Opioid Substition Therapy - California Opioid Maintenance
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Transcript Opioid Substition Therapy - California Opioid Maintenance
Methadone Maintenance in the
Treatment of Heroin Addiction
Prop 36 CLAIM Meeting - Oct 2003
Joan E. Zweben, Ph.D.
Executive Director: 14th Street Clinic and EBCRP
Clinical Professor of Psychiatry; University of California, San
Francisco
Questions & Issues
How important is methadone in treating
heroin addiction?
What is the rationale?
What is the data?
How do we decide when/if it can be
discontinued?
What is included in the psychosocial
component of treatment?
Natural History of Heroin Addiction:
A 33-Year Follow-up (1)
581 male heroin addicts, admitted to
Calif Civil Addicts Program, 1962-1964
CAP: compulsory drug tx for heroindependent criminal offenders
284 dead; 242 interviewed
High rates of disability, hepatitis,
excessive drinking, cigarette smoking,
marijuana use, other drug-related
problems
(Hser et al, 2001)
Narcotics Addicts: A 33-Year
Follow-up (2)
Between 1985-1986 to 1996-1997:
Dead: 49%
Abstinent: 20%-22%
Incarcerated: 4%-7%
Methadone maintenance: 2%-6%
Occasional use: 2%-3%
Lost to follow-up: 12
(Hser et al, 2001)
Opiate Dependency:
Hidden Populations
Subscribers of Private Insurance Plan:
Empire Blue Cross/Blue Shield, NYC
estimated from opiate dependency
diagnosis on admission & AIDS cases
insured 141,000 opiate users between
1982-1992
85,000 among current subscribers
(1992)
(Eisenhandler & Drucker, 1993)
Treatment Outcome Data:
Methadone
8-10 fold reduction in death rate
Reduction of drug use
Reduction of criminal activity
Engagement in socially productive roles;
improved family and social function
Increased employment
Improved physical and mental health
Reduced spread of HIV
Excellent retention
DEATH RATES IN TREATED AND UNTREATED HEROIN ADDICTS
8
7
6
5
OBSERVED
EXPECTED
4
3
2
1
0
MMT
VOL DC TX
INVOL DC TX
UNTREATED
Slide data courtesy of Frank Vocci, MD, NIDA - Reference: Grondblah, L. et al. ACTA
PSCHIATR SCAND, P. 223-227, 1990
Opioid Agonist Treatment of Addiction - Payte - 1998
Impact of MMT on IV Drug Use for 388 Male
MMT Patients in 6 Programs
ADMISSION
100
*
*
0
Pre| 1st Year
Admission
| 2nd Year
| 3rd Year
| 4th Year
Adapted from Ball & Ross - The Effectiveness of Methadone Maintenance Treatment, 1991
Opioid Agonist Treatment of Addiction - Payte - 1998
Relapse to IV drug use after MMT
105 male patients who left treatment
Percent IV Users
100
82.1
80
72.2
60
57.6
45.5
40
28.9
20
0
IN
1 to 3
Treatment
4 to 6
7 to 9
10 to 12
Months Since Stopping Treatment
Adapted from Ball & Ross - The Effectiveness of Methadone Maintenance Treatment, 1991
Opioid Agonist Treatment of Addiction - Payte - 1998
Crime among 491 patients before and during
MMT at 6 programs
Crime Days Per Year
300
250
200
Before TX
During TX
150
100
50
0
A
B
C
D
E
F
Adapted from Ball & Ross - The Effectiveness of Methadone Maintenance Treatment, 1991
Opioid Agonist Treatment of Addiction - Payte - 1998
HIV DISEASE
•
Role of MMTP
–
Education, counseling, and
testing -- prevention
–
Decrease HIV transmission by
decreasing needle sharing
–
For HIV (+) patients, provide, refer,
and coordinate treatment
Opioid Maintenance Pharmacotherapy - A Course for Clinicians - 1997
HIV CONVERSION IN TREATMENT
35%
30%
25%
20%
IT
OT
15%
10%
5%
0%
Base line
6 Month
12 Month
18 Month
HIV infection rates by baseline treatment status. In treatment (IT) n=138, not in
treatment (OT) n=88
Source: Metzger, D. et. al. J of AIDS 6:1993. p.1052
Opioid Maintenance Pharmacotherapy - A Course for Clinicians - 1997
OPIOID
MAINTENANCE
THERAPY
The Addiction Process:
Barriers to Understanding
INFLUENCE OF THE STIGMA:
difficulty understanding the complexity of
the disorder
treatment is denied
treatment is diminished
treatment is discouraged
treatment is conditional
“I Don’t Believe in
Methadone”
Methadone is a medication,
not a religion
J. Thomas Payte, MD
Founding Chair, Methadone Treatment
Committee, ASAM
Overview:
Opioid Maintenance Therapy
Methadone (MMT) & levoacetylmethadol
(LAAM), buprenorphine (soon)
most highly regulated
history
rationale for replacement therapy
political influences
diversion
OMT, Continued
Strong empirical support for safety and
efficacy (30 years of data)
valuable tool in reducing spread of HIV
makes the pt accessible to interventions
for other problems
hidden populations of heroin users
medical maintenance and office-based
practice
What is Abstinence?
