Transcription
THIRTY-NINTH ANNPAL REPORTof theRESEARCH ADVISORY PANELOF CALIFORNIA2009Prepared for theLEGISLATURE AND GOVERNORRESEARCH ADVISORY PANEL OF CALIFORNIA455 Golden Gate Avenue- Suite 11000San Francisco, California 94102-7004www .ag.ca.gov/research
2009 PANEL MEMBERSRESEARCH ADVISORY PANEL OF CALIFORNIAEdward P. O'Brien, J.D.Panel ChairmanAppointed by Attorney GeneralAntonello Bonci, M.D.Appointed by the University of California at San FranciscoDesignated University of CaliforniaDaniel P. Holschneider, M.D.· Appointed by the University of Southern CaliforniaDesignated private universityPeter Koo, Pharm.D.Appointed by the State Board of PharmacyJohn Mendelson, M.D.Appointed by the California Medical AssociationDesignated professional medical societyLaurence R. Upjohn, Pharm.D.Appointed by the Department of Health ServicesY. Jennifer Ahn, Pharm.D.Executive OfficerRAPC Website: www.ag.ca.gov/researchE-mail contact: jennifer.ahn@doj.ca.govThis report represents a consensus among Panel members acting as individual experts. Itdoes not represent policies or positions of the appointing agencies nor have those agenciesbeen consulted by the Panel during its function or during the preparation of this report.
TABLE OF CONTENTSPageSUMMARY OF 2009 PANEL ACTIVITIES3SELECTED RESEARCH FINDINGS3TABLE 1 - Research Studies approved in 20097TABLE 2 - Research Studies closed in 200915APPENDICESAppendix A : Currently Open Schedule I and IINon-Human & Academic Human Studies21Appendix B - Currently Open Schedule IIClinical Drug Trial Studies29Appendix C - Currently Open Research Studieson the Treatment of Controlled Substance Abuse37Appendix D - Pertinent Sections - California Health and Safety Code§ 11213 -Persons and researches using controlled substances§ 11480 & 11481 -Research Advisory Panel§ 11603 & 11604 - Attorney General§ 24172- Experimental subject's bill ofrights§ 24173- nformed consent3939404142
SUMMARY OF 2009 PANEL ACTIVITIESDuring 2009 the Panel reviewed forty research study submissions. Thirty-six wereapproved by the Panel. Among thirty-six approved studies, fifteen studies wereAcademic research studies including five Substance Abuse Treatment researchprotocols and twenty-one studies were Clinical Drug Trial research protocols.Twenty-one research studies were completed or, in a few cases, terminated in 2009, andthey were closed' on the Panel's records.At the end of 2009, the Panel was monitoring 101 active research projects. NoteAppendices A, B, and C for specific listings.As part of the Panel's supervisory responsibility, ongoing projects are monitored bymeans of annual reports, Significant Adverse Event (SAE) reports and site visits.Approval may b withdrawn if the study deviates significantly from the approvedprotocol.Table 1 is a list of the studies approved by the Panel in 2009 and Table 2 is a list of thestudies closed by the Panel in 2009.SELECTED RESEARCH FINDINGSBelow are brief summary reports of several Panel approved projects which are ofinterest and indicative of the types of controlled substance and substance abusetreatment research projects currently ongoing in California:Dr. Timothy L. Wigal, Ph.D. and colleagues at the UCI Child Development center inIrvine, California have completed a study titled "Brain Dopamine Function in Adultswith Attention Deficit/Hyperactivity Disorder (ADHD)" The results of this study wererecently published in the Journal of the American Medical Association and summarizedwith the following findings:Attention-deficit/hyperactivity disorder (ADHD)- characterized by symptoms ofinattention and hyperactivity-impulsivity - is the most prevalent childhoodpsychiatric disorder that frequently persists into adulthood, and there isincreasing evidence ofreward-motivation deficits in this disorder.To evaluate biological bases that might underlie a reward/motivation deficit byimaging key components of the brain dopamine reward pathway(mesoaccumbens). We used positron emission tomography to measure3
