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Ethical and Clinical Safety Considerations in the Design of an Effectiveness Trial: A Comparison of Buprenorphine Versus Naltrexone Treatment for Opioid Dependence.

Contemporary Clinical Trials 2016;51:34-43. [doi: 10.1016/j.cct.2016.09.006]

Edward V. Nunes, MD (Columbia University, GNY Node), Joshua D. Lee, MD, MSc (New York University School of Medicine, GNY Node), Dominic Sisti, PhD (Perelman School of Medicine), Andrea Segal, MS (Perelman School of Medicine), Arthur Caplan, PhD (New York University School of Medicine, GNY Node), Marc J. Fishman, MD (Johns Hopkins University School of Medicine, MA Node), Genie L. Bailey, MD (Stanley Street Treatment & Resources, NEC Node), Gregory S. Brigham, PhD (Adapt, WS Node), Patricia Novo, MPA, MPH (New York University School of Medicine, GNY Node), Sarah Farkas, MA (New York University School of Medicine, GNY Node), John Rotrosen, MD (New York University School of Medicine, GNY Node).

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. (Article (Peer-Reviewed), PDF, English, 2016)

Keywords: Buprenorphine/Naloxone | CTN protocol development | Ethics | Heroin | Naltrexone | Pharmacological therapy | Prescription-type opiates | Research design | Contemporary Clinical Trials (journal)

Document No: 1230, PMID: 27687743, PMCID: PMC5466164.

Submitted by CTN Dissemination Librarians, 10/7/2016.

Bailey, Genie L. mail
Brigham, Gregory S. search mail
Caplan, Arthur
Farkas, Sarah mail
Fishman, Marc J. mail
Lee, Joshua D. search mail
Novo, Patricia mail
Nunes, Edward V. mail
Rotrosen, John search mail
Segal, Andrea search
Sisti, Dominic search
NIDA-CTN-0051 www
Greater New York (Lead) www
Mid-Atlantic www
Florida Node Alliance www
New England Consortium www
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