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A More Recent Valued Addition

•Peer support staff•Used in conjunction with, or following active

treatment•Peer support counselors have become more accepted,

credentialed and reimbursable by payers

This improves outcome, but still not enough

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So We Add Pharmacotherapy for

Substance Use Disorder Relapse Prevention

Why Is MAT Necessary?

• The need to understand addiction as a chronic, relapsing brain disease• Need to heal the brain after prolonged drug use because of

injury to brain circuits involved in:• reward• impulsivity• decision making

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Evidenced-Based Treatment for Relapse Prevention

ASAM Dimension 5

The Use of Anti-Addiction Medications

Why Psychosocial Treatments Alone Are Limited in Effectiveness

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NIDA’s Comprehensive Care-Related Principles of Effective Drug Addiction Treatment

NIDA Comprehensive Care-Related Principles of Effective Drug Addiction Treatment

• Effective treatment attends to multiple needs of the individual, not just his or her drug use• Counseling (individual and/or group) and other behavioral therapies

are critical components of effective treatment for addiction• Medications are an important element of treatment for many

patients, especially when combined with counseling and other behavioral therapies.

Why Pharmacotherapy?

Death Rates/Year – all causes:

• Alcohol: 80,000• Accidents, overdose, resultant medical problems• Opioids: 30,000• Overdose, resultant medical problems• Cannabis: <50• Probably more when considering impaired

driving • NO current medications

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More Bad News• Nearly 23 million Americans over age 12 are now addicted to an illicit

or prescription drug and/or alcohol• 4.5 million individuals in the U.S. were current (past month) non-

medical users of prescription opioids (2013)• 289,000 were current (past month) users of heroin• The leading cause of death in people using opioids for nonmedical

purposes are overdose and trauma• This is more than those with heart disease or cancer• Does not include death due to tobacco/electronic nicotine delivery

systems (vaping)• One in 4 deaths attributed to SUDs

More of the Reality of Opioid Dependence

• 2.0 million people in the U.S. have prescription opioid dependence (2015) • In 2016, Drug overdose deaths reached another record — topped

total US casualties from the entire wars in Vietnam and Iraq.• Only 18% receive treatment• 591,000 people had a heroin disorder (2015)• Sales of legal opioids have increased 400% in last 10 yrs.§ Overall opioid prescriptions went from 112 million in 1992 to 282

in 2012 and per-capita consumption quintupled§ Most O.D. deaths among adolescents and 20 years olds§ With increasing restrictions on prescription opioid, there has been

a switch to heroin

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Overdose Deaths

• 68,557 opioid overdose deaths in 2018. An estimated 47,590

involved opioids, and 31,897 involved synthetic opioids, such as fentanyl

and tramadol. (July 17, 2019), more than any year on record.

• Nearly half of all opioid overdose deaths involve a prescription opioid.

• Estimates for next 10 years is 500,000 O.D.s

• In 2015, among the the five states with the highest rates of death due to

drug overdose were two of the New England states, New Hampshire and

Rhode Island

• Opioids continue to be the most significant contributor to overdose

deaths exceeding drug-related deaths from all other intoxicants

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The NIH has Awarded a $3.8 Million Grant to Study Whether Medical Marijuana Reduces Opioid Use among Adults with

Chronic Pain, including People with HIV.

For opioid dependence, consideration should

always be given to anti-addiction medications

along with psychosocial treatment

• Methadone• Buprenorphine (“Subutex”)• “Suboxone” (buprenorphine + naloxone)• “Sublocade” (Once/mo. buprenorphine + naloxone, I.V. injection)• Naltrexone• Sustained release injectable naltrexone (�Vivitrol�)

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Agonist Treatment Has Been Shown to Reduce Mortality

by 50%!

Evidence-Based Treatments for Opioid Addiction

• Three classes of medications have been approved for the treatment of opioid addiction:• (1) agonists, e.g. methadone, which activates opioid

receptors; • (2) partial agonists, e.g. buprenorphine, which also activates

opioid receptors but produces a diminished response; • (3) antagonists, e.g. naltrexone, which blocks the opioid

receptor and interferes with the rewarding effects of opioids• These medications represent the first-line treatments for

opioid addiction.

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When Do You Medicate for Addictive Disorders?

When the risk of not medicating exceeds the risk of medicating!