dopamine synaptic makers in 53 nonmedicated adults with ADHD and 44healthy controls between 2001-2009 at Brookhaven National Laboratory. Wemeasured specific binding of positron emission tomographic radio ligands fordopamine transporters (DAT) quantified as binding potential.For both ligands, statistical parametric mapping showed that specific bindingwas lower in ADHD than in controls in regions of the dopamine reward pathwayin the left side of the brain. Region-of-interest analyses corroborated thesefindings. As conclusion, a reduction in dopamine synaptic makers associatedwith symptoms of inattention was shown in the dopamine reward pathway ofparticipants with ADHD.Dr. Matthew Schreiber, MD, PhD and colleagues at the Ernest Gallo Clinic andResearch Center in Emeryville, California have provided the Panel with the followingsummary of ongoing research titled "Pharmacological and Genetic Study of the Effectsof3,4-methylenedixoymethamphetamine (MDMA) using a moder organism, thenematode Caenorhabditis elegans."Amphetamines are among the most widely abused substances. From a publichealth standpoint, there is substantial concern about the toxicity of thesesubstances, particularly MDMA, which is abused by an especially vulnerablepopulation. The toxicity ofMDMA has been shown in mammalian models, butthe underlying molecular mechanisms mediating this toxicity are still onlypoorly understood. A better understanding of this toxicity would pirmit bettertreatment and prevention of the abuse of these substances. To this end, I amusing a model organism, the nematode C. Elegans, to study MDMA toxicity.This organism's s mple nervous system employs molecular components that arehighly conserved with mammals. This makes study of these organisms relevantto the study ofbasic aspects of mammalian neurobiology, while offering thegreat advantage that genetic studies are possible that would be very difficult orimpossible in mammals. Preliminary work indicates that MDMA has distinctbehavioral effects on this organism, as well as toxicity to the organism as awhole. New computer-assisted techniques developed in this laboratory willallow more accurate and detailed investigation of the neurobehavioral toxicity ofthis substance. As these techniques are implemented, further efforts will bedirected to the identification of the cellular targets responsible for this toxicity,as well as more detailed scrutiny of the neurobehavioral effects of the drug. Intum these studies will facilitate genetic tests to identify molecular components ofthe toxic effects of the substance. It is anticipated that these efforts will lead to abetter understanding of this class of harmful, widely-abused substances.4
Dr. Keith Flower, MD and colleagues at the Addiction Pharmacology ResearchLaboratory at CPMC Research Institute in San Francisco, California have provided thePanel with the following summary of ongoing research titled "A Pilot Trial ofNaltrexone for Methamphetamine Addiction- Role ofthe All8G SNP"Methamphetamine addiction remains a significant public health problem with noknown effective pharmacotherapies. Small clinical trials suggest that oralnaltrexone, an opioid antagonist with known efficacy in treating alcoholism, hasefficacy against amphetamine addiction. In alcoholics, use of sustained releasenaltrexone improves adherence and decreases drinking. Alcoholics who arecarriers ofthe AlliG single nucleotide polymorphism (SNP) ofthe u-opioidreceptor (OPRMl) respond better to naltrexone than do non-carriers. Wepropose conducting the