Abstract ID: 1111

Primary Topic: Mind-body (including meditation and yoga)
Secondary Topic: Research Methodology

An ongoing RCT in an urban methadone clinic: lessons learned and the road ahead
Zofia Kozak, MD Candidate ; Annabelle Belcher, PhD; Luana Colloca, MD, PhD; Christopher Welsh, MD, , Baltimore, MD, United States

Category: Clinical

Late Breaker: No

Overview

Methadone (MTD), a full mu-receptor opioid agonist, is a commonly prescribed medication for Opioid Use Disorder. A physician works closely with patients to prescribe a dose that manages withdrawal symptoms and craving, which are self-reported by the patient. The placebo effect reduces symptom severity in a variety of diseases, and may extend the therapeutic index of pain analgesics via a placebo dose-extension (PDE) paradigm. This RCT, conducted in a West Baltimore city methadone clinic, examines the potential role of open-label placebo administered within a PDE paradigm.

Conducting this study in a high-volume, inner-city methadone clinic presented several unique challenges. One notable difficulty was integrating the study protocol into an already-congested clinic workflow. Patients were approached to participate in the study on their first day of treatment, when they typically have 4-6 hours of intake procedures with a variety of clinic personnel, from therapists to payment counselors. Fitting the RCT study measurements into an already non-linear intake process proved to be a primary challenge. Other challenges included completing intake procedures/study questionnaires while participants were experiencing acute opioid withdrawal (i.e prior to dosing), and maintaining participant contact and follow-up, most of whom were housing unstable.

These challenges are redeemed by the invaluable insights this study provides into the pulse of Baltimore's opioid epidemic. In this community-based setting, all participants were enrolled in a local MTD treatment program and recruited directly from this ground source. In contrast, a RCT conducted in a traditional research setting recruits outside patients to participate in the specific research trial, and often has infrastructure set up to facilitate the clinical protocol. The demographics of such participants and this specific infrastructure makes the study less susceptible to the challenges described above; however, this may be at the expense of obtaining a representative cross-section of the target population being studied

Rationale

Drug use is endemic throughout the United States, and increasing amounts of research dollars are spent investigating interventions to stem this public health emergency. Addiction is a complex phenomenon to study, as there are a wide range of factors thought to contribute to its onset and progression. Research settings that closely resemble the natural environment of those affected by the disease may be able to provide the most accurate and representative insights. However, conducting such RCTs comes with unique challenges. Having studied addiction both in a clinical setting (such as this) and research setting with the National Institute on Drug Abuse (NIDA), the presenting author (Zofia Kozak, MSII at University of Maryland, School of Medicine), will discuss the challenges and benefits of conducting addiction research in a community clinical setting.

Objectives

1) Learn about unique challenges faced by a RCT studying addiction within an urban, community methadone clinic  

2) Discuss the benefits of conducting clinical research, particularly studying addiction, in a setting that is interwoven with participants' typical daily routine (i.e within the walls of a community methadone clinic, vs. a research setting). 

3) Learn about how the placebo response, which involves mind/body interactions, may be ethically harnessed in clinical practice and about its potential in improving outcomes in methadone-maintained patients.