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Protocol Template: Observational Research Study OCR Interventional_Drugs/Device_Protocol_Template Version: 3.0 OCR Template Date: 09-03-13 [TITLE PAGE – REVISED IRB PROTOCOL] PROTOCOL TITLE: A Randomized, Double-Blinded, Placebo-Controlled Study to Determine if Caffeine Citrate Accelerates Emergence from Anesthesia PI: Name: Aaron Fox, Ph.D. Telephone: (773) 702-2667 Fax: E-mail: [email protected] CO-I(S): Name: Zheng (Jimmy) Xie, M.D., Ph.D. Telephone: (773) 702-2667 Fax: E-mail: [email protected] FUNDING: NIH 1R01GM116119 – 01 09/01/2015 – 08/30/2019 PI: Fox Reversing Anesthesia with Caffeine Patients who are anesthetized, wake after their bodies clear the anesthetic. Our preliminary studies found that in rodents that caffeine could dramatically accelerate emergence from anesthesia. Preliminary data from a Pilot study in human subjects suggest that humans show a similar response to caffeine. The goal in this application is to determine the mechanism for the emergence and to test whether caffeine can accelerate emergence from anesthesia in human subjects. SPONSOR: Name: Principal Investigator, Aaron Fox, Ph.D. Address: The University of Chicago Neurobiology, Pharmacology and Physiology 947 E. 58th Street Telephone: (773) 702-2667 TYPE OF RESEARCH: Interventional, drug studies INTERVENTION: Study Drug Caffeine Citrate MANUFACTURER OF INTERVENTION (if applicable): Bedford Labs IND OR IDE # (applicable for IND/IDE-regulated studies): 127863 NAME OF PERSON WHO HOLDS IND OR IDE (if applicable): Aaron Fox, Ph.D. Page 1 of 71 November 3, 2016 Confidential IRB Approval Date: Author(s) IRB approved Version#: OCR Interventional_Drugs/Device_Protocol_Template Version: 3.0 OCR Template Date: 09-03-13 PROTOCOL NUMBER: PROTOCOL VERSION: 2.0 PROTOCOL VERSION DATE: Page 2 of 71 November 3, 2016 Confidential IRB Approval Date: Author(s) IRB approved Version#: OCR Interventional_Drugs/Device_Protocol_Template Version: 3.0 OCR Template Date: 09-03-13 TABLE OF CONTENTS PAGE 1. INTRODUCTION ………………………………………………………………… 1.1 Background and Rationale………………………………………… 1.2 Objectives …………………………………………………………. 2. STUDY DESIGN 2.1 Type of Study ……………………………………………………… 2.2 Duration of Study ………………………..………………………… 2.3 Schedule of Events…………………………………………………. 2.4 Sequence and Duration of all Study Periods……………………….. 2.5 Method for Assigning Subjects to Treatment Groups……………… 2.6 Blinding…………………………………………………………….. 2.7 Primary Study Endpoints…………………………………………... 2.8 Secondary Study Endpoints………………………………………… 2.9 Primary Safety Endpoints…………………………………………... 3. SUBJECT SELECTION AND WITHDRAWAL………………………………………. 3.1 Number of Subjects…………………………………………………. 3.2 Gender, Age, Racial and Ethnic Origin of Subjects………………… 3.5 Inclusion Criteria……………………………………………………. 3.6 Exclusion Criteria…………………………………………………… 3.7 Vulnerable Subjects…………………………………………………. 3.8 Subject Identification & Recruitment……………………………….. 3.9 Location……………………………………………………………... 3.10 Payment to Subjects…………………………………………………. 3.11 Informed Consent Process…………………………………………... 3.12 Subject Withdrawal Following Study Completion..………………… 3.13 Subject Withdrawal Before Completion (i.e., early termination)……. 3.14 Data Collection and Follow-up on Early Withdrawal Subjects……... 4. STUDY DRUG……………………………………………………………. A. Drug Study: 4.1A Formulation of Study Drug………………………………………….. 4.2A Treatment Regimen………………………………………………….. 4.3A Preparation and Administration of Study Drug……………………… 4.4A Subject Compliance Monitoring…………………………………….. 4.5A Concomitant Medications and Therapies……………………………. 4.6A Packaging and Labeling……………………………………………... 4.7A Receipt of Drug Supplies……………………………………………. 4.8A Product Storage and Stability………………………………………... 4.9A Dispensing of Study Drug…………………………………………… 4.10A Return or Destruction of Study Drug……………………………….. 5. STUDY PROCEDURES 5.1 Screening Session 1…………………………………….…………… 5.2 Anesthesia Sessions 2-3..……………………………………………….. 6. STATISTICAL PLAN 6.1 Sample Size Determination…………………………………………. 6.2 Statistical Methods………………………………………………….. Page 3 of 71 November 3, 2016 Confidential IRB Approval Date: Author(s) IRB approved Version#: OCR Interventional_Drugs/Device_Protocol_Template Version: 3.0 OCR Template Date: 09-03-13 6.3 Subject Population(s) for Analysis………………………………….. 7. RISKS AND BENEFITS 7.1 Risks and Likelihood of Occurrence ………………………………. 7.2 Potential Direct Benefits to Subject…………………………………. 8. SAFETY AND ADVERSE EVENTS …………………………………………………. 8.1 Safety……………………………………………………………….. 8.2 Adverse Events…………………………………………………....... 8.3 Responsibilities……………………………………………………… 8.4 Documenting and Reporting Adverse Events……………………… 8.5 Classifying Adverse Events………………………………………… 8.6 Unblinding procedures……………………………………………… 8.7 Data Safety Monitoring Plan……………………………………….. 9. DATA HANDLING AND RECORD KEEPING ………………………………………. 