first trial of naltrexone for methamphetamine addiction.We will use the injectable, sustained release formulation and focus on the role ofthe All8G Snp in response to naltrexone. The conventional approach to a full scale outpatient efficacy trial would be to recruit equal numbers of Al18G andwild type subjects and assign them randomly to naltrexone or placebo.However, the relative infrequency of the A118G polymorphism (10-30%) wouldrequire screening many subjects, and is not appropriate for a pilot trial. Ifnaltrexone is effective for methamphetamine addiction, we anticipate a largedifference in response to naltrexone based on the presence or absence of theA118G pplymorphism. Finding such a difference would indicate that a larger,placebo-controlled trial should be conducted. Therefore, we plan to conduct anoutpatient, pilot clinical trial of sustained release naltrexone s a pharmacotherapyfor methamphetamine addiction, comparing responses to a sustained releaseformulation ofnaltrexone in subjects with and without the A118Gpolymorphism. Comparing the effects of naltrexone in these two groups willprovide important data useful in guiding the design of subsequent, moredefinitive studies. In this pilot trial, we utilize several innovative methods to testnaltrexone against methamphetamine addiction. First, we use sustained releasenaltrexone to improve compliance and decrease variability in drug response.Second, we recruit two pharmacogenomically-defined groups - carriers of theA118G SNP, and wild type- and compare response to naltrexone bypharmacogenomic status. Third, we utilize a non-randomized placebo controlgroup from a similar, simultaneously running parallel study to permit effect sizeestimation at essentially no cost. Fourth, we investigate putative mechanisms ofnaltrexone action, which include reduction in craving and impulsivity.·s
6
TABLE 1RESEARCH STUDIESAPPROVED IN 2009PI/ SponsorTitle of Study I Clinical DrugTrial ProtocolGayle C. Baldwin, Ph.D.UCLALos Angeles, CAMethamphetamine Dependence: A NovelLaboratory ModelJohn R. Cashman, Ph.D.Human BioMolecular ResearchInstituteSan Diego, CAMolecular Evolution of Human CocaineCatalysisG. Patrick Dauert, M.D.UC Davis Medical CenterSacramento, CADoes Oral Methadone Use in OpiateReplacement Therapy Prolong the QTcInterval?Keith Flower, M.D.APRL/CPMC Research InstituteSan Francisco, AA Pilot Trial ofNaltrexone forMethamphetamine Addiction- Role oftheA118G SNPGantt Galloway, Pharm.D.APRL/CPMC Research InstituteSan Francisco, CAA Dose Ranging Study of Modafinil forMethamphetamine DependenceGantt Galloway, Pharm.D.APRL/CPMC Research InstituteSan Francisco, CAPhase 1, Double-Blind, Placebo-ControlledAssessment of Potential Interactions BetweenIntravenous Cocaine and lofexidineEdward T. Kisak, Ph.D.Fqubed, Inc.San Diego, CATransdermal Delivery of tetrahydrocannabinol7
Table 1 Cont.PI/ SponsorTitle of Study I Clinical DrugTrial ProtocolKeith Heinzerling, MD, MPHUCLA Dept of Family MedicineLos Angeles, CAPilot Trial of Bupropion versus Placebo forMethamphetamine Abuse in AdolescentsLorrin Koran, M.D.Stanford UniversityStanford, CAFunctional MRI ofD-amphetamine vs.Placebo in Obsessive-Compulsive DisorderAdam Leventhal, Ph.D.USC Keck School of MedicineAlhambra, CAInfluence of Genes and Emotions onmedication EffectsLinghui Li, Ph.D.APRL/CPMC Research InstituteSan Francisco, CAAn Open-Label Stud to Evaluate the Impact ofGenetic Variation in CYP2D6 on thePharmacokinetics and Pharmacodynamics ofMethamphetamine in Healthy AdultsEdythe London, Ph.D. ,UCLALos Angeles, CAA Study to Assess the Cardiovascular,Cognitive, and Subjective Effects ofAtomoxetine in Combination with IntravenousAmphetamineJohn E. Mendelson, M.D.APRL/CPMC Research InstituteSan Francisco, CARole of Serotonin in Acute and SubacuteMDMA EffectsJohn E. Mendelson, M.D.APRL/CPMC Research InstituteSan Francisco, CAA Phase-I, Two-Stage, Double-Blind,Placebo-Controlled, Pharmacokinetics andpharmacodynamic Trial of Low Doses ofIntravenous 6B-Naltrexol (AIK0-150) inOpioid-Dependent Subjects8
