The Development of Medications for the Treatment of Opiate and Cocaine Addictions

Issues for the Government and Private Sector

Author: Earley, Laurence E.; Liverman, Catharyn T.; Fulco, Carolyn E.
Publisher: National Academies Press
ISBN: 9780309052443
eISBN Pdf: 9780309587914
eISBN Epub: 9780309176521
Place of publication: United States
Year of digital publication: 1995
Month: January
Pages: 271
DDC: 615
Language: English

Caption

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.

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&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

Subjects

Back

Viewers online

Text
Audio

Download options

Adobe DRM
Loan duration: 21 days
Format: EPUB / PDF

Existing customer

Email

Password

NEW USER

The Development of Medications for the Treatment of Opiate and Cocaine Addictions

Issues for the Government and Private Sector

Subjects

Viewers online

Download options