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Statistical Issues in Clinical Trials for Treatment of Opiate Dependence



NIDA Research Monograph, Number 128 [Printed in 1992]

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Table of Contents

Introduction-----1
Ram B. Jain

Drug Dependence (Addiction) and Its Treatment-----6
Frank J. Vocci, Jerome H. Jaffe, and Ram B. Jain

Background and Design of a Controlled Clinical Trial (ARC 090) for the Treatment of Opioid Dependence-----14
Rolley E. Johnson and Paul J. Fudala

Clinical Endpoints: Discussion Session-----25
Ram B. Jain

Design of Clinical Trials for Treatment of Opiate Dependence: What Is Missing?-----29
Ram B. Jain

Comments-----37
Sudhir C. Gupta

Rejoinder-----42
Ram B. Jain

Summary of Discussion-----44
Ram B. Jain

Efficacy of Urinalysis in Monitoring Heroin and Cocaine Abuse Patterns: Implications in Clinical Trials for Treatment of Drug Dependence-----46
Edward J. Cone and Sandra L. Dickerson

Comments-----59
Nancy L. Geller

Summary of Discussion-----62
Ram B. Jain

Open/Panel Discussion: Design Issues-----64
Ram B. Jain

A Bayesian Nonparametric Approach to Analysis of Treatment for Drug Dependence Data-----70
Ram C. Tiwari

Three Estimators of the Probability of Opiate Use From Incomplete Data-----82
Alan J. Gross

Summary of Discussion-----95
Ram B. Jain

Issues in the Analysis of Clinical Trials for Opiate Dependence-----97
Dean Follmann, Margaret Wu, and Nancy Geller

Summary of Discussion-----114
Ram B. Jain

Analysis of Clinical Trials for Treatment of Opiate Dependence: What Are the Possibilities?-----116
Ram B. Jain

Summary of Discussion-----135
Ram B. Jain

Toward a Dynamic Analysis of Disease-State Transition Monitored by Serial Clinical Laboratory Tests-----137
T.S. Weng

Summary of Discussion-----158
Alan J. Gross

A Markov Model for NIDA Data on Treatment of Opiate Dependence-----160
Mei-Ling Ting Lee

Summary of Discussion-----168
Alan J. Gross

Open/Panel Discussion: Analysis Issues-----170
Ram B. Jain

Open/Panel Discussion: General Issues-----176
Ram B. Jain

List of Participants-----182

List of NIDA Research Monographs-----186




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