Emerging Issues in the Crisis

Nora D. Volkow, M.D. Director

National Institute on Drug Abuse

@NIDAnews Overdose Deaths in 2019 Increased by 4.6%

Number of Deaths Number of Deaths

40,000 , 37,137 18,000 Prescription , 14,347 Methamphetamine, 16,539 35,000 16,000 , 14,278 Cocaine, 16,196 30,000 14,000

12,000 25,000 10,000 20,000 8,000 15,000 6,000 10,000 4,000

5,000 2,000

0 0 Overdose Death Rates: Other Synthetic Narcotics (Including Illicit Fentanyl)

2013 2018

Source: CDC WONDER. Age-adjusted death rates per 100,000. Overdose Death Rates: Psychostimulants With Abuse Potential (Including Methamphetamine)

2013 2018

Source: CDC WONDER. Age-adjusted death rates per 100,000. Intersection Between Opioid Crisis and COVID-19

` Overdoses Grew Dramatically During COVID Pandemic

ST Drug Use Increase During COVID

Total US Increase 31.96%

19.96%

10.06% 12.52%

7 Millennium Health Signals Report™ COVID-19 Special Edition: Significant Changes in Drug Use During the Pandemic Volume 2.1 | Published July 2020

Total Study Population Change in Unadjusted Positivity Rate for Cocaine, Fentanyl, Heroin and Methamphetamine COVID-Related Policy Changes for Prescribing Medications for OUD Prior to COVID: Prior to COVID: • Only federally-approved opioid • Prescribed through pharmacies in outpatient treatment programs settings • In-person for daily dosing • DATA 2000, limited to clinicians with bup. waivers that required additional training and Under COVID, SAMSHA allowed: federal registration • 3/16/2020: 28 day take home • Limited number of patients to treat • 3/20/2020: for those under • In-person evaluation for initial dose quarantine—surrogate take home or door-step delivery Under COVID, DEA allowed: • Still requires in person visit for first • 3/17/2020: Buprenorphine initiation through dose telehealth (including phone) without in- person visit • Follow up can be via phone Additional Opportunities in SUD Treatment Under COVID

• Increased use of telemedicine and its reimbursement Expanded access to treatment of co-morbid conditions Expanded access to behavioral treatments Establishment of mental health hot lines Deployment of virtual support meetings and coaches

• Changes in justice settings Release of non-violent offenders with SUD from jails/prisons Expanded use of telemedicine including for medications for OUD Expanded opportunities for education via web-based program U.S. Drug-Involved Overdose Deaths, by Race

30 AI/AN (NH), 27.0 25 White (NH), 25.7

Black (NH), 21.1 20 U.S. , 20.7

15

Hispanic, 11.0

10

Adjusted Rate/100K Population Rate/100K Adjusted - 5 Age Asian or PI (NH), 3.7

0

Includes all underlying causes of death: unintentional, intentional and undetermined. Medications Currently Available For Nicotine • Nicotine Replacement Therapies (NRT) • Bupropion • Varenicline

For Alcohol Use Disorder • Disulfiram • • Acamprosate

For Opioid Addiction • Methadone • Naltrexone • Buprenorphine Stimulant (cocaine and methamphetamine) Use Disorder Medication Pipeline Black – NME Red – New Indication Blue – Biologic Green – Gene Therapy * cocaine + meth * + cocaine or meth

Early Preclinical Late Preclinical Ph I Ph Ib Ph II Ph III T2L: (>12 yrs) (10-12 yrs) (6-10 yrs) (5-9 yrs) (4-6 yrs) (3-5 yrs) SBI-0069330 or GLT-1 up-regulator * Orexin-1 dAdGNE * * NS2359 * Mavoglurant * SBI-0801315 * + antagonist * Anti-cocaine vaccine NE/5HT antagonist DAT/NET/SERT inhib. mGluR5 mGluR2 PAM non-competitive antagonist

NOP/Kappa/Mu Meth vaccine + IXT-m200 + Cocaine hydrolase Duloxetine & Bupropion * Lorcaserin * ligands * Long-duration gene therapy * Methylphenidate + DAT/NET inhibitor anti-meth mAb NET/SERT inh. & CNS stim.

PTPRD ligands * + Cocaine hydrolase * Methamphetamine h2E2 * Lorcaserin * Adderall * EMB-001 * Conjugate Vaccine Anti-cocaine mAb 5-HT2C agonist Mixed amph. salts Metyrapone/oxazopam GC synth inhib/benzo.

Peptidic KOR agonists * VMAT-2 inhibitor + Cariprazine * * Guanfacine * D3/D2/5HT1A partial NMDA antag. α2A agonist agonist

Pomaglumetad IXT-m200 + methionil + Anti-meth mAb mGluR2/3 agonist prodrug

Clavulanic acid * GLT-1 activator An Effective but Inaccessible Methamphetamine Treatment: Contingency Management (CM) Opportunity Challenges • CM is a behavioral treatment in • Treatment programs receiving which behavioral change targets federal funds are allowed to (such as drug abstinence) are set award a maximum of and carefully monitored, and $75/patient/year rewards are issued for • More is disallowed by HHS compliance under anti-kickback statute • Meta-analyses indicate that CM • Legal concerns have is the most effective behavioral disincentivized uptake of CM treatment for stimulant • Effective CM protocols provide addiction more than $75 • range ~ $200-$2000

NIDA-Supported COVID Policy Research •How does telehealth access affect OUD treatment, including in rural settings? •What is the impact of methadone take home dose policy on treatment retention/adherence and drug use? •How has the pandemic affected syringe service programs, including distribution and medication enrollment? •Effects of state marijuana laws and COVID-related stress on marijuana use? •How have COVID-related substance use policy changes been disseminated, adopted, and implemented within Tribal communities? HEALing Communities Study Justice Community Opioid Innovation Network

18 States + PR 88 communities >25,000 justice- involved persons

• Has the rate of overdoses changed? • Compiled >120 guidelines/resources for justice • Impact on treatment initiation and retention systems responding to COVID-19 • Impact on drug access in the community • Advisory group to provide real-time information • Challenges to providers and first responders to NIDA on COVID-19 impact in justice settings • Challenges to those with SUD 16 Structural Challenges for SUD During COVID-19

• Stress • Stigma • Access to medications for OUD • Limited access to peer-support groups or other sources of social Buffalo NY Methadone Clinic connection March 2020 • Social distancing increases likelihood of opioid overdoses happening with no observers who can administer naloxone