Any side effects of anti-addiction medications are clearly less of a concern than continuing to use the opioids

AGONIST DRUGS

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Differing Treatment Program Approaches to the Use of Anti-Addiction Medications

1. Appropriate selection of patients and appropriate use (smallest group)

2. Grudging use resulting in under-utilization and sometimes used only after a relapse

3. No use because opposed on philosophical grounds

To be opposed to the use of medication assisted treatment

for the treatment of addictive disorders on philosophical grounds,

is like being opposed to insulin for diabetics

on philosophical grounds!!!

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Methadone

Methadone

• Used for detoxification or maintenance• Any physician with DEA number can prescribe

methadone for pain management • Only a federally licensed methadone clinic can use

methadone for maintenance

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Methadone Clinics and Stigma• In addition to the stigma associated with taking methadone, other

issues which lead to stigma are:• Clinics often look like and are organized like probation offices, e.g.,

line up, pee in a cup• The location of methadone clinics, depressed areas• In contrast to Suboxone, those in methadone clinics tend to be

minorities and of lower socioeconomic class• Payment is often by Medicaid because patients do not have

private insurance to pay for Suboxone although that is changing• Because of the need for daily dosing (at least until stable enough

for take home dosing), these patients are less likely to be employed

Methadone• Can only be dispensed for maintenance

from a licensed/accredited methadone clinic• Very strict federal controls• Drug of choice for pregnant opioid

addicts being replaced with Subutex• While methadone is a primary cause

of overdoses, the drug generally does does not come from methadone clinics but physicians using methadone for pain management

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Federal Regulations for Admission for Methadone Maintenance• At least 18 years of age;

• Document, at least, one year history of addiction. A positive opiate drug test is not required if an individual meets DSM-IV requirements for opiate dependence or if an individual is clearly at risk of relapse while receiving services in an abstinence based program;

• Current physiological dependence on opiates of a one year history of addiction;

• Exceptions to minimum admission criteria of current physiological dependence on opiates or a one year history of addiction can be made under the following circumstances: • Individuals who have been in penal or chronic care for six months or

longer; • Patients 16-18 years of age require a two year history of addiction;• Pregnant patients; • Previously treated patients; Individuals who complete MSW (Medically

Supervised Withdrawal) within 30 days of treatment.

Priority for admission for the following

• Pregnant patients; • Individuals at risk for relapse; • Previously treated patients; • Patients just released from jail and/or

hospital.

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Reducing Stigma for Methadone Programs• Staff members should treat patients with respect and pay attention to the

terms they use• The term “substitution treatment” should be avoided because it

incorrectly implies that long-acting opioid medications act like heroin and other short-acting opioids• Terms such as “dirty” and “clean” in reference to drug-test specimens

should be replaced by more clinically useful terms such as “positive” and “negative,” respectively • Methadone programs should become better neighbors. Idle, perhaps

intoxicated, patients who remain near an OTP can become, by default, the program's public representatives and easy targets for complaints from the community• Frequently, patient loitering is a result of insufficient program

management. Patient conduct in and around OTPs should be considered both a treatment and a community relations concern.

This from a Social Network for Physicians

•Posted November 28, 2017 - 06:31AM EST• “Heroin addicts want to die then I say let them die. I

know that's a heartless thing to say but these addicts rarely if ever stop using. I say “no” to Narcan”.

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Switch from Methadone to Buprenorphine• Patients can possibly switch from methadone to

buprenorphine treatment, but because the two medications are so different, patients may not always be satisfied with the results• Studies indicate that buprenorphine is equally as effective as

moderate doses of methadone• However, because buprenorphine is unlikely to be as

effective as more optimal-dose methadone, it may not be the treatment of choice for patients with high levels of physical dependence

FDA Recommendation

• U.S. Food and Drug Administration is advising that the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS). • The combined use of these drugs increases the risk of serious side

effects• However, the harm caused by untreated opioid addiction can

outweigh these risks. • Careful medication management by health care professionals can

reduce these risks.

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Funding – Methadone Programs

• Most expansion in the methadone treatment system in the past 10 years has occurred in the proprietary sector• Historically, most OTPs were funded publicly, whereas proprietary

programs were in the minority• In the 1980s, public funding for methadone treatment began to be

reduced, along with State, Federal, and local budgets, and increasingly was replaced by private fee-for-service treatment programs in which patients (and sometimes Medicaid) bore more of the costs

Who Are Methadone Patients?

