E.P.) and 2 psychiatrists experienced with MOUD (R.D.W. and E.V.N.). In this Viewpoint, we describe those ethical challenges and our attendant solutions to inform the design of other studies of medication discontinuation, where discontinuing treatment could have grave consequences.
Related protocols: CTN-0100The mHealth revolution brings exciting possibilities for both researchers and clinicians, but the use of this technology also raises unique ethical concerns. The purpose of this talk is two-fold. First, we will be discussing some of the most pressing ethical challenges around mHealth. This will involve looking carefully at issues around data ownership, privacy, transparency, and consent. Second, we will introduce some possible solutions. Come discuss what researchers, clinicians, and institutions can do to address ethical risk.
Dr. Tiffany Cvrkel is a bioethicist, philosopher, and lecturer in UCLA’s Department of Molecular, Cell, & Developmental Biology. The primary focus of her work is categorizing the impact and limitations of deliberation as it occurs in the contexts of biomedical ethics. Her particular area of expertise is the ethics of emerging biomedical technologies, including the ethical challenges around mHealth, eHealth, and Big Data. In addition to being an award-winning teacher, she serves as a consultant to scientists and clinicians working with bioethical questions. She specializes in both bringing clarity to bioethical challenges and to assisting in the creation of practical solutions.
Additional Resources:
- Download slides (pdf)
This article discusses ethical challenges encountered in the design of an effectiveness trial (CTN-0051, X:BOT), comparing sublingual buprenorphine-naloxone (BUP-NX), an established treatment for opioid dependence, to the newer extended-release injectable naltrexone (XR-NTX). Ethical issues surrounded:
1) Known poor effectiveness of one possible, commonly used Treatment as Usual control condition — detoxification followed by counseling without medication;
2) The role of patients’ preferences for treatments, given that treatments were clinically approved and available to the population;
3) Differences between the optimal “usual treatment” clinical settings for different treatments making it challenging to design a fair comparison;
4) Vested interest groups favoring different treatments exerting potential influence on the design process;
5) Potentially vulnerable populations of substance users and prisoners;
6) Potential therapeutic misconception in the implementation of safety procedures; and
7) High cost of a large trial limited questions that could be addressed.
The authors examine how the design features underlying these ethical issues are characteristic of effectiveness trials, which are often large trials that compare treatments with varying degrees of existing effectiveness data and familiarity to patients and clinicians, in community-based treatment settings, with minimal exclusion criteria that could involve vulnerable populations. Hence, investigators designing effectiveness trials may wish to remain alert to the possibility of similar ethical issues.
Related protocols: CTN-0051
Good Clinical Practice guidelines provide ethical and scientific standards for the design, quality assurance, data collection, analyses, and reporting for clinical trials. GCP standards ensure that research staff protect the rights, safety, well-being, and confidentiality of trial participants as well as comply with best practices in their conduct of clinical investigations.
This 90-minute presentation focused on the critical aspects of ICH GCP Principles and the Code of Federal Regulations (CFR) for clinical research trials. Presenters Denise King, MS and Lauren Yesko, both of The Emmes Corporation, also discussed Good Clinical Practice (GCP) and Good Clinical Data Management Practice (GCDMP) trends in the National Drug Abuse Treatment Clinical Trials Network (CTN).
Learning objectives included:
- Review principles and regulatory requirements for GCP.
- Discuss staff roles and responsibilities, protocol compliance, and other criteria for conducting quality trials.
- Examine best practices, examples of GCP non-compliance, and corrective actions for protocol or procedural deviations.
- Identify significant GCP/GCDMP trends in the CTN, such as informed consent, safety, documentation, drug management, and data management.
Additional Resources:
- Download slides (pdf)
- Download handout (pdf)
This presentation, part of a panel at the Society for Clinical Trials annual meeting in 2012 focusing on ethical, regulatory, recruitment issues in vulnerable populations, covers the basic definitions and guidelines for including participants who are considered “prisoners” in substance abuse treatment research. In order to conduct research with prisoners, there are several additional, potentially complex steps that must be undertaken with the researchers’ institutional review board of record. Used as a practical example, National Drug Abuse Treatment Clinical Trials Network protocol CTN-0044, “Web-Delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders,” is discussed, as approximately 35% of participants at baseline were either mandated or referred for treatment by the criminal justice system (a handful even wearing monitoring bracelets). In any trial, regardless of whether you have approval to conduct research with prisoners, the study must have procedures in place to determine if a participant is indeed a prisoner. Though this can be straightfoward if the participant is in a detention facility, there are a small number of cases where participants reside in the community but are considered a prisoner under the definition of the Office of Human Research Protections (OHRP). For CTN-0044, this mean the development of a screening procedure that asked a simple question about house arrest and followed-up with additional probes if necessary (for participants in this protocol, even those wearing ankle monitors were not officially considered “prisoners” because while their movements were restricted, they were allowed to come and go of their own accord to the treatment facility). The presentation provides an in-depth look at the issues surrounding research with prisoners, including the importance of including individuals who become incarcerated during a study to reduce bias.
Related protocols: CTN-0044
This 2-hour webinar, produced by the National Drug Abuse Treatment Clinical Trials Network (CTN) Clinical Coordinating Center for CTN members and the public, discusses the ethical principles underlying the conduct of research and Good Clinical Practices (GCP) within the CTN. Participants will receive an overview of GCP knowledge and practical examples of research site challenges.
This webinar is intended for CTN members and the public, especially research staff seeking a GCP refresher course and novice research staff responsible for conducting clinical trials.
Presented by Ron Jackson, MSW (Evergreen Treatment Services, PN Node) and Charlotte Royer-Malvestuto, MEd, MBE (University of Pennsylvania, DV Node).
Additional Resources:
- Download slides (pdf)
This one-hour webinar, produced by the National Drug Abuse Treatment Clinical Trials Network (CTN) Clinical Coordinating Center for CTN members and the public, is intended to assist CTN affiliated research staff understand the principles that govern human subject research and the importance of informed consent in research trials.
The target audience includes CTN members and members of the public interested in learning more about the process, principles, and requirements involved in working with human subjects in clinical trials.
Presented by Lynn Kunkel, MS, CCRP (Oregon Health & Science University, WS Node) and Jennifer Sharpe Potter, PhD (University of Texas, TX Node).
Additional Resources:
- Download slides (pdf)