“Addressing Opiate Abuse”

William B. Lawson, MD, PhD, DLFAPAAssociate Dean of Health Disparities

University of Texas at Austin

Dell Medical School

william.lawson@austin.utexas.edu

Opioids

• Medications that relieve pain

• Reduce the intensity of pain signals reaching the brain and affect those brain areas controlling emotion, which diminishes the effects of a painful stimulus

• In addition to their pain relieving properties, some of these drugs—codeine and diphenoxylate (Lomotil) for example—can be used to relieve coughs and severe diarrhea

Opiates & Opioids

Opiates = naturally present in opium

• e.g. morphine, codeine, thebaine

Opioids = manufactured• Semisynthetics are derived

from an opiate– heroin from morphine

– buprenorphine from thebaine

• Synthetics are completely man-made to work like opiates

– methadone

This class includes :

Hydrocodone (e.g., Vicodin)

Oxycodone (e.g., OxyContin, Percocet)

Morphine (e.g., Kadian, Avinza)

Codeine

Heroin

Methadone

The problem

According to the (CDC), in 2012, US providers

wrote 259 million prescriptions for painkillers,

enough for every American adult to have a

bottle of pills. The CDC also reports that 46

Americans die every day from overdosing on

prescription painkillers.

Pain Relief and Euphoria

Who Gets Addicted?

• Jamie Fox

• Rush Limbaugh

• Whitney Houston

• Robin Williams

• Prince?

Use Among Youngsters

Children’s Safety Network. Texas 2015 Fact Sheet.

https://www.childrenssafetynetwork.org/sites/childrenssafetynetwork.org/files/Texas%202015%20State%20Fact%20Sheet.pdf.

Consequences

Neurotoxicity

AIDS, Cancer

Mental illness

Health care

Productivity

Accidents

Homelessness

Crime

Violence

HIV and Hepatitis

Injection drug use and needle sharing are responsible for about 10% of HIV cases annually, and one in six people with HIV/AIDS have used an illegal drug intravenously in their lifetime

Co-infection with hepatitis C occurs in a quarter of Americans living with HIV. Among injection drug users and needle sharers, rates of co-infection are even higher (80%). Most people with hepatitis C are unaware of their infection and, for many, this can result in significant damage to the liver including the development of life-threatening conditions such as cirrhosis or hepatocellular carcinoma. Among people living with HIV, liver disease due to hepatitis C is the most common cause of non-AIDS related death.

Why Do Some People Use Drugs?

To feel

goodTo have novel:

feelings

sensations

experiences

AND

to share them

To feel

betterTo lessen:

anxiety

worries

fears

depression

hopelessness

Addiction

• A chronic, relapsing brain disease that is characterized by compulsive drug seeking and use, despite harmful consequences.† It is considered a brain disease because drugs change the brain—they change its structure and how it works. These brain changes can be long-lasting, and can lead to the harmful behaviors seen in people who abuse drugs. severe substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5, 2013).

Dependence vs. Addiction• Physical dependence occurs because of normal adaptations to chronic exposure to a

drug and is not the same as addiction. Addiction, which can include physical

dependence, is distinguished by compulsive drug seeking and use despite sometimes

devastating consequences.

• Someone who is physically dependent on a medication will experience withdrawal

symptoms when use of the drug is abruptly reduced or stopped. These symptoms can

be mild or severe (depending on the drug) and can usually be managed medically or

avoided by using a slow drug taper.

• Dependence is often accompanied by tolerance, or the need to take higher doses of a

medication to get the same effect. When tolerance occurs, it can be difficult for a

physician to evaluate whether a patient is developing a drug problem, or has a real

medical need for higher doses to control their symptoms..

Drugs Are Usurping Brain Circuits

And Motivational Priorities

Circuits Involved In Drug Abuse and Addiction

All of these must be consideredin developing strategies to effectively treat addiction

Key area: nucleus acumbens

0

50

100

150

200

0 60 120 180

Time (min)

% o

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Empty

Box Feeding

Di Chiara et al., Neuroscience, 1999.

FOOD

MountsIntromissionsEjaculations

Fiorino and Phillips, J. Neuroscience, 1997.

Natural Rewards Elevate Dopamine Levels

100

150

200

DA

Co

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Sample

Number

1 2 3 4 5 6 7 8

SEX

Female Present

Control Addicted

Cocaine

Alcohol

DA

DA

DA DADA

DA

Reward Circuits

DADA DA

DA

DA

Reward Circuits

DA

DA

DA

DA DA

DA

Drug Abuser

Non-Drug Abuser

Heroin

Meth

Dopamine D2 Receptors are Lower in Addiction

DA

Di Chiara and Imperato, PNAS, 1988

Effects of Drugs on Dopamine Release

The Chemistry

• Described as a central nervous system disorder, opiate addiction results when prolonged opiate use leads to damage of the sensory nerves and the brain which causes cells to stop producing endorphins. Medically termed endogenous opiates, endorphins are naturally occurring painkillers that, in a non-opiate abuser, stop pain by blocking the nerve perception of the pain.