Table 1 Cont.PI/ SponsorTitle of Study I Clinical DrugTrial ProtocolRichard Reznichek, M.D.Harbor-UCLA Medical CenterTorrance, CAA prospective, randomized, double-blindstudy comparing the efficacy and safety ofintra nasal fentanyl spray to placebo as ananalgesic in patients undergoing outpatientcystoscopic proceduresSteven Shoptaw, Ph.D .UCLALos Angeles, CAV arenicline vs Placebo in Conjunction withCognitive Behavioral Therapy for theTreatment of Methamphetamine DependenceAcelRx Pharmaceuticals, Inc.Redwood City, CAA Multicenter, Randomized, Placebo Controlled, Crossover Study for theEvaluation of the Safety, Tolerability andEfficacy of ARX-F02 compared to Placebo inthe Treatment of Cancer Breakthrough Pain(AcelRx ARX-C-003)BRC Operations Pty Ltd.Ultimo, NSW, AustraliaInternational Study to Predict OptimizedTreatment in Attention Deficit/.HyperactivityDisorder(BRC iSPOT-A)Cephalon, IncFrazer, PAA Randomized, Double-Bind, Active Controlled Crossover Study to Evaluate theEfficacy and Safety of Fentanyl BuccalTablets Compared With Immediate-ReleaseOxycodone for the Management ofBreakthrough Pain in Opioid-Tolerant patientsWith Chronic Pain, Followed by a 12-WeekOpen-Label Extension to Evaluate the Impactof Fentanyl Buccal Tablets on PatientOutcomes(Cephalon C25608/3056/BPIUS)9---· ---- ---- ----·-- --
Table 1 Cont.PI/ SponsorTitle of Study I Clinical DrugTrial ProtocolNIAID/NIHBethesda, MDA Phase II, Randomized, Double-Blind,Placebo-Controlled Study of Duloxetine andMethadone for the Treatment of HIV Associated Painful Peripheral Neuropathy(DAIDS A5252)OMJSATitusville, NJA Placebo-controlled, Double-blind, Parallel group, Individualized Dosing StudyOptimizing Treatment of Adults withAttention Deficit Hyperactivity Disorder to anEffective Response with OROSMethylphenidate(OMJSA CONCERTA-ATT-3014)Johnson & JohnsonMalvern, PAA Single-Dose Study to Evaluate the RelativeBioavailability of a 1OOmg tamper-ResistantProlonged-Release Formulation (TRF) ofTapentadol with Respect to the PRJProlonged-Release 100mg tablet FormulationUnder Fasted Condition in Japanese HealthySubjects(J&J R331333 PAl 1053)Johnson & JohnsonTitusvilleA Randomized-Withdrawal, Placebo Controlled, Study Evaluating the Efficacy,Safety, and Tolerability, of TapentadolExtended-Release (ER) in Subjects withChronic, Painful Diabetic PeripheralNeuropathy (DPN)(J&J R331333 PAl 3027)10---------- ----
Table 1 Cont.PI/ SponsorTitle of Study I Clinical DrugTrial ProtocolJohnson & JohrlsonTitusvilleA Randomized, Double Blind, Placebo- andActive-Controlled, Parallel-Group,Multicenter Study of Three Dosages of JNJ 31001074 in the Treatment of Adult Subjectswith Attention Deficit/Hyperactivity Disorder(J&J 31001074-ATT-2001)Johnson & JohrlsonMalvern, PAA Single-Dose Study to Evaluate the Effect ofFood on the Pharmacokinetics of a Tamper Resistant prolonged-Release 100mg TabletFormulation ofTapentadol in healthy MaleJapanese Subjects(J&J R331333 PAl 1052)King Pharmaceuticals R & DAustin, TXA Phase III, Randomized, Double-blind,Placebo-controlled, Multicenter, Multiple dose Study of the Safety and Efficacy ofAcuracet TM Tablets for the Treatment ofAcute, Moderate to Severe Postoperative PainFollowing Bunionectomy Surgery in AdultSubjects(King K228-08-3001)Eli Lilly PharmaceuticalsIndianapolis, INA Fixed-Dose, Randomized, Double-Blind,Placebo-Controlled Study of L Y2216684 inPediatric Patients with AttentionDeficit/Hyperactivity Disorder(Lilly H9P-MC-LNBF)11
