Update on Addictions

George Kolodner, MD DLFAPA FASAM

Chief Clinical Officer

Kolmac Outpatient Recovery Centers

Clinical Professor of Psychiatry

Georgetown University and University of Maryland Schools of

Medicine

Overview

• Recent Use Patterns

• Relapse Prevention

• Specific Substances

Technology

32

2317 15

11 9 95 4

0

5

10

15

20

25

30

35

Percentage of People Addicted After Using A Substance

• Nicotine: 50 – 67%

– Predictors of progression from use to addiction:

• Unmarried female, lower age

• Anxiety disorder and absence of depression

• Cannabis: 17 – 25%

• Alcohol: 16%

– Predictors of progression from use to addiction:

• Unmarried male, nicotine addiction with lower age, income, and education

• Depression but not anxiety disorder

Risk of Addiction: Weekly Users

Substance Use by Teenagers, 2016(www.monitoringthefuture.org)

• Declines for most substances– Historic lows for alcohol, tobacco, heroin, inhalants– Decreased stimulants, MDMA (“ecstasy”), cocaine

• Cannabis – 8th graders: decreased

– 10th and 12th graders: no increase– Continued decline for synthetic cannabis (“K-2,” "Spice")

• Prescription opioids decreased

• Electronic cigarettes declined for first time– Exceed conventional cigarettes

2015 Substance Use Trends: College Aged (www.monitoringthefuture.org)

• Reduction in almost all substances

– Alcohol: reduced regular and binge

• Still common

– Tobacco: non-students > students

• Shift to electronic vaporizers

– Pain pills continue to decline (peaked in 2006)

– Stimulants: prescription and non-prescription including MDMA (“ecstasy”)

• Cannabis: increased but daily use is still below 2014 peak

Changes in Substance Useby Kolmac Patients

1989 2016

Cocaine 44% 9%

Opioids 6% 33%

Marijuana 6% 18%

Benzodiazepines 2% 8%

RELAPSE PREVENTION

Treating Relapsing Patients at Kolmac

• Philosophy

– SUD as chronic illness

– Importance of continuity

• Program design

• Patients

– Co-occurring psychiatric issues

– Total: 302

• Response

– Patients

– Insurance companies

Relapse Triggers: Neurotransmitters and Location

1. Exposure to the substance– Dopamine and endorphin

– Prefrontal cortex, nucleus accumbens, ventral pallidum

2. Drug associated cues (“People, places, and things”)– Dopamine, glutamate, and endorphin

– Prefrontal cortex, amygdala, anterior cingulate gyrus

3. Stress– Corticotropin-releasing factor (CRF), norepinephrine

– Bed nucleus of the stria terminalis

Opioids and Stress

• Addictive use of opioids creates persistent disruption of hypothalamic-pituitary-adrenal stress system

– Abstinence: Hyper-responsive

– Heroin: Hypo-responsive

– Methadone: Normal

Reducing Stress Induced Relapses

• Withdrawal from opioids and alcohol is associated with excessive norepinephrine activity in the brain stem (locus coereleus)

– Cause acute anxiety and agitation

– Cause longer lasting sensitivity of stress regulating system

• Alpha-2 adrenergic agonists moderate the excessive NE activity and relieve withdrawal

– Clonidine, Tenex (guanfacine)

• New: longer term use of alpha-2 agonists to disconnect stress pathway to reduce relapse

TOBACCO

FDA Regulations Regarding Tobacco Addiction Treatment

• Removed black box psychiatric warning on varenicline (Chantix)

E-Cigarettes (“Vaping”)

• Alternative nicotine delivery system

• Liquid is heated in a battery operated device that creates an aerosol that is inhaled– Not actually a vapor, but rather fine particles

• Liquid contains nicotine, flavoring, and other ingredients– No uniformity of product content

• “Mom and pop” stores make own mixtures

– Heating ingredient creates byproducts• Propylene glycol propylene oxide (carcinogen)

Youth: Shifting From Tobaccoto E-Cigarettes

Year Tobacco E-Cigarettes

2015 9% 16%

2011 16% 1.5%

Concerns About Use by Youth

• Some teens are starting with e-cigarettes and transitioning to regular tobacco

• NIDA: new project underway for prospective study of the effect of all substances on adolescent brain and cognitive development

– Baseline studies being done of 9 and 10 year old's, including MRIs

E-Cigarettes: Recent Developments

• New FDA regulations extends 2009 tobacco regulations to e-cigarettes, cigars, hookah and pipe tobacco

– No sales to youth younger than 18

– Ingredients examined for health impact

• Entry into the field by tobacco industry

• Devices are being used for illicit substances

• Increase in use is slowing

E-Cigarettes: Future Directions

• Can be useful for some people who are using them to quit tobacco

• Increase in harm reduction consideration

– “Dangers exaggerated”

CANNABIS (AKA MARIJUANA)

Latest Studies on Use

• Increase in number of use by young adults and older adults but not in teenagers, despite liberalization of cannabis laws

