Development of medications for the treatment of opiate and cocaine addictions : issues for the government and private sector / Carolyn E. Fulco, Catharyn T. Liverman, and Laurence E. Earley, editors ; Committee to Study Medication Development and Research at the National Institute on Drug Abuse, Division of Biobehavioral Sciences and Mental Disorders, Institute of Medicine.

Format:

Book

Contributor:

Fulco, Carolyn.

Liverman, Catharyn T.

Earley, Laurence E.

National Institute on Drug Abuse. Committee to Study Medication Development and Research.

Institute of Medicine (U.S.). Division of Biobehavioral Sciences and Mental Disorders.

Language:

English

Subjects (All):

Drug addiction--Treatment.

Drug addiction.

Cocaine abuse--Treatment.

Cocaine abuse.

Substance abuse--Treatment.

Substance abuse.

Physical Description:

xvii, 250 p. : ill.

Edition:

1st ed.

Place of Publication:

Washington, DC : National Academy Press, 1995.

Language Note:

English

Summary:

Pharmacotherapy, as a means of treating drug addiction in combination with other treatment modalities, has received too little attention from the research community, the pharmaceutical industry, public health officials, and the federal government. Medications to combat drug addiction could have an enormous impact on the medical consequences and socioeconomic problems associated with drug abuse, both for drug-dependent individuals and for American society as a whole. This book examines the current environment for and obstacles to the development of anti-addiction medications, specifically those for treating opiate and cocaine addictions, and proposes incentives for the pharmaceutical industry that would help overcome those obstacles and accelerate the development of anti-addiction medications.

Contents:

Development of Medications for the Treatment of Opiate and Cocaine Addictions: Issues for the Government and Private Sector

Copyright

Acknowledgments

Preface

Note to the Reader

Contents

Executive Summary

STATE OF THE SCIENTIFIC KNOWLEDGE ON ADDICTION

NIDA'S MEDICATIONS DEVELOPMENT DIVISION

EFFECTIVENESS OF TREATMENT

TREATMENT FINANCING

TRAINING AND EDUCATION

FEDERAL REGULATORY ISSUES

Food and Drug Administration

Drug Enforcement Administration

STATE REGULATORY ISSUES

Interim Actions

Long-Term Actions

MARKET OBSTACLES AND CREATING INCENTIVES

Size of the Market

Drug Pricing and Intellectual Property Rights

Societal Stigma

NEED FOR FEDERAL LEADERSHIP

CONCLUSIONS

OPTIONS FOR FURTHER CONSIDERATION

REFERENCES

1 Introduction

PUBLIC-HEALTH REPERCUSSIONS OF ILLICIT DRUG USE

Health Consequences: Violence

Health Consequences: AIDS

Health Consequences: Tuberculosis

Health Consequences: Drug-exposed Infants

ECONOMIC COSTS OF ILLICIT DRUG USE TO SOCIETY

EXTENT OF ILLICIT DRUG USE

ROLE OF PHARMACOTHERAPY

2 Overview of the State of Scientific Knowledge Concerning Drug Addiction

CONCEPTS OF DRUG ADDICTION

BIOLOGICAL CORRELATES AND PSYCHOPHARMACOLOGY OF ADDICTION

Opiate Addiction

Cocaine Addiction

MDD AND STRATEGIES FOR THE DISCOVERY OF A COCAINE MEDICATION: DESCRIPTION AND CRITICAL ANALYSIS

Introduction

Source of Compounds

Medication Preclinical Screening

In Vitro Screen-Receptors and Mechanisms of Action

In Vivo Screen-Behavioral Tests

Specific Conclusions and Recommendations for the MDD

Clinical Trials

Human Behavioral Models

CONCLUSIONS AND RECOMMENDATIONS

3 Assessment of the Medications Development Division

STRUCTURE AND FUNCTIONS OF THE MEDICATIONS DEVELOPMENT DIVISION.