•May have unsuccessfully tried abstinence treatment, many multiple times• Significant co-occurring disorders• Significant histories of antisocial/criminal behavior• Usually poor• At ”the end of the line,” last stop

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Chronic Pain and the Opioid Dependent Patient

• In studies, the majority of methadone patients had chronic pain defined as > 6 months and of moderate to severe intensity• MMTP patients have been shown to have lower pain thresholds

compared with matched controls (persons with no history of substance abuse or dependence)• This may be a factor in the initiation or continuation of the opioid use• Methadone can be used to treat chronic pain• However, its duration of action is only 4 – 8 hours, considerably less

than the 24 hour dosing in methadone maintenance• Treatment options may include giving the methadone in divided

doses and using non-opioid drugs and/or non-pharmacological interventions

Pain Scales

• The Joint Commission requires that all patients be assessed for pain and if the pain level is over 5, it must be addressed

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Co-Occurring MH Disorders in anOlder Methadone Population

• One study revealed that over half (57.1%) of respondents had at least one mental health disorder in the past year• In the year before the interview, the most prevalent mental health

disorder experienced by older adult methadone patients was major depressive episode (32.9%)• The most prevalent anxiety disorders were posttraumatic stress

disorder (27.8%) and generalized anxiety disorder (29.7%)• Additionally, women experienced significantly higher levels of

depression than males (43.8% versus 27.2%), and nearly twice the prevalence rate of agoraphobia and panic disorders.

Heroin Maintenance• More than a half dozen countries in Europe and Canada have

implemented heroin-assisted treatment generally in conjunction with methadone• Great Britain has has it since the 1920s• Heroin assisted treatment is fully a part of the national health system

in Switzerland, Germany, the Netherlands and Denmark• Also, the notion that patients in heroin assisted treatment are enabled to

maintain "destructive behavior" contradicts the findings that patients significantly recover in terms of both their social and health situation. A clinical follow-up report on the German "Heroin studie" found that 40% of all patients and 68% of those able to work had found employment after four years of treatment. Some even started a family, after years of homelessness and delinquency • Results compared to methadone alone:• Slight advantage of treatment retention

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Heroin Maintenance• The available evidence suggests an added value of heroin prescribed

alongside flexible doses of methadone for long-term, treatment refractory, opioid users, to reach a decrease in the use of illicit substances, involvement in criminal activity and incarceration, a possible reduction in mortality; and an increase in retention in treatment. • Due to the higher rate of serious adverse events, heroin prescription

should remain a treatment for people who are currently or have in the past failed maintenance treatment, and it should be provided in clinical settings where proper follow-up is ensured• BUT…The heroin users on these programs were requested to attend the

clinic to receive and inject prescribed heroin from two to three times a day.

OMT ---> OTS• In the ASAM PPC-2R, Opioid Maintenance Treatment (OMT)

referred specifically to methadone maintenance and the only FDA approved medication was methadone• Since that time, there have been other agonist drugs

developed, e.g., buprenorphine, (in its two form Subutex and Suboxone) and development and increasing use of antagonist drugs, e.g., oral naltrexone, extended release, injectable naltrexone (Vivitrol)• Now the ASAM section is referred to a Opioid Treatment

Services (OTS) which includes both agonist and antagonist drugs

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Buprenorphine

Buprenorphine• Used for detoxification or maintenance

• Lower abuse potential than methadone

• Lower level of physical dependence (less withdrawal discomfort)

• Ceiling effect doses

• Less likely to overdose

• Qualifying physicians (8 hour course) can prescribe/administer in office practice

• New current limit is 275 patients

• Qualifying NPs and PAs require 24 hrs. course

• Lower doses of buprenorphine (2-6 mg.) has lower retention rate than low does of methadone (40 mg. or less)

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Treatment Challenges• Unfortunately, medications approved for the treatment of

opioid abuse are underutilized and often not delivered in an evidence-based manner• Fewer than half of private-sector treatment programs offer

these medications; and of patients in those programs who might benefit, only a third actually receive it• Further, many people suffering with opioid addiction do not

seek treatment. Identifying the need for and engaging them in treatment is an essential element of addressing the opioid crisis. Recent research suggests that initiating patients on buprenorphine following an opioid overdose can increase treatment retention and improve outcomes.

Waivered Physicians in the US

• In order to prescribe buprenorphine for maintenance, a physician must go through an 8 hour course (e.g., become waivered)• In the US 46,500 physicians have been waivered•Of that group 50% do not prescribe it!•Pas and NPs can prescribe after 24 hour course

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Treatment Challenges•While users seeking treatment are on a wait list they generally

continue to engage in opioid use and this may contribute to failure to enter treatment when a slot becomes available, overdose or further criminal behavior• Research has shown that providing interim treatment with

medications while patients are awaiting admission to a treatment program increases the likelihood that they will engage in treatment• In one study, over 64 percent of study participants receiving

interim methadone entered comprehensive care within six months, compared with only 27 percent in the control group, and the group receiving methadone had lower rates of heroin use and criminal behavior.