• Dramatic reduction in use of synthetic cannabinoids (spice, K2) as a result of

– Increased enforcement of laws

– Increased awareness of negative effects

Negative Effects onDeveloping Nervous System

• Heavy cannabis use

– Prospective study of 1,000 from birth to 38 found cognitive deficits if heavy use began before age 18

• IQ (8 points, no recovery)

• Attention (poor recovery)

• Memory, processing speed, reasoning skill

• In utero

– Decreased head circumference

– Cognitive and behavioral effects after age 4

– Colorado: increase in babies born with THC in their systems

Availability of Cannabis for Research

• Failure of Congressional bill to create new Schedule “1R” for cannabis research

• DEA:– Rejected changing Schedule 1 status for cannabis

– Will allow multiple suppliers for research grade production but as of now there is only a single supplier

• NIDA is working with the DEA to reduce the administrative burdens on research– CBD will be available for research studies

Expanded Research

• NIH Cannabis Neuroscience Research Summit, March 22-23, 2016

– Recording of conference available at: https://videocast.nih.gov/summary.asp?Live=18464&bhcp=1

• More balanced approach at American Society of Addiction Medicine Annual Meeting

Raphael Mechoulam

• 86 y.o. Israeli chemist, still professionally active

• Identified THC as the primary psychoactive ingredient in cannabis

• Discovered the endocannabinoid system

• “The Scientist”: YouTube documentary about his discoveries

– https://www.youtube.com/watch?v=csbJnBKqwIw

Pharmaceutical: “Entourage Effect”

• Sativex (1:1 ratio of CBD/THC)– Oro-mucosal spray

– Approved in 25 countries (2005) for spasticity from multiple sclerosis, cancer pain, neuropathic pain

– U.S.: Phase III clinical trials, fast tracked by FDA in April, 2014

• Epidiolex (cannabidiol or CBD)– Purified liquid extract

– Anticonvulsant for Dravet syndrome

– Orphan Drug Status from FDA, pre-IND

Efficacy of Medical Cannabis

• High quality evidence– Chemotherapy-induced nausea and vomiting– Appetite stimulation– Chronic pain, neuropathic (especially HIV/AIDS)– Spasticity of multiple sclerosis, spinal cord injury– Anticonvulsant (CBD for Dravet Syndrome)

• Low quality evidence– Anxiety, sleep disorders, PTSD

• Possible role in addiction treatment– Reduce cannabis withdrawal– CBD counteracts psychoactive effect of THC– CB1 blocker rimonabant withdrawn 2008

Health Effects of Cannabis

• Comprehensive review released January, 2017 by National Academy of Science

– http://nationalacademies.org/hmd/Reports/2017/health-effects-of-cannabis-and-cannabinoids.aspx

Important Unresolved Issues

• Restricting access by teenagers

• Drugged driving

• Quality control of artisanal “medical marijuana”

• Concerns about impact of investors and commercial advertising

Current Legal Status

• Legal for medical use in 29 states and DC– Pending in 2, 2017 legislation failed in 13

• Legal for recreational use in 8 states and DC– Cannot be brought across state borders, even in

adjacent states

• Maryland– Decriminalized for recreational use

• Legalization bill failed in Maryland Legislature this year

– Legalized for medical use since 2013• Patients are now able to register

• Availability expected by “end of Summer”

• http://mmcc.maryland.gov/Pages/home.aspx

Future Cannabis Policy

• “Campaign 2016 was the first presidential race in which marijuana reform was treated as a legitimate, serious public policy issue. It was important enough so that those vying to be presidents of the United States not only were asked about their history with the drug but were also expected to develop policy.” (John Hudak, Marijuana: A Short History, p.115)

• Obama DOJ policy toward “medical marijuana” of “cooperative noninterference" is being reviewed by Trump DOJ

• July, 2017: bill to legalize was introduced in U.S. Senate by Cory Booker

OPIOIDS

Rates of Opioid Sales & OD Deaths, 1999–2013

0

1

2

3

4

5

6

7

8

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

Source: National Vital Statistics System, DEA’s Automation of Reports and Consolidated Orders System

Prescription of Opioid Analgesics

• CDC issued new guidelines for reducing the prescribing of opioid analgesics

• AMA recommends removing pain as “5th vital sign”• CMS removed patient satisfaction questions

regarding opioid prescribing from Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS)

• FDA panel recommended extending REMS– Mandatory training for opioid prescribing– Instant release formulations now Included

• Increased requirements for physicians to register for and use PDMPs

• Increased education and convenience regarding disposal of unused medication

CDC Guidelines: Prescription of Opioid Medications for Chronic Pain

1. Non-pharmacologic and non-opioid pharmacologic therapies are preferred

2. Before starting, discuss risks and benefits, reasonable goals for pain and functioning, and have plan for discontinuation

3. Begin with immediate-release instead of extended-release/long-acting (ER/LA) opioids

4. Periodically reevaluate and work to lower dose or discontinue

CDC Guidelines: Prescription of Opioid Medications for Chronic Pain

5. Use urine testing before starting and periodically thereafter

6. Use Prescription Drug Monitoring Program (PDMP)

7. Avoid using opioids for patients taking benzodiazepine medication

8. Screen for history of substance use disorder

Opioid Related Overdose Deaths United States, 1999-2013

Death Rates by Age Group from Overdoses of Heroin or Prescription Opioid Pain Relievers

