CRAN Joint Council Meeting May 3 2017 Nora D Volkow MD Director NIDAnews National Institute on Drug Abuse Division of Therapeutics and Medical Consequences Center for the Clinical Trials Network ID: 612630
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NIDA Director’s Report to the
CRAN Joint Council Meeting
May 3, 2017
Nora D. Volkow, M.D.
Director
@
NIDAnews
National Institute
on Drug AbuseSlide2
Division of Therapeutics and Medical Consequences
Center for the Clinical Trials Network
Division of
Epidemiology, Services and Prevention Research
Office of the Director
Office of Diversity & Health Disparities
Office of Translational Initiatives and Program Innovations
Division of Neuroscience and Behavior
Office of
Management
Office of
Science Policy &
Communications
Intramural
Research
Program
Division of
Extramural
Research
International Program
AIDS Research Program
NIDA
Dr. Rita Valentino
Phil Skolnick, PhD
Director
LEFT FOR A JOB IN INDUSTRYSlide3
2016 Monitoring the Future Study
Key Findings- Prevalence (2015 to 2016)DRUG USE IN TEENAGERS IS GOING DOWN Slide4
WHAT IS DRIVING DECREASES IN DRUG
USE IN TEENAGERS?Slide5
Workshop: Social Media, Mobile Technology and Youth Risk Behaviors
TBD Fall 2017
The workshop will convene a small group of innovative thinkers from academia and industry to discuss opportunities and methodological challenges in studying how youth behavior is affected by social media engagement.Slide6
ABCD UpdateABCD Study Announces Fast Track Data release -
SPRING 2017 https://data-archive.nimh.nih.gov/abcdThis inaugural data release contains unprocessed neuroimaging data from 2000 participants, aged 9-10 years old, as well as basic participant demographics (age, sex), including:
High-resolution structural data (3D T1 - and T2-weighted scans)
Advanced diffusion MRI (multiple b-values and directions)Resting State fMRITask fMRI (Monetary Incentive Delay, Stop-Signal, and Emotional N-Back), along with raw E-Prime task files
Dr. Gaya Dowling will be presenting
a more comprehensive update
later today…Slide7
2015 Overdose Deaths:
52,404 Any Drug
33,091 Any Opioid
Opioid OD Deaths US
,
2000-2015Source: IMS Health, U.S. Outpatient Retail Setting
Opioid morphine milligram equivalents (MME) dispensed fell by over 15% from 2010-2015Opioid prescriptions have started to Decrease but Opioids Fatalities are still IncreasingSlide8
Heroin Price Has Decreased in Recent Years
National Drug Control Strategy--Data Supplement 2014. https://www.whitehouse.gov/sites/default/files/ondcp/policy-and-research/ndcs_data_supplement_2014.pdf
Emerging Illicit Synthetic Opioids
Increasing reports of fentanyl laced-heroin and prescription pillsOther synthetic opioids emerging i.e., CarfentanilSlide9
PAIN MANAGEMENT
Safe, more effective strategies
OPIOID ADDICTION TREATMENT
New and innovative medications and technologiesOVERDOSE REVERSAL
Interventions to reduce mortality and link to treatment
Using Research to End the Opioid Crisis
NIH OPIOID RESEARCH INITIATIVESlide10
The Case for a Public-Private Partnership on Development of Non-Addictive Pain MedicinesUrgent public health crisis
Absence of highly potent alternatives to opioids – market failure?Emergence of numerous potential drug targetsPossibility of development and validation of biomarkers for pain Strong support at the highest level of U.S. GovernmentFDA participation will be criticalPotential for additional industry incentivesSlide11
Medications Development for Opioid Use Disorders and for Overdose Prevention and Reversal
Date: June 5, 2017Goal: To stimulate innovative directions in preventing and treating opioid
use disorders and overdoses
Key Topics:Opioid-based targetsNon-opioid-based targets
Biologics (e.g., vaccines, monoclonal antibodies)
Overdose treatment
Challenges posed by synthetic opioidsNon-pharmacological treatments
Cutting Edge Science Meeting Series to End the Opioid Crisis
1Slide12
Development of Safe, Effective, Non-Addictive Pain Treatments
Date: June 16, 2017 Goal: To expedite development of medications to treat chronic pain with little or no potential for misuse or addiction.