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Long-Term Follow-Up of Suboxone

• Addiction to opioid pain relievers• 50% reported abstinence 18 months after starting therapy• After 3.5 years, 61% reported abstinence• Fewer than 10% met current criteria for dependence• At follow-up, those still engaged on opioid agonist therapy were

much more likely to report abstinence than those who stopped

NIDA Clinical Trials Network, Prescription Opioid Addiction Treatment Study, , Potter, J.S., Dreifuss, J.A., Marino, E.E., 2015

Suboxone and Subutex

Adding naloxone to buprenorphine was thought to decrease the potential for diversion and misuse of buprenorphine because, if injected, the naloxone should precipitate withdrawal in a patients already physically dependent on other opioids.

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Suboxone Film

Role of Clonidine (Catapres)• Receiving clonidine in addition to buprenorphine had

increased abstinence from opioids and were able to decouple their stress from drug craving• Additionally, participants in the buprenorphine-plus-

clonidine group, not only experienced longer periods of abstinence, but were also better in managing, or coping with their “unstructured” time. In other words, clonidine helped persons deal with their boredom and inability to create or engage in healthy activities, which is a strong predictor of relapse.

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Agonist Diversion

•Methadone: Most methadone found on the street does not come from methadone clinics but rather from physicians writing pain management prescriptions• Buprenorphine: Most buprenorphine found on the street is

used by opioid addicts to manage withdrawal symptoms when their primary drug is unavailable

Probuphine•A 6 month implantable buprenorphine•An attempt to deal with the compliance problems and

diversion• Should be used patients who have achieved and

sustained prolonged clinical stability on low-to-moderate doses of a transmucosal buprenorphine-containing product (i.e., doses of no more than 8 mg per day of Subutex or Suboxone)•Requires a minor surgical procedure

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Sublocade• A once a month injectable buprenorphine• Helps with the adherence issues• Because of the serious risk of potential harm or death from

self-injecting SUBLOCADE into a vein (intravenously), it is only available through a restricted program called the SUBLOCADE REMS Program.• SUBLOCADE is not available in retail pharmacies.• Your SUBLOCADE injection will only be given to you by a

certified healthcare provider.

Buprenorphine & Levels of Care

•Most buprenorphine is used in outpatient levels of care. The value to this is that the patient lives in the real world• Can be used in any level of care• It is advisable that for patients in inpatient or residential

levels of care, or in criminal justice settings, induction should occur PRIOR to discharge with a follow-up plan

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Agonist Treatment Further Broken Down

• Office-Based Opioid Treatment (OBOT)• An office-based practice in which the physician can prescribe

buprenorphine or any of the antagonist drugs• In order for the physician to prescribe buprenorphine he or

she must go though an 8-hour training• There was a 30-patient limit but the DEA could authorize 100

patients after the first year• Now 275 patient limit• Now PAs and NPs can prescribe (24 hours training required)

Opioid Antagonist Drugs

•Oral Naltrexone•Vivitrol (injectable, long-acting naltrexone)

FDA approved for both alcohol & opioids

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Oral Naltrexone• Naltrexone is used to treat alcohol or opioid drug dependence. It

reduces the pleasurable effects of alcohol and as an opioid antagonist, it helps block the effects of narcotic (opioid) drugs, such as heroin and other opioids. • It may help reduce cravings for opioids & alcohol.• Diminished desire for substance use is an optimum outcome of

naltrexone treatment and response of use.• Most studies show that naltrexone significantly reduces the chance

for relapse after the person has stopped using alcohol or opioids• It also appears particularly effective for people with a family history

of alcoholism• The downside is the need for daily dosing

Kiefer F, et al. (2003). Comparing and combining naltrexone and acamprosate in relapse prevention of alcoholism: A double-blind, placebo-controlled study. Archives of General Psychiatry 60(1): 92-99.

