NIDA Director’s Report to the
CRAN Joint Council Meeting
May 3, 2017
Nora D. Volkow, M.D.
Director
National Institute
on Drug Abuse
@NIDAnews
NIDA
Office of Diversity &
Health Disparities
Office of the
Director
Office of Translational
Initiatives and Program
Innovations
Office of
Management
Center for the Clinical
Trials Network
AIDS Research Program
International Program
Office of
Science Policy &
Communications
Division of Therapeutics
and Medical
Consequences
Intramural
Research
Program
Division of Neuroscience
and Behavior
Division of
Extramural
Research
Division of
Epidemiology, Services
and Prevention Research
Dr. Rita Valentino
Phil Skolnick, PhD
Director
LEFT FOR A JOB IN
INDUSTRY
2016 Monitoring the Future Study
Key Findings- Prevalence (2015 to 2016)
DRUG USE IN TEENAGERS IS GOING DOWN
WHAT IS DRIVING DECREASES IN DRUG USE IN TEENAGERS?
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.
ABCD Update
ABCD Study Announces Fast Track
Data release - SPRING 2017
ABCD Enrollment
through April 30, 2017
Number of Participants
2500
2302
2000
1837
1500
1380
1000
1016
672
500
0 0
428
59
197
Dr. Gaya Dowling will be presenting
a more comprehensive update
later today…
https://data-archive.nimh.nih.gov/abcd
• This 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 bvalues and directions)
• Resting State fMRI
• Task fMRI (Monetary Incentive Delay,
Stop-Signal, and Emotional N-Back),
along with raw E-Prime task files
Opioid prescriptions have started to Decrease but
Opioids Fatalities are still Increasing
Opioid morphine milligram
equivalents (MME) dispensed fell
by over 15% from 2010-2015
300
OPIOID MME IN BILLIONS
266
260
253
250
242
234
222
200
150
100
50
0
2010
2011
2012
2013
2014
2015
Source: IMS Health, U.S. Outpatient Retail Setting
Opioid OD Deaths US, 2000-2015
2015 Overdose Deaths:
52,404 Any Drug
33,091 Any Opioid
Heroin Price Has Decreased
in Recent Years
Emerging Illicit Synthetic Opioids
"Retail" Price Per
Pure Gram
$3,500
$3,000
$2,500
$2,000
$1,500
$1,000
$500
$-
National Drug Control Strategy--Data Supplement 2014.
https://www.whitehouse.gov/sites/default/files/ondcp/policy-andresearch/ndcs_data_supplement_2014.pdf
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Increasing reports of fentanyl laced-heroin
and prescription pills
Other synthetic opioids emerging i.e.,
Carfentanil
NIH OPIOID RESEARCH INITIATIVE
Using Research to End the Opioid Crisis
PAIN MANAGEMENT
Safe, more effective strategies
OPIOID ADDICTION
TREATMENT
New and innovative
medications and technologies
OVERDOSE REVERSAL
Interventions to reduce
mortality and link to
treatment
The Case for a Public-Private Partnership on
Development of Non-Addictive Pain Medicines
• Urgent public health crisis
• Absence of highly potent alternatives to opioids –
market failure?
• Emergence of numerous potential drug targets
• Possibility of development and validation of biomarkers
for pain
• Strong support at the highest level of U.S. Government
– FDA participation will be critical
– Potential for additional industry incentives
Cutting Edge Science Meeting Series to
End the Opioid Crisis
1
Medications Development for Opioid Use Disorders and
for Overdose Prevention and Reversal
Date: June 5, 2017
Goal: To stimulate innovative directions in preventing and treating opioid
use disorders and overdoses
Key Topics:
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Opioid-based targets
Non-opioid-based targets
Biologics (e.g., vaccines, monoclonal antibodies)
Overdose treatment

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Challenges posed by synthetic opioids
Non-pharmacological treatments
Cutting Edge Science Meeting Series to
End the Opioid Crisis
2
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 Analgesics
Novel 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 modalities
Biomarkers
Cutting Edge Science Meeting Series to
End the Opioid Crisis
3
Understanding the Neurobiological Mechanisms of Pain
Date: July 7, 2017
Goal: 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 Function
 Acute-to-chronic pain transition
 Heterogeneity of pain syndromes
RFA-CA-14-008/009:
Using Social Media to Understand and
Address Substance Use and Addiction
A CRAN Initiative
Activity Summary
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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 already
A nice start to a new area of science
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.
Chair:
John Carnevale
Members:
NIDA staff involved:
Ken Mackie
Rosalie Pacula
Jonathan Caulkins
Mark Ware
Stu Gitlow
Deborah Hasin
Katia Howlett
Steve Gust
Marsha Lopez
Public Health Effects of Medical Marijuana
Legalization in Colorado
Hospital Discharges and Poison Center Calls
Davis et al. Am J Prev Med 2016;50(3):373–379.
Cannabinoid Receptors Are Located
Throughout the Brain
Regulation of:
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Brain Development
Memory and Cognition
Movement Coordination
Pain Regulation
& Analgesia
Immunological Function
Appetite
Motivational Systems
& Reward
Targeting the Cannabinoid System for
Therapeutic Purposes
• Exogenous compounds
• Phytocannabinoids
• THC, CBD, combinations
• Synthetic cannabinoids
• Dronabinol
• Endogenous manipulation
• FAAH inhibitors
• MAGL inhibitors
• Allosteric modulators
• Receptor targets
• CB1, CB2, TRPV1, PPAR, 5-HT, peripheral,
others…
Strength of the Evidence For Marijuana/Cannabinoid Medical Applications
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)
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
•
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PTSD
ADHD
Alzheimer’s
Depression
Cannabinoids for Addiction Treatment
•
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CBD has anti-addiction properties in animal models
• Reduces heroin seeking behavior
• Reduces morphine withdrawal symptoms
Preliminary evidence for therapeutic benefit in
humans
• Nabiximols (THC/CBD) reduced cannabis
withdrawal symptoms and increased
treatment retention
• CBD reduced cravings for heroin
• CBD 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
Hurd, et al. 2015; Allsop, et al. 2014
for cannabis
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
Premiers May 1, 2017 at 10 PM
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http://www.hbo.com/documentaries/warning-this-drug-may-kill-you/video/promo
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