Use of Buprenorphine in the Management of Opioid Dependence in

Underserved Communities.

David Best, D.O.

Best Medical

Services, PLLC

2-27-13

Family Practice and Addiction Medicine Experience

I Attended Outpatient Based Opioid Treatment (OBOT) Course at AOA Conference in Fall 2004 while a senior family practice resident at Garden City Hospital.

Received waiver to prescribe buprenorphine and started managing patients with opioid dependence under supervision of Dr. Howard Wright at Dearborn Family Clinic.

Moved to Northern Michigan in 2005 and practiced full-time at Bellaire Family Health Center until Fall 2012. Started in private practice in Fall 2012.

Opioid Dependence and Addiction

Defies stereotyping

Review of 725,679 UDS from individuals 50

and over:

– 28.1% of UDS contained non-prescribed drug

– 31.8% of UDS where prescribed drug was not

detected

– 7.6% contained illicit drug – R. Frei. Study: Potential Medication Misuse in Older Pain

Patients. Pain Medicine News. Aug 2012.10-8:1,16.

General Categories at risk

Chronic pain patients who end up mis-using

opioids

Professionals: Doctors, Nurses, Pharmacists

who have access to medications

Recreational use of prescription drugs or use

of illicit drugs.

A Disturbing Trend in Northern Michigan

Percent of Admissions for substance abuse

treatment by substance

– 1997 75.2% alcohol, 1.5% opioids

– 2004 64% alcohol, 10.7% opioids

– 2010 52.6% alcohol, 25.9% opioids

Data from Northern Michigan Substance Abuse Services

(NMSAS) update

OBOT

Office Based Opioid Treatment

FDA approved the use of buprenorphine in the

treatment of opioid dependence in 2002.

Alternative to Methadone maintenance clinics

Increase from 20,000 patients receiving

buprenorphine in 2003 to 600,000 in 2009.

As of 2011 there are 19,500 physicians with

government waiver

Commitment to Improving Community by Providing OBOT

Reduce inappropriate prescribing

Improve access for treatment

Provide treatment for high-risk patients

Improved quality of life for patients and their families

– Less “driving all-over” trying to “score”

– The combination of opioid replacement plus counseling and/or 12-step programs allows patient to get their life in order

Potential Barriers to Care

Distance between home and clinic Between home and addiction counselor

Between addiction counselor and clinic

Lack of Motivation – Not ready for change in behavior

Lack of perceived confidentiality with AA or NA in a small community

Lack of providers providing affordable care

Buprenorphine

Suboxone: buprenorphine/naloxone

– Sublingual tablet or film (8/2mg or 2/0.5mg)

Subutex: buprenorphine

– Sublingual tablet (8mg or 2mg)

Pharmacology - buprenorphine

Mechanism: binds to opioid receptors

– partial mu receptor agonist

– delta receptor agonist

– Kappa receptor antagonist

Metabolism – CYP450; 3A4 substrate

Excretion – bile/feces 68%, urine 27%; ½ life

20-44 hours

Safety

Ceiling effect

– Agonist effect increases linearly until moderate dose

(16-32mg) and then reach a plateau.

– Higher dose unlikely to produce greater effect.

Lower risk of fatal overdose than full agonist

opiates.

Effective treatment because …

Partial mu receptor agonist that can hinder priming for opiates (lack of tolerance build-up)

Kappa receptor antagonistic properties that may improve dysphoric mood – “I feel normal again”

Easier induction than methadone

Greater access for patients than methadone maintenance clinics

– Fareed A. Effect of Buprenorphine Dose on Treatment Outcome. J Subst Abuse Treat 2012; 31:8-18..

Pharmacology - naloxone

Minimal absorption when delivered sublingual

or oral

Mechanism of action – opioid antagonist

Metabolism –liver

Excretion: urine; ½ life 64 minutes

Addiction

Is a disease, not a choice.

Common addictions Alcohol

Opioids

Benzodiazepines

Stimulants

Cocaine

Marijuana

Overeating?

The Limbic System

Group of interconnected deep brain structures,

common to all mammals, and involved in

olfaction, emotion, motivation, behavior and

various autonomic functions.

VTA and NA: Important Parts of Limbic System

Ventral Tegmental Area (VTA)

– Approx. 60% of neurons in this area are

dopaminergic

– Project to prefrontal cortex, caudal brainstem and

several regions in between

Nucleus Acumbens (NA) – pleasure center

Dopamine neurotransmission from VTA to NA

mediates reward properties of food, drugs, sex. – http://en.wikipedia.org/wiki/Ventral_tegmental_area

DSM IV Criteria For Opioid Dependence

– Maladaptive Pattern of opioid use leading to

clinically significant impairment or distress.