Vivitrol• Developed with a grant from NIAAA because if

compliance issues• Originally approved by FDA only for alcohol

dependence and later for opioid dependence• Once a month injectable naltrexone• Blocks the effects of alcohol and opioids• Reduces craving•Minimizes adherence problems

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VIVITROLVIVITROL is:• A once-a-month, injectable, extended-release formulation of naltrexone•Avoids the compliance problems of daily dosing• Compatible with counseling and AA & NA• Is an opioid blocker (i.e., antagonist)• Administered by a healthcare professional•Compatible with all psychiatric medications

VIVITROL is NOT:• Euphorigenic (i.e. pleasure producing)• Addictive (no withdrawal if stopped)• Aversive (e.g. disulfiram – “Antabuse”®)•VIVITROL is NOT an agonist (e.g., methadone) or partial agonist (e.g., buprenorphine)

Urschel HC. A better way to recover: innovative support and science-based treatment , a presentation of EnterHealth. 2007.

VIVITROL

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Common Medical Contraindications

•on opioids for pain management (opioid agonists) • end stage liver disease• allergic to any of the ingredients.

Making Treatment Available to Criminal Justice Populations

• Criminal justice populations are in critical need of opioid addiction treatment, yet most do not have access to MAT • Resistance to MAT by many in the criminal justice system may be

rooted in the traditional view that medical maintenance treatment is substitution of one drug for another• Fear of diversion is a major concern• However, the Rikers Island jail facility in New York City has been

providing inmates access to methadone treatment since 1987 • Vivitrol puts fears of diversion to bed

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Referrals for MAT from the Criminal Justice System

• A new study by researchers at the Johns Hopkins Bloomberg School of Public Health found that fewer than 5 percent of people referred for opioid treatment from the criminal justice system were directed to medication-assisted programs. • This represents a significant gap as about 25% of all the

treatment referrals come from the criminal justice system.

How Vivitrol Works

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Cost for Vivitrol

• $900 - $1,100 each injection•Most commercial insurance companies and Medicaid

programs now increasingly paying for it• Alkermes, the maker of Vivitrol, will pay up to $500/month in

co-pay assistance for those who have commercial insurance, with no time limit

There Is No Magic Bullet!

All of the oral and injectable anti-craving and opioid substitution medications work best in conjunction with psychosocial treatment and/or recovery support services.

Srisurapanont M, Jarusuraisin N (2005). Opioid antagonists for alcohol dependence. Cochrane Database of Systematic Reviews .

Agonists & Antagonists Are SUPPLEMENTS, Not REPLACEMENTS!

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Comparing Suboxone to Vivitrol

• In this study population it was more difficult to initiate patients to Vivitrol than Suboxone, and this negatively affected overall relapse.• However, once initiated, both medications were equally safe

and effective• Future work should focus on facilitating induction to Vivitrol

and on improving treatment retention for both medications.

Obstacles to Resolving the Opioid Crisis

• Prior authorization for anti-addiction drugs (a return to the “fail first” policies), pharmacies refusing to fill prescriptions and law enforcement acting as gatekeepers deciding who gets access to clinical treatment.• Costs for anti-addiction drugs• Insurance not paying for non-opioid alternatives for pain treatment• Medicaid’s 16-bed limit on inpatient treatment• Too many pharmacies fail to carry Suboxone• Women suffering from addiction are serving longer jail terms than their

male counterparts• Women who must wait longer periods for an open spot at a residential

drug treatment center as a term of their probation.

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The Best Chance

The best chance for recovery for people with alcohol and opioid disorders is the combination of:• Psychosocial treatment• Recovery Support Services (RSS)• Pharmacotherapy (Medication Assisted Treatment or MAT)

Recovery

PsychosocialTreatment

RSSIncluding Case

ManagementPharmacotherapy

(MAT)

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Recovery Support Services (RSS)Rather than treatment interventions, they are case management to

provide assistance with:• Housing (for the homeless)• Transportation • Childcare• Vocational Training (for the unemployed)• Employment (for the unemployed/ex-felons)• Education (for those without a H.S diploma or GED)• Financial Counseling/Aid• Legal Aid• Parenting Training• Literacy training

Demographic Predictors of Poor Treatment Outcome

(both MH & SA)

1. Under 25 years of age2. Never married or having lived as married3. Unemployed4. No high school diploma or GED

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Implications of Language• Pharmacotherapy is often called �Medication Assisted

Treatment� or MAT•When someone with the chronic disease of diabetes uses

insulin, we don�t call it Medication Assisted Treatment•When someone with the chronic disease of hypertension uses

an antihypertensive medication, we don�t call it Medication Assisted Treatment• IT’S JUST TREATMENT!• For some, MAT equals Methadone or Buprenorphine

Maintenance (agonists) and precipitates objection the belief that if you on an agonist, �you are still addicted�• This is incorrect . . . You remain physiologically dependent!