Table 1 Cont.PI/ SponsorTitle of Study I Clinical DrugTrial ProtocolNeurologic AIDS ResearchConsortium (NARC) at WashingtonUniversity in St. Louis.St. Louis, MOA Phase II, Randomized, Double-Blind,Placebo-Controlled Study of Methadone andCombination of Methadone and SAB378 inHIV -Associated Painful PeripheralNeuropathy(NARC NARC011)NextWave PharmaceuticalsResearch Triangle Park, NCNWP06 in Treatment of Children withADHD: A laboratory Classroom Study(NextWave NWP06-ADD-100)Ortho-McNeil Janssen ScientificAffairs, LLCRaritan, NJA Randomized, Double-Blind, Multi-Center,Parallel-Group Study ofTapentadolImmediate Release (IR) vs. Oxycodone IR forthe Treatment of Subjects with Acute Post Operative Pain Following ElectiveArthroscopic Shoulder Surgery(OMJSA R331333 PAl 3022)QRxPharmaChapel Hill, NCA Randomized, Double-blind, Multicenter,Repeat-dose, Comparison of AnalgesicEfficacy and Safety of Q8003 with Oxycodoneand Morphine for the Management of AcuteModerate to Severe Postoperative PainFollowing Bunionectomy Surgery(QRxPharma Q8003-008)QRxPharmaChapel Hill, NCA Randomized, Double-blind Study of TheAnalgesic Efficacy and Safety of FlexibleDose Q8003 versus Low Dose Q8003 inPatients Who Have Undergone PrimaryUnilateral Total Knee Arthroplasty(QRxPharma Q8003-009)12'------- -----------------
Table 1 Cont.PI/ SponsorTitle of Study I Clinical DrugTrial ProtocolShirePhiladelphia, P AA Phase 4, Double-Blind, Multi-center,Placebo-Controlled, Randomized Withdrawal,Safety and Efficacy Study of SPD489 inAdults Aged 18-55 with AttentionDeficit/Hyperactivity Disorder (ADHD)(Shire SPD489-40 1)ShireRaleigh, NCA Phase II, Multicenter, Randomized, Double blind, parallel-group, Placebo-controlledExploratory Efficacy and Safety Study ofSPD489 in Adults 18-55 years with MajorDepressive Disorder (MDD) as AugmentationTherapy to an Antidepressant·(Shire SPD489-203)ShireRaleigh, NCA Phase II, Multicenter Study with Open-labeland Randomized Double-blind Placebo Controlled Withdrawal Phases to Evaluate theEfficacy, Safety, and Tolerability of SPD489in Adults with Schizophrenia and PredominantNegative Symptoms Who Are ClinicallyStable and Taking Stable Doses of AtypicalAntipsychotic Medication(Shire SPD489-204)13
14
TABLE2RESEARCH STUDIES CLOSED ORDISCONTINUED IN 2009Sponsor I PITitle of Study I Clinical DrugTrial ProtocolJeremy S. Caldwell, Ph.D.High-Throughput Screening of Known Drugsfor Novel Biological Activity in Cell-basedAssaysGenomics Institute'N ovartis Research FoundationSan Diego, CAKaren Chang, Ph.D.ALZA CorporationMountain View, CAPurity Determination, Morphine andHydromorphoneArthur Cho, Ph.D.UCLALos Angeles, CAStudies on Distribution and MetabolismofNarcotics in AnimalsAlan Gevins, D. Sc.SAM TechnologySan Francisco, CAPanel Approved ResearchLorrin Koran, M.D.Stanford UniversityStanford, CADouble-Blind Trial of Acute &Intermediate-Tern Dextro-Amphetamineversus Caffeine Augmentation inTreatment-ResistantObsessive-Compulsive DisorderWalter Ling. M.D.UCLALos Angeles, CADouble-Blind, Placebo-Controlled Trial ofPrometa Pharmacotherapy for theTreatment of Methamphetamine Abuse15
Table 2 Cont.Sponsor I PITitle of Study I Clinical DrugTrial ProtocolJohn Polich, Ph.D.The Scripps Research InstituteLa Jolla, CAMarijuana CNS Effects in Low- andHigh-Risk AdultsSteven Shoptaw, Ph.D:UCLALos Angeles, CAA Randomized, Double-Blind,Placebo-Controlled Evaluation ofModafinil vs Placebo for the Treatment ofMethamphetamine DependenceAcelR.x PharmaceuticalsRedwood City, CAA Randomized, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate theClinical Efficacy, Safety, and Tolerabilityof ARX-F03 SublingualSufentanil/Triazolam Nanotabs in PatientsUndergoing an Elective AbdominalLiposuction Procedure(AcelRx ARX-C-004)BioDelivery Sciences International, Inc.Raleigh, NC'Open-Label, Long-Term Extension Studyfor Treatment of Breakthrough CancerPain with BEMA Fentanyl(BioDelivery FEN-290)Endo Pharmaceuticals, Inc.Chadds Ford, PAA Double-Blind, Randomized, Placebo Controlled, multicenter Study to Evaluatethe Efficacy and safety ofEN3267 for theTreatment of Breakthrough Pain in OpioidTolerant Cancer Patients Followed by a12-Month Non-Randomized, Open-labelExtension to Assess Long-Term Safety(Endo EN3267-005)16