DSM IV Criteria for Dependence

– Also will have three or more of the following within a

12 month period:

Withdrawal syndrome if substance is stopped. Continued

use to prevent withdrawal

Tolerance – an increased amount needed to achieve

intoxication or diminished effect with continued use of the

same substance

DSM IV Criteria (cont)

Persistent desire or unsuccessful efforts to cut

down or control substance use

A great deal of time spent in obtaining the

substance, using the substance and in

recovering from effects

Social, occupational, and recreational activities

given up

And last but not least …

The substance use is continued despite

knowledge of having physical and

psychological problem that is likely caused by

the substance.

Clay SW: Risk Factors for Addiction. Osteopathic

Family Physician (2010) 2, 41-45.

Opioid Abuse – All the above plus

Have at least one of the following:

– Failure to fulfill major obligations at work, school, or

home

– Recurrent opioid use in hazardous situations

– Opioid related legal problems

– Social problems caused by or exacerbated by opioid

use

Change with DSM V (May 2013)

New classification for addiction problems:

Substance Use and Addictive Disorders

Defines more clearly that addiction is a brain

disease

– No longer will use labeling terms substance

depenence and substance abuse

– Potential to reduce guilt, shame, and stigma

associated with addiction and promote treatment

?Lack of recognition of problem.

Reluctance to treat addiction.

Not doing drug screens. Ignorance is bliss?

Importance of point of care testing

Opportunity to help patients (and families) who

are at great risk.

Treatment can be rewarding and challenging.

Cost Effective Treatment

– Opioid dependence treatment reduces illicit opioid

use and its associated health and social costs.

– Estimated every $1 invested in opioid dependence

treatment programs may yield a return of as much

as $12 due to:

Reduced drug-related crime, criminal justice costs

Health care savings – 2004 WHO/UNODC/UNAIDS position paper. Substitution maintenance

therapy in the management of opioid dependence and HIV/AIDS prevention.

Risk Factors for Addiction

Family

– Parents or siblings use

– Emotional, physical, or sexual abuse

Environment

– Poverty, Peer group use; opioids considered #1 “Gateway

Drug” (WHO document)

Individual

– Anxiety, Depression, ADHD, Poor school performance,

delinquency

Clay SW: Risk Factors for Addiction. Osteopathic Family

Physician (2010) 2, 41-45.

Risk Factor for Addiction: Sexual Abuse

Systematic review shows history of child

sexual abuse is a statistically significant risk-

factor.

Early traumatic experience may contribute to

other forms of psychopathology (PTSD for

example) that then increases risk of substance

abuse. – Maniglio R. The Role of Sexual Abuse in the Etiology of Substance

Related Disorders. J Subst Abuse Treat 2011; 30:216-228.

Get a Thorough History

Why now? In the patient’s words document

their motivations for starting treatment.

Severity and duration of substance abuse.

Environmental factors.

Family life, work life, education and goals.

Current or past involvement with the legal

system.

Patient Treatment Agreement

Review each item with patient.

Need to get commitment from them to:

– Show up for all appointments

– Establish with or continue with substance abuse

treatment program.

– Go to support group meetings: AA or NA

– Urine Drug Screens, pill counts.

Induction on buprenorphine

Typical starting dose is 8-16mg buprenorphine

daily.

Proper treatment will greatly reduce cravings

and provide emotional and physical relief in

patients

Now ready to start recovery

– Counseling and support groups necessary

component of treatment

Gradual Dose Reduction

Within 3-6 months, patient may be ready.

Within 12 months, solid recovery can be reality

and dose often 8-12mg daily.

Long term treatment: For patients with history

of opioid use of long duration and previous

failed abstinence based treatment. Typical

dose 2-12mg daily.

Long Term Treatment

Consider for patient who prior to treatment

have:

– Suffered an overdose

– Potential for loss of family, work, career if relapse

occurs

– Previous Incarceration for narcotic related offenses

“Healing The Addicted Brain”

By.Harold Urschel, MD (2009)

Recommend this book to your patients, to your

colleagues.

Case Studies

3 cases – 1. 34 year-old female with history of multiple pelvic surgeries

and started out on prescribed opioids 10+ years ago.

Struggling with addiction to methadone and heroin.

2. 29 year-old female, 13 weeks pregnant

3. 25 year-old male. More “typical” recreational drug user

(IVDA)

A, 34 year-old female

Seen first in July 2010.

Rx opiates for > 10 years.

– Methadone prescribed until 4 months ago.