Consequences

• Prolonged opiate use will lead to nerve damage that results in an inability for the body to cope with or stop pain. Damage to the nerves result a reduced or completely eliminated production of endorphins and as a result, the user is unable to mask pain. Over time, nerve cells continue to degenerate to an extent that the user requires opiates in order to feel comfortable and to prevent extreme bodily pain. This resulting damage to the nerves that stops endorphin production and causes a dependence on opiates to produce similar effects is known as opiate addiction.

Opiate Sites of Action

Drug addiction is a chronic illness with relapse

rates similar to those of hypertension, diabetes,

and asthma

McLellan et al., JAMA, 2000.

Relapse Rates Are Similar for Drug Addiction & Other Chronic Illnesses

Drug Addiction

Type I Diabetes

0

10

20

30

40

50

60

70

80

90

100

Hypertension Asthma

40 t

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0%

30 t

o 5

0%

50 t

o 7

0%

50 t

o 7

0%

Perc

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ts W

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McLellan et al., JAMA, 2000.

The Drug Abuse Treatment Outcome Study

(DATOS)

• outpatient methadone

• outpatient drug-free

• long-term residential

• short-term inpatient

CORRECTIONAL SYSTEMS

• The large-scale incarceration of drug users

has resulted in a disproportionate rate of

infection and burden of HIV/AIDS among the

prison population, and correctional facilities

have emerged as critical settings for

interventions to prevent, diagnose, and treat

HIV and other infectious diseases.

Report: Treating Drug Users to Reduce Crime

• Cuts drug abuse in half• Reduces criminal activity up to 80

percent• Reduces arrests up to 64 percent • Reduces the spread of HIV/AIDS,

hepatitis, and other infectious diseases • Treatment was greatly

enhanced by drug court and buprenorphine programs

NIH Record. NIDA Recommends Treating Drug Abusers To Save Money, Reduce Crime. https://nihrecord.nih.gov/newsletters/2006/09_08_2006/story04.htm. September 8, 2006.

Tim Bell former offender and Substance User

Dr. Volkow unveils new report

Non Medical Treatments

Cognitive Behavioral Therapy seeks to help patients recognize, avoid, and cope with the situations in which they are most likely to abuse drugs.

Contingency Management uses positive reinforcement such as providing rewards or privileges for remaining drug free, for attending and participating in counseling sessions, or for taking treatment medications as prescribed.

Motivational Enhancement Therapy uses strategies to evoke rapid and internally motivated behavior change to stop drug use and facilitate treatment entry.

Family Therapy (especially for youth) approaches a person’s drug problems in the context of family interactions and dynamics that may contribute to drug use and other risky behaviors.

Medication Assisted Therapy

Opioid Addiction

– Methadone

– Buprenorphine

– Naltrexone

MAT

The cravings and withdrawal symptoms associated with quitting opiate use are very strong and difficult to overcome. It is for this reason that medication-assisted treatments are often recommended. These therapies address the changes that drugs have caused in a user’s brain, according to the National Institute on Drug Abuse. The most common drugs used to treat opioid addiction and dependence are opioid agonists or partial opioid agonists, which interact with and activate the opiate receptors in the brain

Methadone Clinics & MMT

One of the most common ways of overcoming opiate addiction is to seek treatment in a methadone clinic or through methadone maintenance treatment. Methadone maintenance treatment involves being administered a dosage of methadone each day which will counteract the withdrawal symptoms by tricking the body into believing that it is still using heroin or other opiates.Methadone maintenance is most effective when combined with counseling and therapy.

About Buprenorphine Therapy

• In October 2002, the Food and Drug Administration (FDA) approved buprenorphine monotherapy product, Subutex®, and a buprenorphine/naloxone combination product, Suboxone®, for use in opioid addiction treatment. The combination product is designed to decrease the potential for abuse by injection. Subutex® and Suboxone® are currently the only Schedule III, IV, or V medications to have received FDA approval for this indication.

36

The Case for Buprenorphine The spread of HIV in the U.S. is fueled in part by the

use of illicit drugs.

Injection drug use is directly related to HIV transmission through the sharing of drug equipment

The use of both injected and noninjected drugs impairs decision-making and increases sexual risk-taking behavior, which increases the risk for acquiring HIV.