Table 2 Cont.Sponsor I PITitle of Study I Clinical DrugTrial ProtocolEndo Pharmac uticals, Inc.Chadds Ford, PAA Multiple-Dose, Non Randomized,Open-Label, Multicenter Study toEvaluate the Long-Term Safety andEffectiveness ofEN3267 in the Treatmentof Breakthrough Pain in Cancer patients(Endo Protocol EN3267-007)Johnson & Johr}.sonAustin, TXA Randomized, Double-Blind, Active-andPlacebo-Controlled, Parallel-Group,Multicenter Study to Evaluate the Efficacyand Safety ofTapentadol Immediate Release Formulation in the Treatment ofAcute Pain from Bunionectomy(J&J R331333-PAI-3018)'Johnson & JohnsonCypress, CAA Pivotal Bioequivalence Study AssessingTransdermal D-TRANS Fentanyl 100uglh Matrix System to DURAGESICFentanyl 100 uglh Reservoir System AfterSingle Application in Healthy Subjects(J&J FEN-PAI-1019)'Johnson & JohnsonTitusville, NJA Randomized, Double-blind, Placebo and Active- Controlled, Parallel-arm,Multicenter Study in Subjects With End Stage Joint Disease to Compare theFrequency of Constipation Symptoms inSubjects Treated with Tapentadol IR andOxycodone IR Using a Bowel FunctionPatient Diaiy(J&J R331333-PAI-3020)17
Table 2 Cont.Sponsor I PITitle of Study I Clinical DrugTrial ProtocolN euromed PharmaceuticalsRaleigh, NCA Phase III, Variable-Dose TitrationFollowed by a Randomized Double-BlindStudy of Controlled-Release OROS Hydromorphone HCl (NMED-1 077)Compared to Placebo in Patients withChronic Low Back Pain(Neuromed NMT 1077-3 01)NextWave PharmaceuticalsResearch Triangle Park, 'NcNWP06 in Treatment of Children withADHD: A laboratory Classroom Study(NextWave NWP06-ADD-100)Ortho-McNeil Janssen Scientific Affairs,LLCRaritan, NJA Randomized, Double Blind, Placebo and Oxycodone Immediate Release (IR) Controlled Study of Tapentadol IR for theTreatment of Acute pain Caused byVertebral Compression Fractures. Associated with Osteoporosis'(OMJSA R331333-PAI-3021)A Multi-center, Randomized, Double blind, Placebo-controlled Study with anOpen-label Run-in to Assess the Efficacy,Tolerability, and Safety of BTDS 10 orBTDS 20 Compared to Placebo in Opioid naive Subjects with Moderate to Severe,Chronic Pain due to Osteoarthritis of theKnee(Purdue BUP3025)Purdue Pharma L.P.Stamford, CT18
Table 2 Cont.Sponsor I PITitle of Study I Clinical DrugTrial ProtocolShire Pharmaceuticals, Inc.Wayne, PAA Phase Illb, Randomized, Double-Blind,Multi-Center, Placebo-Controlled, Dose Optimization, Cross-Over, AnalogClassroom Study to Assess the Time ofOnset ofVyvanse in Pediatric Subjectsaged 6-12 Diagnosed with Attention Deficit/Hyperactivity Disorder(Shire SPD489-311)Shire Pharmaceuticals, Inc.Philadelphia, PAA Phase III Randomized, Double-Blind,Multicenter, Parallel-Group, Placebo Controlled, Forced-dose Titration, Safetyand Efficacy Study of LisdexamfetamineDimesylate (LDX) in Adolescents Aged13-17 with AttentionDeficit/Hyperactivity Disorder (ADHD)(Shire SPD 489-305)19
20