Physical Dependence vs. Addiction• Physical dependence to opioids means that the body relies on a external

source of opioids to prevent withdrawal. Physical dependence is predictable, easily managed with medication, and is ultimately resolved with a slow taper off of the opioid.• Addiction can occur without physical dependence; consider cocaine or

methamphetamine both have little outwardly apparent withdrawal syndrome but addiction to either can devastate lives. Non-substance addictions such as gambling, sex or internet also have no physical dependence. What is common to all these addictions is the unnatural cravings that prompt the compulsive behaviors.• Physical dependence can occur without addiction; this is the common

experience of most chronic pain patients who are able to take their opioid medication as prescribed for pain but don't develop the uncontrollable compulsion and loss of control. A desire to avoid withdrawal is not addiction.

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Addiction•Compulsion +•Loss of Control +•Continued Use Despite Adverse Consequences +•Craving

Pharmacotherapy should be considered

a treatment tool as others

like group therapy or CBT

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The Problem of ADHERENCE!• Of all of the FDA approved drugs for alcohol and opioid

dependence*, all except Vivitrol are oral medications requiring the patient to take 1 to 2 pills, 1 to 3X/day.• In addition to the usual causes of medication

noncompliance, for the alcohol or opioid dependent person, the daily ambivalence about giving up the alcohol or opioid is another reason not to take the medications.

• *Implantable buprenorphine

Stephenson et al. Effects of Medication Treatment on Cue-Induced ...American Academy of Addiction Psychiatry. 2006

Pharmacy claims for NTX-PO in a plan with 1.5 million insureds for 3 years (2000-2002)

Half of patients never refilled – despite Insurance coverage

Pharmacy Claims for Oral Naltrexone

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Some Research Results

General Results in Opioid Addiction Treatment• Reduction in the use of illicit drugs• increasing employment• Reduction in criminal activity • Reduction in needle sharing • Reduction in HIV infection rates and transmission • Cost-effectiveness • Reduction in commercial sex work • Reduction in the number of reports of multiple sex partners • Improvements in social health and productivity • Improvements in health conditions • Retention in addiction treatment • Reduction in suicide • Reduction in lethal overdose

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Opiate Craving and Satisfaction with Buprenorphine Treatment

Number of Emergency Room Visits and Hospitalizations 1 Year Prior to Starting Suboxone Treatment Compared to 1 Year After.

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Results 2006-2008Reduced Average Number of Admissions

Florida Advancing Recovery/RWJ Foundation– Demonstration ProjectN=29 patients; non-randomized; no comparison group

Results 2006-2008Motivation To Quit by Injection

Florida Advancing Recovery/RWJ Foundation– Demonstration ProjectN=29 patients; non-randomized; no comparison group

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Impact on Participation in Counseling and Mutual Support Groups1,2

1. Garbutt JC, et al. JAMA. 2005;293(13):1617-1625. 2. Gromov et al. AMERSA, 2008.

Northeast Recovery Division (CRC)Vivitrol Client Outcomes

Includes clients admitted and discharged between 1/1/11 through 9/30/11 at White Deer Run -Allenwood, Cove Forge, Bowling Green at Brandywine, Wilmington Treatment Centerand Life Center of Galax

Opiate Clients

Enrolled

Opiate Clients Denied

All Other Opiate Clients

Variance(Denied)

Variance(All Other)

No. of Clients: 358 460 8,053 - -Average Length of Stay: 23.11 17.96 15.94 29% 45%% Treatment Complete: 87.3% 69.8% 66.5% 25% 31%% AMA: 10.7% 24.6% 26.6% 57% 60%Readmission Rate: 8.0% 13.4% 15.8% 40% 49%

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Of All of The FDA Approved Medications For The Treatment of Opioid Dependence,

Naltrexone/Vivitrol Is the Only One That Does Not Produce or Continue Physiological

Dependence.However, it does require initial abstinence

from opioids of 7-10/14 days before initiation

CHOOSING ANTI-ADDICTION INTERVENTION

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Desired Outcomes Determine Choice

Abstinence• Total cessation of use• When this is the measure of outcome, it may or

may not include improved functioning• Alone, less likely to be successful for opioid

dependence

MAT• Decreased use of illicit opioids• Decreased/elimination of criminal behavior• Increased employment• Enhanced social and family functioning