SOURCE: CDC. Increases in Heroin Overdose Deaths — 28 States, 2010 to 2012

MMWR. 2014, 63:849-854

Continued Rise in Opioid Overdose Deaths

• Caused by the addition of potent synthetic opioids to heroin– Fentanyl and carfentanil (animal tranquilizer)

are being produced illicitly in China rather than diverted from legitimate medical use• Overdose of Prince was on fentanyl

• Third wave, after prescription opioids and heroin

Kratom

• Derived from leaves of Southeast Asian tree

• Active ingredient: mitragyna alkaloids

• Low dose: stimulant effect

• Higher doses: activates opioid receptors and can relieve pain

• Used for centuries for medicinal purposes

• Addictive use resembles opioids

• Under political pressure, DEA reversed its decision to place it in Schedule 1

• Cumulative: 5,030

• Admitted in 2016: 501

• Current: 287– Longer than 1 year: 39%

– Longer than 2 years: 24%

– Variation by office:• Baltimore area: 76%

• Washington area: 24%

Buprenorphine for Kolmac Patients

Expanded Use of Buprenorphine

• Over one million patients now taking it– Compare to quarter million on methadone

• Incorporation into traditional 12-Step based residential treatment program– Hazelden/Betty Ford project

• Increased patient limit to 275 for physicians:– With addiction certification– Who have had a waiver for the 100 patient limit for at

least one year– Or who practice in a qualified health setting (provide

counseling and accept insurance)

• NPs and PAs now allowed to prescribe (30 100)

Diversion of Buprenorphine

• Maryland Medicaid forced conversion of many patients off of Suboxone because of complaints of State law enforcement about diversion of that formulation in jails and prisons

– Efforts underway by addiction specialists to reconsider this decision

• Street use for relief of withdrawal rather than euphoria

• Treatment staff– Negative methadone experiences

• Patients– Concern about getting off– “Not really in recovery”

• Patient families– Negative publicity– “Exchanging one drug for another”

• Addiction treatment community• Narcotics Anonymous

– “Unable to work the steps”

• HHS Secretary, Tom Price• Lobbying by Alkermes (manufacturer of Vivitrol)

Addressing Resistances

• Prior authorization: now banned in Maryland• Stabilization doses

– Vary by individual

• Co-morbid pain management– Chronic– Elective surgical procedures

• Specialized group vs. integrating with other substance users

• Discontinuing– When: task versus time based– How: protocols, Butrans patch– Relationship to long term recovery

Ongoing Issues With Buprenorphine

• Integrating with outside community

– “Warm handoff” study at University of Maryland Hospital

– Initiating treatment in ED with coordinated next day continued treatment with collaborating treatment programs

– Shifting patient to primary care physician

• Use of one day dose in withdrawal management protocol to expedite naltrexone induction

Future Possibilities

BENZODIAZEPINES

Prescription of Benzodiazepines

• Steady increase in number of prescriptions being written

• Concern about interaction with opioids

– FDA black box warning on co-prescribing of benzodiazepines and opioid analgesics

– FDA is reviewing co-prescribing of benzodiazepines with opioids for medication assisted therapy

POLICY ISSUES

War on Drugs

• Wound down under Obama administration– Presidential commuting of sentences of nonviolent

drug offenders in federal prisons related to earlier decision to eliminate disparity between sentences for powdered and crack cocaine

– Justice Department decision to phase out use of private prisons that had grown due to war on drugs

• Possible resumption under Trump administration– AG Sessions threatens increased prosecution of

cannabis use and suggests return to “Just say no.”

Renewed Interest in Harm Reduction

• Needle exchange

• Protected sites for heroin use

• Decriminalization

– Cannabis in Canada

– Total in Portugal

Impact of Policy Changes on Addiction Treatment

• Affordable Care Act changed reimbursement formulas to incentivize cost-effective treatment– Penalizing hospitals for 30 day readmissions

• “Warm handoffs” research at University of Maryland

– CareFirst reducing or eliminating large deductibles for addiction treatment

• Maryland Hospital Services Cost Review Commission– Established global budgets and incentives for

hospitals to partner with community providers• Project to embed addiction and mental health clinicians

from Kolmac and Sheppard Pratt into GBMC primary care practices

President’s Commission on Combating Drug Addiction and the Opioid Crisis, 7/31/17

• Declare national public health emergency

• Expand addiction treatment capacity

• Mandate prescriber education on opioids

• Fund access to medication assisted treatment, including all 3 options

• Increase interstate capacity of Prescription Drug Monitoring Programs (PDMP)

• Enforce parity for behavioral health

Professional Learning Opportunities

• American Society of Addiction Medicine (ASAM) Associate Membership

– Access to publications, educational events

– Maryland/DC Society of Addiction Medicine (MDSAM)

– $260

Thank youGeorge Kolodner, M.D.

gkolodner@kolmac.com

Follow Kolmac Blog: www.kolmac.com/category/articles