APPENDIX ACURRENTLY OPEN (through December 31, 2009)SCHEDULE I AND SCHEDULE IINON-HUMAN AND ACADEMIC HUMANRESEARCH STUDIESPrincipal InvestigatorTitle of StudyMark A. Agius, M.D.UC. DavisDavis, CACannabis for Spasticity/Tremor in MS:Placebo Controlled StudyDanilyn Angeles, Ph.D.Lorna Linda UniversityLorna Linda, CAA Double-blind randomized Clinical Trial onthe Use of Pre-emptive Morphine Infusion inAsphyxiated Term and Near-Term InfantsJames T. Arnold, Ph.D.Systems and Techniques Lab.Palo Alto, CAPanel Approved Research ProjectGayle C. Baldwin, Ph.D.UCLALos Angeles, CAMethamphetamine Dependence: A NovelLaboratory ModelMariusz G. Banaszczyk, Ph.D.Biosite DiagnosticsSan Marcos, CADevelopment ofln-vitro Immunoassays forthe Detection of Abused SubstancesSelena E. Barrett, Ph.D.Ernest Gallo Clinic & Research Ctr.Emeryville, CAThe role of cannabinoids and ibogaine in thetreatment of alcoholism and drug addictionNancy E. Buckley, Ph.D.California Stat Polytechnic Univ.Pomona, CA 91768The cannabinoid system and the modulation ofT cell and macrophage Functions21
Appendix A Cont.Principal InvestigatorTitle of StudyJohn R. Cashman, Ph.D.Human BioMolecular ResearchInstituteSan Diego, CAMolecular Evolution of Human CocaineCatalysisKent S. Chu, Ph.D.YJ Bio-ProductsCordova, CAImmunochromatographic Test Device forTHC and LSDLaura ColinBiostride, Inc.Redwood City, CAPanel Approved Research ProjectG. Patrick Dauert, M.D.UC Davis Medical CenterSacramento, CADoes Oral Methadone Use in OpiateReplacement Therapy Prolong the QTcInterval?Mohammad Diab, M.D.'UC San FranciscoSan Francisco, CAComparison of Extended-Release EpiduralMorphine, PC Epidural Analgesia, & PCIntravenous Analgesia for Post-Op PainManagement after Post. Spinal Fusion inAdolescentsRobert Edwards, M.D.UCSF School ofMediciheSan Francisco, CAPanel Approved Research ProjectAaron Ettenberg, Ph.D.UC Santa BarbaraSanta Barbara, CADopamine Involvement in Opiate andStimulant Drug Reinforcement22'---- --------- - ----- -- ---------- -------------------------
Appendix A Cont.Principal InvestigatorTitle of StudyFrederick D. Frankel, Ph.D.UCLAISAPLos Angeles, CASocial Skills Training for Medicated ChildrenGantt GallowaY,, Pharm.D.APRL/CPMC Research InstituteSan Francisco, CAPhase 1, Double-Blind, Placebo-ControlledAssessment of Potential Interactions BetweenIntravenous Cocaine and lofexidineJean Gehricke, Ph.D.UC IrvineIrvine, CAPanel Approved Research ProjectMark A. Geyer, Ph.D.UC San DiegoLa Jolla, CABehavioral and Cytofl.ourimetric Studies ofPsychoactive Drugs in RatsCharles S. Grob, M.D.Harbor UCLA Medical CenterTorrance, CA 'Effects of Psilocybin in Terminal CancerPatients with AnxietyKanthi F. Hettiarachchi, Ph.D.SRI InternationalMenlo Park, CAAnalysis of CannabinoidsScott A. Irwin, MD, PhDSan Diego Hospice/ Palliative CareSan Diego, CAPanel Approved Research ProjectThomas B. KingAlexza Molecular Delivery Corp.Palo Alto, CADevelopment of an FDA Approved· Dronabinol Pharmaceutical Product forInhalation Delivery23
Appendix A Cont.Principal InvestigatorTitle of StudyEdward T. Kisak, Ph.D.Fqubed, Inc.San Diego, CATransdermal Delivery of tetrahydrocannabinolGeorge F. Koob, Ph.D.The Scripps Research InstituteLa Jolla, CACentral Mechanisms of Opiate Reinforcementand DependenceLorrin Koran, M.D.Stanford University,School of MedicineStanford, CADouble-Blind Trial of Acute &Intermediate-Tern Dextro-Amphetamineversus Caffeine Augmentation inTreatment-Resistant Obsessive-CompulsiveDisorderKimberley D. Lakes, Ph.D.UC IrvineIrvine, CAThe Effects ofVyvanse on BrainHemodynamics and ReadingAdam Leventhal, Ph.D.USC Keck School of MedicineAlhambra, CAInfluence of Genes and Emotions onmedication EffectsLinghui Li, Ph.D.,APRL/CPMC Research InstituteSan Francisco, CAAn Open-Label Stud to Evaluate the Impact ofGenetic Variation in CYP2D6 on thePharmacokinetics and Pharmacodynamics ofMethamphetamine in Healthy AdultsMarie Lin, Ph.D. R.Ph.Lin-Zhi International, Inc.Sunnyvale, CALin-Zhi Immunoassay Development Study24'- ---- - - ---------- ---- - - - - - - - - -------- - ------
