Kevin Walton, Ph.D. Chief, Clinical Research Grants Branch Division - - PowerPoint PPT Presentation

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Kevin Walton, Ph.D. Chief, Clinical Research Grants Branch Division - - PowerPoint PPT Presentation

Mar 29, 2023 126 likes •275 views

Kevin Walton, Ph.D. Chief, Clinical Research Grants Branch Division of Therapeutics and Medical Consequences NIDA No disclosures NIDA Organizational Chart Office of Diversity & AIDS Research Health Disparities Office of Program Office of

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Kevin Walton, Ph.D.

Chief, Clinical Research Grants Branch Division of Therapeutics and Medical Consequences NIDA No disclosures

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NIDA Organizational Chart

Office of Diversity & Health Disparities Office of Translational Initiatives & Program Innovations Division of Therapeutics and Medical Consequences Center for the Clinical Trials Network Division of Epidemiology, Services and Prevention Research Division of Neuroscience and Behavior Office of Management Science Policy & Communications Division of Extramural Research Intramural Research Program International Program AIDS Research Program Trans‐Division Research Teams

Office of the Director

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  • 1. Basic Science: Identify the biological, environmental, behavioral, and social

causes and consequences of drug use and addiction across the lifespan.

  • 2. Prevention: Develop new and improved strategies to prevent drug use and

its consequences.

  • 3. Treatment: Develop new and improved treatments to help people with

substance use disorders achieve and maintain a meaningful and sustained recovery.

  • 4. Public Health: Increase the public health impact of NIDA research and

programs.

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2016 Monitoring the Future Study

Key Findings‐ Prevalence (2015 to 2016)

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Steady Decline in Past Month Cigarette Use

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Teens more likely to use e‐cigarettes than combusted cigarettes

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Adult E‐cigarette Use

  • Population Assessment of Tobacco and Health (PATH)

– Longitudinal, comprehensive effort documenting tobacco use – 45,971 adults and youths, 12 years of age or older

  • Current use ‐ daily or some days (weighted percentages)
  • Based on US population numbers (Census bureau)

– About 37 million use cigarettes daily – About 3 million use e‐cigarettes daily

18‐24 yo >25 yo 18‐24 yo (DAILY) >25 yo (DAILY)

Cigarette 19.6% 17.9% 14.7% 16.2% E‐cigarette 8.9% 5.0% 1.3% 1.2%

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Questions About E‐cigarettes

How safe are they? Are they addictive? Are they a gateway to smoking? Do they have a role for harm reduction and cessation? What are the issues for vulnerable populations: youth, mental illness, pregnancy?

How to answer these questions?

  • Often requires preclinical and clinical studies.
  • Need devices with known aerosol / delivery characteristics.
  • Clinical studies often need FDA review, requiring a detailed

data package describing the device.

  • Uncertain availability of a commercial device thru a study.
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How is NIDA facilitating e‐cigarette research?

  • In 2014, NIDA issued a contract solicitation (SBIR) to develop a

Standardized Research E‐Cigarette (SREC) with an associated data package.

  • Four companies received Phase 1 contracts, NJOY LLC will be the first

to complete Phase 2.

  • Devices and refills will be available by 4Q 2017.
  • NJOY will sell the SREC directly to researchers together with

permission to reference the data package for FDA submissions.

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Key features of the SREC

  • E‐liquids made under GMP‐like conditions (to allow use in

clinical studies).

  • Fully characterized e‐liquid and aerosol.
  • Tobacco flavor, nicotine‐containing and placebo e‐liquids.
  • Unique battery connector and sealed cartridges limit use to

the characterized e‐liquid.

  • Reproducible aerosol delivery from start to end of cartridge &

battery charge.

  • Demonstrated nicotine delivery (pharmacokinetics).
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Technical Characteristics

  • 1. https://www.drugabuse.gov/funding/supplemental‐information‐nida‐e‐cig
  • 2. 2016 El‐Hellani et al, Nicotine and Carbonyl Emissions From Popular Electronic Cigarette Products:

Correlation to Liquid Composition and Design Characteristics. Nic Tob Res

SREC

1

COMMERCIAL

2

E‐LIQUID Puffs (3 s) per Cartridge > 350 Variable Nicotine Concentration 15 mg/mL 7‐21 mg/mL AEROSOL CHARACTERISTICS (per 10 puffs) Nicotine 1 mg 0.3 – 3 mg Formaldehyde 1 μg 0.6 ‐ 5 μg Acetaldehyde 0.9 μg 0.4 – 21 μg Acrolein 0.2 μg ? – 1.4 μg

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Nicotine Pharmacokinetic Profile

(mean ± SD)

t‐Test: Paired Two Sample for Means Cmax (ng/mL) Own SREC Mean 11.08 17.68 Variance 71.31 306.69 Observations 14 14 P(T<=t) two‐tail 0.21 t‐Test: Paired Two Sample for Means Tmax (min) Own SREC Mean 9.07 5.71 Variance 42.69 0.99 Observations 14 14 P(T<=t) two‐tail 0.06

Tmax (min) Cmax (ng/ml)

Own SREC 11.08 17.68 71.31 306.69 14 14 0.21 Own SREC 9.07 5.71 42.69 0.99 14 14 0.06

64 32 16 8 4 2 1 0.5 0.25 0 50 100 200 300 400 500

Own Device SREC

TIME (min)

Ad lib use Defined use

NICOTINE IN PLASMA

(ng/ml)

Cmax

Own Device SREC

Mean (ng/ml) 11.08 17.68 Variance 72.71 306.69 Observations 14 14 P(T<=t) two‐tail 0.21

Tmax

Own Device SREC

Mean (ng/ml) 9.07 5.71 Variance 42.69 0.99 Observations 14 14 P(T<=t) two‐tail 0.06

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Harm Reduction is the current focus

  • These studies with tobacco products are reviewed by the FDA

Center for Tobacco Products (CTP).

− We expect a complete SREC Product Master File will support the device’s use as an Investigational Tobacco Product.

Smoking/Nicotine Cessation studies are a future goal

  • This is a therapeutic indication, regulated by the FDA Center for

Drug Evaluation and Research (CDER).

− Investigational New Drugs require evidence of safety in animals prior to “First in Human” studies.

Overall Research Direction