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

• Pubblicazione: Washington, DC, : National Academy Press, 1995
• Edizione: 1st ed.
• Descrizione fisica: xvii, 250 p. : ill
• Disciplina: 616.86/32061
• Soggetto topico: Drug addiction - Treatment; Cocaine abuse - Treatment; Substance abuse - Treatment
• Altri autori: FulcoCarolyn LivermanCatharyn T EarleyLaurence E
• Note generali: Committee chairman: Laurence E. Earley.; Support for this study was provided by the National Institute on Drug Abuse.
• Nota di bibliografia: Includes bibliographical references.
• Nota di contenuto: 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.
• Titolo autorizzato: Development of medications for the treatment of opiate and cocaine addictions
• ISBN: 0-309-17652-2; 1-280-19299-2; 9786610192991; 0-309-58791-3; 0-585-02541-X
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910828852203321
• Lo trovi qui: Univ. Federico II