Barriers – Methadone vs. Buprenorphine

•Methadone treatment.•Methadone must be administered through federally approved

opioid treatment programs that inhibit access to care, especially in rural areas• The requirement for onsite dosing competes with work and

family obligations• The goals of treatment programs and patients often differ on

issues such as abstinence• Patient resistance to attending a methadone program because

of stigma

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Barriers – Methadone vs. Buprenorphine

• Buprenorphine treatment.• Buprenorphine can be prescribed in a variety of settings, and

patients can take their doses at home• The Drug Addiction Treatment Act of 2000 (DATA 2000) originally

limited the number of potential patients and the type of prescribers who were required to take an 8 hour course• Now 275/prescribers + PAs & NPs can prescribe with required

training (24 hours)

Evidence-Based Treatments for Opioid Addiction

• These medications should be administered in the context of behavioral counseling and psychosocial supports to improve outcomes and reduce relapse. • Two comprehensive Cochrane reviews, one analyzing data from 11

randomized clinical trials that compared the effectiveness of methadone to placebo, and another analyzing data from 31 trials comparing buprenorphine or methadone treatment to placebo, found that , the results of this study give further evidence that agonist treatment is a safe and effective treatment for drug dependence. Methadone and Buprenorphine are equally effective.

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Evidence-Based Treatment• Patients on methadone were over four times more likely to stay in

treatment and had 33 percent fewer opioid-positive drug tests compared to patients treated with placebo;• Methadone treatment significantly improves treatment outcomes

alone and when added to counseling; long-term (beyond six months) outcomes are better for patients receiving methadone, regardless of counseling received;• Buprenorphine treatment significantly decreased the number of

opioid-positive drug tests; multiple studies found a 75-80 percent reduction in the number of patients testing positive for opioid use;• Methadone and buprenorphine are equally effective at reducing

symptoms of opioid addiction; no differences were found in opioid-positive drug tests or self-reported heroin use when treating with these medications.

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Abstinence Rate Exceeds 60 Percent in Long-Term Follow-Up of Medication-Assisted Therapy for Dependence on Opioid Pain Relievers

Opioid Use, Opioid-related Overdose Deaths, Criminal Activity, and Infectious Disease Transmission

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My Solution to the Drug Problem

•Make all drugs legal•Require users to obtain their drugs from Comcast customer service!

NIATx.com

•Buprenorphine Organization Readiness Tool (toolkit)

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All Cause Mortality Rates

Criteria for Use of Pharmacotherapy (Who?)

Alcohol and/or opioid dependence (required); and• High addiction severity; or• High levels of craving; or • History of relapse after treatment; or• History of AMA discharge or drop-outs from

treatment; or• Potential for serious consequences or imminent

danger if used again; and• Willingness to use pharmacotherapy; and• Absence of medical contraindications (required)

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Pharmacotherapy & WHEN?

• There is the perception among patients, families, and clinicians alike that medications should be used as a last resort. • That we should wait until things get worse is a discarded approach

(“You can’t help an alcoholic until the person asks for help”)• We would never consider that approach for diabetes or cancer• It is imperative that we prevent and identify risky use and use disorders,

then intervene early and offer timely, evidence-based treatment

Pharmacotherapy & HOW LONG?• A frequently asked question is “How long does the the person have

to be on “it” (the agonist drug)• When explored, it is often found to be a thinly veiled opposition to

ANY use of the drug • People should “be on it” as long as it is working and they feel the

need to continue (“If it ain’t broke, don’t fix it”)• Any negative effects from anti-addiction medications are clearly less

than those which the medications treat• The National Institute on Drug Abuse (NIDA) recommends a

minimum of one year and possibly many years in methadone maintenance treatment for best outcomes.

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Stigma

• Several factors have made the destructive force of stigma particularly intractable including:• The isolation of MAT from mainstream medicine• Negative media reports about treatment - Positive stories

about MAT in the media are sometimes overshadowed by highly charged negative accounts, for example, stories about patients loitering outside OTPs or diversion of take-home doses. • Public impressions made by poorly run programs• Stigma is less with buprenorphine than methadone

Decriminalization As an Option?

Here's what the data says about Portugal's decriminalization:

• Drug-related HIV infections have plummeted by over 90% since 2001, Drug-related deaths in Portugal are the second lowest in the European Union

• Just three in a million people die of overdoses there, compared with the EU average of 17.3 per million

• The number of adults who have done drugs in the past year has decreased steadily since 2001. Compared to the rest of the EU, young people in Portugal now use the least amount of "legal high" drugs like synthetic marijuana, which are especially dangerous

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Decriminalization As an Option?