Mission and History

Research Focus on Opiates and Cocaine

Program Objectives

Organizational Structure

Budget Process

Resources and Funding Instruments

Types of Grants and Contracts

Interagency Agreements

CRADAs

Screening Agreements

Training

RELATIONSHIPS WITH OTHER FEDERAL AGENCIES AND THE PRIVATE SECTOR

Office of Protection from Research Risks

Pharmaceutical Industry

ASSESSMENT OF THE MEDICATIONS DEVELOPMENT DIVISION

Staff and Resources

Drug-Discovery Programs

Clinical-Research Training

Relationships with Regulatory Agencies

Interaction with the Private Sector

SUMMARY

4 Treatment Setting and Effectiveness

TREATMENT SETTING

DEMOGRAPHIC AND FINANCIAL PROFILE

Opiate-Dependent Patients

Cocaine-Dependent Patients

TREATMENT EFFECTIVENESS AND COST-EFFECTIVENESS

Methadone Maintenance Treatment

Effectiveness

Cost-Effectiveness

Cocaine Addiction Treatment

CONCLUSIONS AND RECOMMENDATION

5 Treatment Financing and Trends in Health Insurance

FINANCING OF TREATMENT

Financing the Treatment of Opiate Addiction

Financing the Treatment of Cocaine Addiction

FINANCING OF LAAM FOR THE TREATMENT OF OPIATE ADDICTION

IMPACT OF HEALTH INSURANCE TRENDS ON MEDICATIONS DEVELOPMENT

Trends in Drug Abuse Treatment Benefits

6 Training and Education

EXPANDING THE CORE OF RESEARCHERS AND CLINICIANS

Training Programs

Fellowships

Certification

Conclusions and Recommendations

INCREASING KNOWLEDGE AND SKILLS AMONG PRIMARY CARE PHYSICIANS

Required Education in Medical Schools

Residency Training.

Continuing Education

COMPREHENSIVE DRUG ABUSE CENTERS

Proposed Model

Existing Research and Training Centers

CSAT Centers

NIDA Research Centers

7 Federal Laws and Regulations

CREATION OF A DRUG BY THE PHARMACEUTICAL INDUSTRY

FOOD AND DRUG ADMINISTRATION

Recent Initiatives to Expedite Availability of New Drugs

Market Exclusivity and Orphan Drug Status

FDA Guidelines on Evaluation of Anti-Addiction Drugs

DRUG ENFORCEMENT ADMINISTRATION

Scheduling

Quotas

Regulatory Authority Over Anti-Addiction Drugs In Development

8 State Laws and Regulations

STATE REGULATORY LANDSCAPE

Treatment

Admission Criteria

Staffing Requirements

Patient Registries

Drug Screening

Medication Take-Home Policies

Clinical Research

LAAM: A CASE STUDY

Federal Regulations

State Regulations

Scheduling/Rescheduling

Treatment Regulations

Clinic Approval

RECOMMENDATIONS

9 Market Obstacles and Creating Incentives

MARKET OBSTACLES TO PRIVATE-SECTOR INVESTMENT

Nature and Size of the Market

Clinical Research on Anti-Addiction Medications

Product Liability

Appendix A Acknowledgements

Appendix B Organization and Mission Statements of NIDA's Medications Development Division and Its...

MEDICATIONS DEVELOPMENT DIVISION MISSION STATEMENT

Biometrics Branch Mission Statement

Chemistry and Pharmaceutics Branch Mission Statement

Clinical Trials Branch Mission Statement.

Pharmacology and Toxicology Branch Mission Statement

Regulatory Affairs Branch Mission Statement

Appendix C Diagnostic Criteria for Psychoactive Substance Dependence

Appendix D Survey of Pharmaceutical Companies

ATTACHMENT 1

ATTACHMENT 2

Appendix E Model Federal Programs in Pharmaceutical R&amp

D

ANTIEPILEPTIC DRUG DEVELOPMENT PROGRAM

Background

Elements of Success

NATIONAL CANCER INSTITUTE CANCER-DRUG DISCOVERY AND DEVELOPMENT PROGRAMS

Preclinical Research

NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES DRUG DISCOVERY AND DEVELOPMENT PROGRAMS

Appendix F Workshop Agenda and Participants

WORKSHOP AGENDA

PARTICIPANT LIST

Appendix G Health Care Reform Legislation

UNIVERSALITY OF COVERAGE

PRESCRIPTION DRUG BENEFITS

DRUG ABUSE TREATMENT BENEFITS

INSURANCE REFORM

FINANCING HEALTH CARE REFORM AND THE FATE OF MEDICAID

Appendix H Acronyms.

Notes:

Committee chairman: Laurence E. Earley.

Support for this study was provided by the National Institute on Drug Abuse.

Includes bibliographical references.

ISBN:

9786610192991

9780309176521

0309176522

9781280192999

1280192992

9780309587914

0309587913

9780585025414

058502541X

OCLC:

923262252