Development of medications for the treatment of opiate and cocaine addictions : issues for the government and private sector

Development of medications for the treatment of opiate and cocaine addictions issues for the government and private sector

Detalles Bibliográficos
Autores Corporativos: National Institute on Drug Abuse. Committee to Study Medication Development and Research (-), Institute of Medicine (U.S.). Division of Biobehavioral Sciences and Mental Disorders
Otros Autores: Fulco, Carolyn (-), Liverman, Catharyn T., Earley, Laurence E.
Formato: Libro electrónico
Idioma:Inglés
Publicado: Washington, DC : National Academy Press 1995.
Edición:1st ed
Materias:
Drug addiction > Treatment.
Cocaine abuse > Treatment.
Substance abuse > Treatment.
Ver en Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009820333806719
Tabla de Contenidos:
  • 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
  • REFERENCES
  • 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
  • REFERENCES
  • 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
  • Food and Drug Administration
  • Drug Enforcement Administration
  • Office of Protection from Research Risks
  • Pharmaceutical Industry
  • ASSESSMENT OF THE MEDICATIONS DEVELOPMENT DIVISION
  • Staff and Resources
  • Drug-Discovery Programs
  • Clinical Trials
  • Clinical-Research Training
  • Relationships with Regulatory Agencies
  • Interaction with the Private Sector
  • SUMMARY
  • CONCLUSIONS AND RECOMMENDATIONS
  • REFERENCES
  • 4 Treatment Setting and Effectiveness
  • TREATMENT SETTING
  • Opiate Addiction
  • Cocaine Addiction
  • DEMOGRAPHIC AND FINANCIAL PROFILE
  • Opiate-Dependent Patients
  • Cocaine-Dependent Patients
  • TREATMENT EFFECTIVENESS AND COST-EFFECTIVENESS
  • Methadone Maintenance Treatment
  • Effectiveness
  • Cost-Effectiveness
  • Cocaine Addiction Treatment
  • Effectiveness
  • Cost-Effectiveness
  • CONCLUSIONS AND RECOMMENDATION
  • REFERENCES
  • 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
  • REFERENCES
  • 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
  • Conclusions and Recommendations
  • COMPREHENSIVE DRUG ABUSE CENTERS
  • Proposed Model
  • Existing Research and Training Centers
  • CSAT Centers
  • NIDA Research Centers
  • Conclusions and Recommendations
  • SUMMARY
  • REFERENCES
  • 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
  • CONCLUSIONS
  • REFERENCES
  • 8 State Laws and Regulations
  • STATE REGULATORY LANDSCAPE
  • Scheduling
  • 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
  • CONCLUSIONS
  • RECOMMENDATIONS
  • Interim Actions
  • Long-Term Actions
  • REFERENCES
  • 9 Market Obstacles and Creating Incentives
  • MARKET OBSTACLES TO PRIVATE-SECTOR INVESTMENT
  • Nature and Size of the Market
  • Drug Pricing and Intellectual Property Rights
  • Societal Stigma
  • Clinical Research on Anti-Addiction Medications
  • Product Liability
  • NEED FOR FEDERAL LEADERSHIP
  • CONCLUSIONS
  • OPTIONS FOR FURTHER CONSIDERATION
  • REFERENCES
  • 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
  • Background
  • Preclinical Research
  • Clinical Research
  • Elements of Success
  • NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES DRUG DISCOVERY AND DEVELOPMENT PROGRAMS
  • Background
  • Preclinical Research
  • Clinical Research
  • Elements of Success
  • REFERENCES
  • 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
  • CONCLUSIONS
  • REFERENCES
  • Appendix H Acronyms.

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