“Even though substance abuse treatment is crucial for staying in HIV care and adhering to a treatment regimen, it is in short supply. The introduction of buprenorphine…offers hope for improved access to treatment for addiction.”

Source: Health Resources and Services Administration, Substance Abuse and HIV/AIDS In the United

States, June 2006, retrieved 2/15/08

Methadone Vs Buprenorphine

Methadone

• No Ceiling

• Can “top off” when in treatment

• Can take months to titrate does up or down

• Diversion or mis- used

• Provided in specialized treatment centers

• Mulitple side effects at theraupeutic doses including sedation

• Depressogenic?

Buprenorphine

• Ceiling does of 32mg

• Blockade effect, limiting the effects of additional opioid use

• High Safety profile

• Low potential for abuse and diversion

• Provided

• Minimal side effects

• Putative antidepressant effect

Buprenorphine’s Properties

• Is a synthetic opioid

• Partial agonist:

– Less reinforcing than a full agonist

• But more acceptable to patients than a full

antagonist

– Easier withdrawal

– Safety – overdose ceiling effect

Friedman_march 2005

Partial Agonist Activity Levels

no drug high dose

DRUG DOSE

low dose

%

Receptor

Intrinsic

Activity

0

10

20

30

40

50

60

70

80

90

100Full Agonist (e.g. heroin)

Partial Agonist (e.g. buprenorphine)

Like full agonists, partial agonist drugs increase activity at lower doses

At higher doses, even when partial agonist binds all receptors, maximal agonist effect is never achieved

Buprenorphine Patient Outcomes:

Specific Criminal Activities“In the past 30 days were you involved in any of the

following activities…?”

16%

10% 10%

1% 1%1%2%

1%

3%

0%

5%

10%

15%

20%

Drug Dealing Prescription Fraud Other Crimes

Baseline 30 Day 6 Month

4

n=37

9Source: SAMHSA Patient Longitudinal Study, November 2005

Perc

en

t o

f P

ati

en

t S

am

ple

Buprenorphine Patient Outcomes:

Acquisition of Drugs on the Street

“In the past 30 days, how many days did you get drugs ‘on

the street’?”

1.72

13.16

0.100

5

10

15

20

25

30

Baseline 30 Day Followup 6 Month Followup

Source: SAMHSA Patient Longitudinal Study, November 2005

Me

an

Days

in

La

st

30

Buprenorphine Patient Outcomes: Percent of

Patients Acquiring Drugs on the Street

20%

4%

67%

0%

20%

40%

60%

80%

100%

Baseline 30 Day Followup 6 Month Followup

Source: SAMHSA Patient Longitudinal Study. November 2005

Pe

rce

nt

of

Pa

tie

nt

Sa

mp

le

Patient Report of Counseling Sessions:

First 30 Days of Buprenorphine Treatment

4% 4%3%

8%

12%

10%10%

6%

41%

2%

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

0 1 2 3 4 5 10 20 30 31+

Number of Counseling Sessions per Patient

4

3

Pe

rce

nt

of

Pa

tie

nt

Sa

mp

le

n=34

7

Source: Evaluation of the Buprenorphine Waiver Program, conducted by SAMHSA/CSAT from 2002-2005

How to Obtain a Waiver

Physician Waiver Qualifications• The Drug Addiction Treatment Act of 2000 (DATA 2000) enables qualifying physicians to receive a waiver from the special registration

requirements in the Controlled Substances Act for the provision of medication-assisted opioid therapy. This waiver allows qualifying physicians to practice medication-assisted opioid addiction therapy with Schedule III, IV, or V narcotic medications specifically approved by the Food and Drug Administration (FDA). On October 8, 2002 Subutex® (buprenorphine hydrochloride) and Suboxone® tablets (buprenorphine hydrochloride and naloxone hydrochloride) received FDA approval for the treatment of opioid addiction.

To receive a waiver to practice opioid addiction therapy with approved Schedule III, IV, or V narcotics a physician must notify the Center for Substance Abuse Treatment (CSAT, a component of the Substance Abuse and Mental Health Services Administration) of his or her intent to begin dispensing or prescribing this treatment. This Notification of Intent must be submitted to CSAT before the initial dispensing or prescribing of opioid therapy. The “waiver notification” section on this Site provides information on how to obtain and submit a Notification of Intent form. The Notification of Intent can be submitted on-line from this Web site, or via ground mail or fax.

