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Causality and PsychopathologyFinding the Determinants of Disorders and their Cures$
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Patrick Shrout, Katherine Keyes, and Katherine Ornstein

Print publication date: 2011

Print ISBN-13: 9780199754649

Published to Oxford Scholarship Online: November 2020

DOI: 10.1093/oso/9780199754649.001.0001

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Statistical Methodology for a SMART Design in the Development of Adaptive Treatment Strategies

Statistical Methodology for a SMART Design in the Development of Adaptive Treatment Strategies

8 Statistical Methodology for a SMART Design in the Development of Adaptive Treatment Strategies
Causality and Psychopathology

Alena I. Oetting

Janet A Levy

Oxford University Press

The past two decades have brought new pharmacotherapies as well as behavioral therapies to the field of drug-addiction treatment (Carroll & Onken, 2005; Carroll, 2005; Ling & Smith, 2002; Fiellin, Kleber, Trumble-Hejduk, McLellan, & Kosten, 2004). Despite this progress, the treatment of addiction in clinical practice often remains a matter of trial and error. Some reasons for this difficulty are as follows. First, to date, no one treatment has been found that works well for most patients; that is, patients are heterogeneous in response to any specific treatment. Second, as many authors have pointed out (McLellan, 2002; McLellan, Lewis, O’Brien, & Kleber, 2000), addiction is often a chronic condition, with symptoms waxing and waning over time. Third, relapse is common. Therefore, the clinician is faced with, first, finding a sequence of treatments that works initially to stabilize the patient and, next, deciding which types of treatments will prevent relapse in the longer term. To inform this sequential clinical decision making, adaptive treatment strategies, that is, treatment strategies shaped by individual patient characteristics or patient responses to prior treatments, have been proposed (Greenhouse, Stangl, Kupfer, & Prien, 1991; Murphy, 2003, 2005; Murphy, Lynch, Oslin, McKay, & Tenhave, 2006; Murphy, Oslin, Rush, & Zhu, 2007; Lavori & Dawson, 2000; Lavori, Dawson, & Rush, 2000; Dawson & Lavori, 2003). Here is an example of an adaptive treatment strategy for prescription opioid dependence, modeled with modifications after a trial currently in progress within the Clinical Trials Network of the National Institute on Drug Abuse (Weiss, Sharpe, & Ling, 2010). . . . Example . . . . . . First, provide all patients with a 4-week course of buprenorphine/naloxone (Bup/Nx) plus medical management (MM) plus individual drug counseling (IDC) (Fiellin, Pantalon, Schottenfeld, Gordon, & O’Connor, 1999), culminating in a taper of the Bup/Nx. If at any time during these 4 weeks the patient meets the criterion for nonresponse, a second, longer treatment with Bup/Nx (12 weeks) is provided, accompanied by MM and cognitive behavior therapy (CBT). However, if the patient remains abstinent from opioid use during those 4 weeks, that is, responds to initial treatment, provide 12 additional weeks of relapse prevention therapy (RPT). . . .

Keywords:   Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE), Robustness analysis, Sequenced Treatment Alternatives to Relieve Depression (STAR*D), Sequential multiple assignment trial (SMART)

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