• The number of people in drug-treatment increased 60% from 1998 to 2011

• Portugal's decriminalization came about because the country was in crisis. In 1974, Portugal's dictatorship fell after a coup that became known as the Carnation Revolution. The country soon became flooded with drugs. By 1999, a full 1% of the population was actively addicted to heroin, and the country had the highest rate of drug-related AIDS deaths in the EU.

• The percentage of drug-related offenders in Portuguese prisons fell from 44% in 1999 to 21% in 20i2

If the Science Is There, Why Is It Not

Used More Commonly?�

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Erroneous Beliefs

•Erroneous beliefs that:üMAT is meant to replace psychosocial treatmentsüMAT is incompatible with AA/NAüVivitrol is psychoactive or addictiveüIf on an agonist, the individual is still addicted

Innovations don�t sell themselves . . .

• In 1601…Capt. James Lancaster evaluates the effectiveness

of lemon juice to prevent scurvy. Results

excellent.

• In 1747…Dr. James Lind carries out a second study. Results

excellent.

• In 1796 …British Navy finally adopts use of lemon juice to

prevent scurvy.346

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H. Westley Clark, M.D., J.D., M.P.H., CAS, FASAM

Director, Center for Substance Abuse Treatment (CSAT)

At the opening plenary session of the 2011 Cape Cod Symposium on Addictive Disorders (1,100 attendees), Dr. Clark said the following:�Failing to offer and use Medication Assisted

Treatment, particularly Vivitrol, is tantamount to malpractice!�

The Veteran�s Administration

• The VA has determined that the use of pharmacotherapy in the treatment of addictions:

IS THE STANDARD OF CARE!

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United Nations March, 2013

�A particular form of ill-treatment and possibly torture of drug users is the denial of opiate substitution treatment,� the report says, adding this is considered a human rights violation when it occurs in jails and prisons

There Is No Magic Bullet!

All of the agonist medications and Vivitrol work best in conjunction with psychosocial treatment and/or recovery support services.

Srisurapanont M, Jarusuraisin N (2005). Opioid antagonists for alcohol dependence. Cochrane Database of Systematic Reviews .

These Medications Are SUPPLEMENTS, Not REPLACEMENTS!

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IF I really believe that Addiction isa chronic, relapsing brain disease,

THEN I will treat it as a chronic disease

which means consideration of the use of medications as would occur with other

chronic diseases such as hypertension and diabetes.

CounselorObjections

to the Use ofAgonists

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Still Addicted???• Some people object to the use of methadone or buprenorphine

for opioid dependent patients because if they use them, “they are still addicted”• THIS IS FLAT OUT WRONG!• Addiction includes:• Loss of control• Compulsion• Continued use in spite of adverse consequences• Craving

• If they are not abusing methadone or other psychoactive drugs, they remain physiologically dependent, not addicted.

Maryland Enacts Law Prohibiting Prior Authorization For Medications To Treat Opioid Addiction

• On May 25, 2017, Maryland Governor Larry Hogan (R) signed into law emergency legislation that prohibits insurers, nonprofit health service plans and health maintenance organizations from applying preauthorization requirements for medications used to treat opioid addiction (methadone, buprenorphine and naltrexone)• Prior authorization is a requirement from your insurance company to

your physician. The physician has to get specific medications (or procedures) approved by the insurance company before the insurance company will provide full (or any) coverage for them• This could be a matter of days or weeks before the medications can be

made available•

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There has been/still is(?) a bias by some clinicians in the field against

the use of medication

Until recently (and sometimes still) it also included the use of

psychiatric medications

The Genesis of Counselor Objection

•Early physician ignorance•The 70’s benzodiazepine “cure” • If you are on methadone, “you’re still addicted”•Morphine as a non-addictive treatment for opium dependence; heroin as a non-addictive treatment for morphine dependence; methadone as a non-addictive treatment for heroin dependence• General resistance to change• “Why can’t we do it the way we always have?”• Anxiety about trying something new they may not understand or be comfortable with

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To ignore the research does not

change the facts.

Good News – Bad News

• Pharmacotherapy can assist patient achieve abstinence• BUT abstinence is only the first step in a recovery process•Whether because of abnormalities in brain chemistry, either

prior to use, or as a result of use, or co-occurring disorders, abstinence alone is no guarantee of continued recovery

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Good Advice for Providers

We Can Provide More Cost-Effective Treatment

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There is light at the end of the tunnel