The Notification of Intent must contain information on the physician’s qualifying credentials (as defined below) and additional certifications including that the physician has the capacity to refer such addiction therapy patients for appropriate counseling and other non-pharmacologic therapies, and that the physician will not have more than 30 patients on such addiction therapy at any one time for the first year. (Note: The 30-patient limit is not affected by the number of a physician’s practice locations. One year after the date on which the physician submitted the initial notification, the physician will be able to submit a second notification stating the need and intent to treat up to 100 patients.)

The Drug Enforcement Administration (DEA) assigns the physician a special identification number. DEA regulations require this ID number to be included on all buprenorphine prescriptions for opioid addiction therapy, along with the physician’s regular DEA registration number.

WAIVER

DATA 2000, part of the Children’s Health Act of 2000, permits physicians who meet certain qualifications to treat opioid dependency with narcotic medications approved by the Food and Drug Administration (FDA)—including buprenorphine—in treatment settings other than OTPs.

The Act permits qualified physicians to obtain a waiver from the separate registration requirements of the Narcotic Addict Treatment Act – 1974 (PDF | 437 KB) to treat opioid dependency with Schedule III, IV, and V medications or combinations of such medications that have been approved by FDA for that indication. Learn more about buprenorphine to treat substance use disorders.

WAIVER

Physicians can complete the online Waiver

Notification Form SMA-167 or download,

complete, and fax Waiver notification Form

SMA-167 (PDF | 62 KB) to 240-238-9858.

Buprenorphine, Health Disparities and

Diversion

• Lack of access to physician services may be contributing to the diversion and abuse of buprenorphine

– Financial barriers keep some patients from being able to get their own prescription from a physician

– Limited number of prescribers may also be a factor.

• Patients selling their buprenorphine to others dependent on opioids may not hesitate to sell their drugs to non-opioid dependent users.

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Going Forward

Last October, AAAP along with AMA, AOA, ADA and many other medical, osteopathic, dental, and other health professional organizations committed collectively to reduce opioid overdose deaths and more effectively treat opioid use disorders. Key measures of our success over the next two years include:

Having more than 540,000 health care providers complete opioid prescriber training;

Doubling the number of physicians certified to prescribe buprenorphine for opioid use disorder treatment;

Doubling the number of providers who prescribe naloxone--a drug that can reverse an opioid overdose;

Doubling the number of health care providers registered with their State Prescription Drug Monitoring Programs

Treating a Biobehavioral

Disorder Must Go Beyond Just

Fixing the Chemistry

• Pharmacological (medications)

• Behavioral Therapies

• Medical and Social Services

Drug Rehabilatation

Some people do not want to go forward with only medication-assisted therapy and therefore do not wish to take part in a methadone maintenance program. For those who decide not to quit cold turkey but also not to take part in a medication replacement program, drug rehab is an option. Drug rehab involves a combination of medical intervention, monitoring, peer support and counseling to effectively help patients overcome opiate addiction. Many drug rehab programs do utilize methadone maintenance of Suboxone, but most provide alternatives that are also effective at helping patients get past the strongholds of opiate addiction and move on with their lives.

About SBIRThttp://sbirt.samhsa.gov/index.htm

An Early Intervention Approach• The SBIRT Initiative represents a paradigm shift in the provision of treatment for substance use and abuse. The services are different

from, but designed to work in concert with, specialized or traditional treatment.

• New Target Population

• The primary focus of specialized treatment has been persons with more severe substance use or those who have met the criteria for a Substance Use Disorder. The SBIRT Initiative targets those with nondependent substance use and provides effective strategies forintervention prior to the need for more extensive or specialized treatment.

• System for Assessment, Intervention, and Treatment

• The Initiative involves implementation of a system within community and/or medical settings—including physician offices, hospitals, educational institutions, and mental health centers—that screens for and identifies individuals with or at-risk for substance use-related problems. Screening determines the severity of substance use and identifies the appropriate level of intervention. The system provides for brief intervention or brief treatment within the community setting or motivates and refers those identified as needing more extensive services than provided in the community setting to a specialist setting for assessment, diagnosis, and appropriate treatment.

• Approach is Successful

• As of August 2007, SBIRT grantees funded by SAMHSA have screened over 536,000 individuals. Through grantees efforts, researchers are learning how to integrate SBIRT into primary care. Preliminary data suggest the approach is successful in modifying the consumption/use patterns of those who consume five or more alcoholic beverages in one sitting and those who use illegal substances. These grantees have implemented SBIRT in trauma centers/emergency rooms, community clinics, federally qualified health centers, and school clinics.

Treat the Whole Person!

• No single Treatment is appropriate

for all individual

• Treatment must attend to multiple

needs of the individual

• Remaining in treatment for adequate

time is vital for success

• Treatment should be readily

available no matter race, gender,

orientation, or socio-economic status

We Are Getting There Slowly but Surely!