Started using IV heroin 3 months ago

Last use of opiates – 3 days ago

Goal: “To not rely on methadone and to feel

normal”

Past Medical History

PMH – pelvic fracture at age 9; chronic pelvic

pain, depression

FH – brother died at age 15, nasopharyngeal

carcinoma; PGF-alcoholic

SH – Married, 2 kids; husband in prison (gets

out in 1 year)

Start OBOT

Suboxone 1/2 tab with elimination of withdrawl

symptoms. Total 1 tab today then 1 bid.

UDS – with methadone and alprazolam

metabolites as expected.

At follow-up four days later: no cravings for

opiates and feeling much better.

Very Motivated

Good participation in substance abuse

counseling: Weekly sessions at Catholic

Human Services

Medicaid approval for 12 months Suboxone.

Recovery

9 months later:

– Taking 1 tab daily.

– Feels isolated with husband still in prison. Financial stress.

Depressed.

– Started on Prozac 20mg daily with good results noted at f/u.

12 months later:

– Recently tapered to 1/2 tab daily.

– Regular exercise: walking, cycling, weights

– Happy that judgement no longer clouded from chronic opiate

use. Would like to continue taper.

Recovery

15 months later – Happy that her husband now also on OBOT

– Stable with ½ tab daily (she felt terrible when trying to taper further)

April 2012 (21 months in recovery) – Distraught over loss of job due to failure to disclose

felony conviction from 15 years prior

– Continues with counseling. She would like to be a mentor or counselor in the future.

Recovery Sustained

Appointments every 6 weeks

Husband (also in recovery) and 4 year-old son

come to every appt.

Now 31 months in recovery and dose is 1/3

film per day.

B, 29 year old pregnant female

Seen first in October 2011

Lives about 70 miles from clinic

13 weeks pregnant

IV Morphine 5 days ago

Prescribed opiates for back pain from 2002 to

2009

Severe cravings

Always worried about slipping up. Ashamed about track marks (admits to sometimes shooting up water due to cravings)

Wants to be able to provide stable home for her children and her fiancee

PMH – Hepatitis C

FH: F-alcoholic; sister: opioid abuse

Social – smokes 1ppd; works as a waitress; on probation now (was in jail for 9 months, got out 5 months ago.)

Early Remission

After 1 week

– Going for weekly counseling sessions and weekly

NA meetings

– Taking buprenorphine 8mg bid. Has cravings when

at work.

– UDS at court was positive for opiates; UDS in my

office +only for buprenorphine

Recovery

After 6 weeks

– Happy to be sober. Brighter affect and more

confident. Feels stable with 12mg daily.

– Had increase cravings after an argument with her

fiancee last week. Talking with her sponsor helped.

– Working full-time.

Success through pregnancy

At 37 weeks. OB visits going well. Denies

cravings with 6mg daily dose.

For about 6 months after delivery of healthy

baby girl she had regular follow-up and

consistent drug screens. I last saw her about 3

months ago.

Had probation violation and went to jail and has not

shown up for appointment at my new office.

H, 24 year old male

Seen first in June 2010

Was taking methadone 10mg 25 tabs daily

until 3 weeks prior. He went 3-4 days without

taking any and had successful induction on

Suboxone at another OBOT provider.

He has been going to NA meetings 2x/week

Sliding fee patient

– Unable to afford full prescription and relapsed after

first week

Switched to my practice due to sliding scale for

office visits and medications. He was paying

$150 per office visit.

Advised to start substance abuse counseling

More History

PMH – Alcohol abuse

FH – Brother(s),Father – substance abuse and

alcoholism

Social – Non-smoker

Occupation – Mason, general construction

A rather rocky start

After 6 weeks of weekly visits

– Continues to have alcohol binges and illicit opiate

use.

– Impaired driving conviction, 15 days in jail

– Near fatal over-dose

– Questionable friends coming with him to our health

center pharmacy

– Back to Detox.

Starting over

November 2010

– No longer wants to get high. Admits that in the past

would use Suboxone as a means to “avoid getting

sick”.

– Learned more about his addiction through his recent

detox.

– Realizes he needs to stay clean to stay alive.

Starting Over

Given Rx for Suboxone 2.5 tabs daily

Going to counseling at Harbor Hall twice per

week and to AA “as often as I can”

Has been exercising and feels better about

this.

Has his old job back

Supportive and responsible girlfriend

Slip-up after sustained remission

September 2011: Admitted to taking morphine on the 3-year anniversary of his older brother’s fatal car accident.

Resumed weekly visits for the next month. Increased frequency of counseling.

Has been on Suboxone for more than 28 months.

Last 15+ months with consistent drug screens

Common Challenges and Successes

Battle between trust and suspicion

Slip-ups vs. complete lack of recovery

Work towards getting better

Employed vs. Unemployed

Better family life

Thank You

“A great many people think they are thinking when they are merely rearranging their prejudices.”

“I will act as if what I do makes a difference.” William James (1842-1910)