Key Topics:
Molecular Libraries for Screening AnalgesicsNovel or re-Purposed Agent Profiles and Mechanisms of Action (e.g. Biased Agonists, Peripheral agonists, Heteromers
, Mixed opioid receptor targets) New Analgesic Development (opioid and non-opioid)
Genetic data on pain sensitivity
Other treatment modalitiesBiomarkers
Cutting Edge Science Meeting Series to End the Opioid Crisis
2Slide13
Understanding the Neurobiological Mechanisms of Pain
Date: July 7, 2017Goal: To enhance our understanding of the neurobiological mechanisms of pain to accelerate the development of novel pain treatments Key Topics:
Pain Neural Circuitry and Maladaptive Plasticity
Pain and Immune FunctionAcute-to-chronic pain transition
Heterogeneity of pain syndromes
Cutting Edge Science Meeting Series to End the Opioid Crisis
3Slide14
RFA-CA-14-008/009:
Using Social Media to Understand and Address Substance Use and AddictionA CRAN Initiative
Activity Summary
June 10, 2015: Grantee Introduction Webinar
June 22-23, 2016: Grantee Meeting
2016 Society of Prevention Research Panel
3 R21s [completed 2016], 8 R01s [in last year]34 papers produced alreadyA nice start to a new area of scienceSlide15Slide16
Chair:John
CarnevaleMembers:Ken Mackie
Rosalie Pacula
Jonathan Caulkins
Mark WareStu Gitlow
Deborah Hasin
NIDA staff involved:
Katia Howlett
Steve
Gust
Marsha Lopez
NIDA has launched a new
Council Workgroup on Policy Research
Related to Cannabis Legalization
Purpose:
to provide advice and guidance to NIDA on critical research questions/priority areas related to the changing legal landscape for cannabis. Slide17
Hospital Discharges and Poison Center Calls
Davis et al. Am J Prev Med 2016;50(3):373–379.
Public Health Effects of Medical Marijuana Legalization in ColoradoSlide18
Cannabinoid Receptors Are Located Throughout the Brain
Regulation of:
Brain Development
Memory and Cognition
Movement Coordination
Pain Regulation
& Analgesia Immunological Function
Appetite
Motivational Systems
& RewardSlide19
Targeting the Cannabinoid System for Therapeutic Purposes
Exogenous compoundsPhytocannabinoids
THC, CBD, combinationsSynthetic cannabinoids
DronabinolEndogenous manipulationFAAH inhibitors
MAGL inhibitorsAllosteric modulators
Receptor targetsCB1, CB2, TRPV1, PPAR, 5-HT, peripheral, others…Slide20
Strongest Evidence
Nausea (Cancer chemotherapy) Spasticity & Pain (MS)
Appetite Stimulant (AIDS-associated
wasting)
Pain esp. neuropathic
Glaucoma (decreases intraocular pressure; no evidence it slows
disease progression; & short acting)
Strength of the Evidence For
Marijuana/Cannabinoid
Medical Applications
Modest Evidence
Anticonvulsant (CBD)
Anti-inflammatory (CBD)
Antitumor (THC/CBD)
(animal models/cell
cultures: glioblastoma;
breast cancer cells;
others (mechanisms:
apoptosis; inhibition of
tumor angiogenesis)
Weakest Evidence
PTSD
ADHD
Alzheimer’sDepression Slide21
Cannabinoids for Addiction TreatmentCBD has anti-addiction properties in animal models
Reduces heroin seeking behaviorReduces morphine withdrawal symptomsPreliminary evidence for therapeutic benefit in humansNabiximols (THC/CBD) reduced cannabis withdrawal symptoms and increased treatment retention
CBD reduced cravings for heroinCBD can mitigate the negative health effects
of some drugs (e.g. cocaine effects on liver)CBD reduced number of cigarettes consumed by active smokers
CBD reduced withdrawal symptoms and cravings for cannabis
Hurd, et al. 2015; Allsop
, et al. 2014Slide22
Barriers to Marijuana Research Significant administrative and regulatory burden for research on marijuana:
The Schedule I registration process can take more than a year to complete Time consuming protocol review, and re-review for protocol
changes
Separate registrations for each Schedule I compound CBD still Schedule I despite lack of abuse potential
Inability to access marijuana from state dispensaries for
research Slide23
This documentary portrays an emotional description of opioid addiction through the eyes of families who have lost loved ones, or who are struggling to help family members
NIDA has worked with HBO on this hour long documentary and has helped them build an online resource page
to offer more information on MAT and evidenced based treatment
Premiers May 1, 2017 at 10 PMhttp://www.hbo.com/documentaries/warning-this-drug-may-kill-you/video/promo