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Medication Development for the Treatment of Cocaine Dependence: Issues in Clinical Efficacy Trials



NIDA Research Monograph, Number 175 [Printed in 1998]

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Table of Contents

Preface-----1
Betty Tai, Charles V. Grudzinskas, Nora Chiang, and Peter Bridge

Goals and Rationale for Pharmacotherapeutic Approach in Treating Cocaine Dependence: Insights From Basic and Clinical Research-----5
Mary Jeanne Kreek

Overview of Potential Treatment Medications for Cocaine Dependence-----36
Elinore F. McCance

Methodologic Recommendations for Cocaine Abuse Clinical Trials: A Clinician-Researcher's Perspective-----73
Edward V. Nunes

Management of Clinical Trials With New Medications for Cocaine Dependence and Abuse-----96
Ari Kiev

Outcome Measurement Considerations: Pharmacological Treatments for Substance Abuse-----118
Karla Moras

Variability in Treatment-Seeking Cocaine Abusers: Implications for Clinical Pharmacotherapy Trials-----137
Kathleen M. Carroll, Charla Nich, and Bruce J. Rounsaville

Baseline Assessment, Study Entry, and Stabilization: Double-Blind Clinical Trials in Drug Dependence-----158
John Grabowski, Gila Arnoni, Ronith Elk, Howard Rhoades, and Joy Schmitz

The Addiction Severity Index in Clinical Efficacy Trials of Medications for Cocaine Dependence-----182
John S. Cacciola, Arthur I. Alterman, Charles P. O'Brien, and A. Thomas McLellan

Cognitive-Neuromotor Assessment of Substance Abuse: Focus on Issues Related to Cocaine Abuse Treatment-----192
E.H. Ellinwood, Jr. and T.H. Lee

Treatment Effectiveness Score as an Outcome Measure in Clinical Trials-----208
Walter Ling, Steven Shoptaw, Donald Wesson, Richard A. Rawson, Margaret Compton, and C. James Klett

Pharmacokinetics of Cocaine: Considerations When Assessing Cocaine Use by Urinalysis-----221
Reese T. Jones

Quantitative Urine Levels of Cocaine and Other Substances of Abuse-----235
Jeffery N. Wilkins

Use of Quantitative Urinalysis in Monitoring Cocaine Use-----253
Kenzie L. Preston, Kenneth Silverman, Charles R. Schuster, and Edward J. Cone

Is Quantitative Urinalysis More Sensitive?-----265
Shou-Hua Li, Nora Chiang, Betty Tai, Charles K. Marschke, and Richard L. Hawks

Comparison of Immunoassays for Semiquantitative Measurement of Benzoylecgonine in Urine-----287
Rodger L. Foltz, Christine Botelho, Scott A. Reuschel, David J. Kuntz, David E. Moody, and Gloria M. Bristow

TAppendix I: Workshop Summary Outcome Measures and Success Criteria-----303
Betty Tai

Appendix II: Workshop Summary Clinical Decision Tree for Cocaine Addiction Pharmacotherapy-----312
Betty Tai, Charles V. Grudzinskas, Peter Bridge, and Nora Chiang

Ordering Information-----318




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