9.1 Data Management Responsibilities………………………………… 9.2 Data Capturing Methods………………………………………….... 9.3 Source Documents…………………………………………………. 9.4 Records Retention………………………………………………….. 9.5 Confidentiality……………………………………………………… 10. STUDY MONITORING, AUDITING AND INSPECTION……………………………… 10.1 Study Monitoring Plan……………………………………………… 10.2 Auditing and Inspecting……………………………………………. 11. FINANCIAL CONSIDERATIONS………………………………………………….. 12. ETHICAL CONSIDERATIONS ……………………………………………………. 12.1 Institutional Review Board (IRB) approval………………………… 12.2 Ethical and Scientific Conduct of the Clinical Study……………… 12.3 Subject Informed Consent…………………………………………. 13. CONFLICT OF INTEREST ………………………………………………………... 14. PUBLICATION PLAN ……………………………………………………………. 15. REFERENCES …………………………………………………………………… 16. APPENDIXES ……………………………………………………………………. A. INFORMED CONSENT FORM …………………………………………….. B. SCHEDULE OF EVENTS (SCHEMA) ………………………………………. C. DATA SAFETY MONITORING PLAN ……………………………………… Page 4 of 71 November 3, 2016 Confidential IRB Approval Date: Author(s) IRB approved Version#: OCR Interventional_Drugs/Device_Protocol_Template Version: 3.0 OCR Template Date: 09-03-13 STUDY SUMMARY (DRUGS) A Randomized, Double-Blinded, Placebo-Controlled Study TITLE to Determine if Caffeine Citrate (caffeine) Accelerates Emergence from Anesthesia To determine if caffeine will accelerate emergence from OBJECTIVES anesthesia. Determine whether subjects wake more rapidly from anesthesia after administration of caffeine as measured by the PRIMARY OBJECTIVE time between terminating anesthetic and the reinstatement of the gag reflex. Determine whether subjects wake more rapidly from anesthesia after administration of caffeine as measured by the time between terminating anesthetic and responding to SECONDARY simple commands (“squeeze my hand”). OBJECTIVES Normally patients show cognitive impairments for hours after waking from anesthesia. We wish to determine whether caffeine administration ameliorates the cognitive impairment. STUDY CENTER(S) Single-center at University of Chicago NUMBER OF SUBJECTS Up to 8 Healthy male, ages 25-40 with no systematic diseases or conditions, metabolic equivalents of functional capacity, low risk for Obstructive Sleep Apnea, no history of arrhythmia, DIAGNOSIS AND MAIN BMI < 30 kg/m2, no personal or family history of malignant INCLUSION CRITERIA hyperthermia, no history of any mental illness, no history of drugs or alcohol abuse, no history of seizure disorders or head trauma DURATION OF SUBJECT Subjects will be on study for up to 10 weeks PARTICIPATION AND DURATION OF STUDY INVESTIGATIONAL Caffeine Citrate PRODUCT 15 mg/kg body weight, given intravenously 10 min before DOSE, ROUTE, REGIMEN the end of 1 hour isoflurane anesthesia Page 5 of 71 November 3, 2016 Confidential IRB Approval Date: Author(s) IRB approved Version#: OCR Interventional_Drugs/Device_Protocol_Template Version: 3.0 OCR Template Date: 09-03-13 DURATION OF Study drug given intravenously across a 10 min time ADMINISTRATION window STATISTICAL In this crossover study volunteers will serve as their own METHODOLOGY controls. The data will be analyzed with a paired t-test. Page 6 of 71 November 3, 2016 Confidential IRB Approval Date: Author(s) IRB approved Version#: OCR Interventional_Drugs/Device_Protocol_Template Version: 3.0 OCR Template Date: 09-03-13 LIST OF ABBREVIATIONS EXAMPLES UCMC UNIVERSITY OF CHICAGO MEDICAL CENTER UC UNIVERSITY OF CHICAGO OCR OFFICE OF CLINICAL RESEARCH IRB INSTITUTIONAL REVIEW BOARD URA UNIVERSITY RESEARCH ADMINISTRATION ORS OFFICE OF RESEARCH SERVICES CRSO CLINICAL RESEARCH SUPPORT OFFICE UCCRC UNIVERSITY OF CHICAGO CANCER CLINICAL RESEARCH CENTER CRC CLINICAL RESOURCE CENTER (FORMERLY GCRC) DSMB DATA SAFETY AND MONITORING BOARD FDA FOOD AND DRUG ADMINISTRATION CDER CENTER FOR DRUG EVALUATION AND RESEARCH CBER CENTER FOR BIOLOGICS EVALUATION AND RESEARCH NIH NATIONAL INSTITUTES OF HEALTH NCI NATIONAL CANCER INSTITUTE CTSA CLINICAL AND TRANSLATIONAL SCIENCE AWARD ITM INSTITUTE FOR TRANSLATIONAL MEDICINE Page 7 of 71 November 3, 2016 Confidential IRB Approval Date: Author(s) IRB approved Version#: OCR Interventional_Drugs/Device_Protocol_Template Version: 3.0 OCR Template Date: 09-03-13 1. INTRODUCTION 1.1 BACKGROUND AND RATIONALE 1.1.1 Background: Disease and current understanding of disease Our lab has studied anesthetics for almost fifteen years. We, as well as other labs, found that anesthetics inhibit neurotransmitter release (Crowder et al.; van Swinderen et al., 1999; Winegar & MacIver, 2006; Herring et al., 2009; Herring et al., 2011; Saifee et al.). We thought that if we could reverse this action that we would be able to reverse aspects of anesthesia. In our preliminary studies, several drugs were studied that normally facilitate neurotransmitter release. If inhibiting neurotransmitter
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