Appendix A Cont.Principal InvestigatorTitle of StudyEdythe London, Ph.D.UCLALos Angeles, CAA Study to Assess the Cardiovascular,Cognitive, and Subjective Effects ofAtomoxetine in Combination with IntravenousAmphetamineSean D. McAllister, Ph.D.CPMC Research InstituteSan Francisco, CAPanel Approved Research ProjectJames T. McCracken, M.D.UCLANPILos Angeles, CAAn 8-Week, Randomized, Double-BlindComparison of Twice-Daily Guanfacine,Once-Daily d-Methylphenidate ER (FocalinXR) and the Combination, with a 12 MonthOpen-Label Extension for the Treatment ofADHD in Pediatric Subjects Aged 7 to 14years ·John Mendelson., M.D.APRL/CPMC Research InstituteSan Francisco, CAIs There an Acute MDMA Single DoseWithdrawal Syndrome?John Mendelson, M.D.APRL/CPMC Research InstituteSan Francisco, CASteady State Kinetics of !-Methamphetamineand Validation of Sensitivity of DoseEstimationJohn Mendelson, M.D.APRL/CPMC Research InstituteSan Francisco, CABioavailability and Urinary Excretion of OralL-MethamphetamineJohn Mendelson, M.D.APRL/CPMC Research InstituteSan Francisco, CAInteractions ofPrazosin and MDMA25
Appendix A Cont.Principal InvestigatorTitle of StudyJohn Mendelson, M.D.APRL/CPMC Research InstituteSan Francisco, CAPilot Study of LSD in Healthy VolunteersJohn Mendelson, M.D.APRL/CPMC Research InstituteSan Francisco, CAClinical Pharmacology of3,4-methylenedioxyamphetamine (MDA)Robert Messing, M.D.Ernest Gallo Clinic & Research CtrEmeryville, CAProtein kinase C epsilon (PKCe) in Responsesto CannabinoidsStanley M. Parsons, Ph.D.UC Santa BarbaraSanta Barbara, CAPanel Approved Research ProjectRichard Reznichek, M.D.Harbor-UCLA Medical CenterTorrance, CAA prospective, randomized, double-blindstudy comparing the efficacy and safety ofintra nasal fentanyl spray to placebo as ananalgesic in patients undergoing outpatientcystoscopic proceduresMark Rollins, MD, PhDUCSF Dept of AnesthesiaSan Francisco, CASupplemental Oxygen: A Reduction in PulseOximetry Sensitivity or an Increased Marginof Safety?Dorit Ron, Ph.D.Ernest Gallo Clinic & Research CtrEmeryville, CASignaling Pathways Involved in theMechanism of Action of the Anti-AddictiveDrug Ibogaine26'------·------- ----·--·--·
Appendix A Cont.Principal InvestigatorTitle of StudyMatthew A. Schreiber, M.D., Ph.D.Ernest Gallo Clinic & Research CtrEmeryville, CAPharmacological and genetic study of theeffects of3,4 methylenedioxymethamphetamine (MDMA)using a model organism, the nematodeCaenorhabditis elegansLawrence Toll, Ph.D.SRI InternationalMenlo Park, CABiochemical Studies into Opiate EfficaciesStephen Van Dien, Ph.D.Genomatica, Inc.San Diego, CAPanel Approved Research ProjectMark Wallace, M.D.UC San DiegoSan Diego, CAEfficacy of Inhaled Cannabis for theTreatment of Painful Diabetic PeripheralNeuropathyJennifer L. Whistler, Ph.D.Ernest Gallo Clinic & Research Ctr.Emeryville, CAEndocytosis and Cannabinoid ReceptorsJennifer L. Whistler, Ph.D.Ernest Gallo Clinic & Research Ctr.Emeryville, CA;Endocytosis and Opioid ReceptorsTimothy Wigal, Ph.D.UC IrvineIrvine, CABrain Dopamine Function in Adults withAttention Deficit/Hyperactivity Disorder(ADHD)Barth Wilsey, M.D.UC Davis Medical CenterSacramento, CAThe Analgesic Effect of Vaporized Cannabison Neuropathic Pain27
Appendix A Cont.Principal InvestigatorTitle of StudyRandall WongNorac Pharma, Inc.Azusa, CAPanel Approved Research ProjectRandall WongN orac Pharma, Inc.Azusa, CAPanel Approved Research Project28·-·---------------- -------
APPENDIXBCURRENTLY OPEN (through December 31, 2009)SCHEDULE II CLINICAL DRUG TRIAL STUDIESDescription or Titleof Clinic
San Francisco, CA . Edythe London, Ph.D. , UCLA Los Angeles, CA . John E. Mendelson, M.D. APRL/CPMC Research Institute San Francisco, CA . John E. Mendelson, M.D. APRL/CPMC Research Institute San Francisco, CA . Table 1 Cont. Title of Study I Clinical Drug Trial Protocol . Pilot Trial of Bupropion versus Placebo for Methamphetamine Abuse in .