Medication is compatible with 12-step
participation if appropriately prescribed by
physician knowledgeable about addiction
Pt on methadone is abstinent if not using illicit
drugs and using legal ones as prescribed
It’s just another medication. Meds are a tool,
not a solution
Dole: Receptor System
Dysfunction
Endogenous ligand-narcotic receptor system is
defective; hence high relapse rate
Stabilize blood level at 150-600 ng/mL
This normalizes neurological and endocrine
functioning
This treatment is corrective but not curative
Future research: identify the specific defect and
repair it
(Dole, JAMA 1988)
Genetic Factors
Recent studies show distinct genetic
vulnerability to heroin and other opiates:
heroin had larger genetic influences unique to
itself than marijuana, sedatives, stimulants,
psychedelics (Tsuang et all; Merikangas et al; ARCHIVES 1998)
Alcoholism and drug disorders appear to be
independent
Genetic factors impact the transition from drug
use to abuse/dependence, not use itself
Diversion of Medication
political hot button
key issue in formulating original regs
IOM report: cannot document significant
public health or safety problem
confusion about DAWN data
difficulty of determining cause of death
(Rettig 1995)
Reasons for Diversion
selling take-homes to buy illicit drugs
need to supplement income
share with or sell to addicted friend/mate
unwilling or unable to enter treatment
low dose policies of some programs
IOM conclusion: risks of diverted methadone do not
outweigh benefits of making MMT more available
(Rettig 1995)
PHARMACOTHERAPY
Methadone vs Heroin
Can be taken by mouth
Slow onset of action
No continuing increase in tolerance levels
after optimal dose is reached; relatively
constant dose over time
Pt on stable dose rarely experiences euphoric
or sedating effects; is able to perceive pain
and have emotional reactions; can perform;
can perform daily tasks normally and safely
Methadone vs Heroin (2)
Long acting; prevents withdrawal for 2436 hours (4x-6x as long as heroin),
permitting once-a day-dosing
At sufficient dosage, blocks euphoric
effect of normal street doses of heroin
Medically safe when used on long-term
basis (10 years or more)
(Physician’s Guide: Opioid Agonist Medical Maintenance Treatment; CSAT
2000)
Heroin Simulated 24 Hr. Dose/Response
Dose Response
With established heroin tolerance/dependence
“Loaded”
“High”
“Abnormal Normality”
Normal Range
“Comfort Zone”
Subjective w/d
0 hrs.
“Sick”
Objective w/d
Time
Opioid Agonist Treatment of Addiction - Payte - 1998
24 hrs.
GOALS FOR PHARMACOTHERAPY
• Prevention or reduction of withdrawal symptoms
• Prevention or reduction of drug craving
• Prevention of relapse to use of addictive drug
• Restoration to or toward normalcy of any
physiological function disrupted by drug abuse
Source: MJ Kreek, Rationale for Maintenance Pharmacotherapy of Opiate
Dependence, 1992
Opioid Agonist Treatment of Addiction - Payte - 1998
PROFILE FOR POTENTIAL
PSYCHOTHERAPEUTIC AGENT
Effective after oral administration
Long biological half-life (>24 hours)
Minimal side effects during chronic
administration
Safe, no true toxic or serious adverse effects
Efficacious for a substantial % of persons with
the disorder (> 15-20%)
Source: MJ Kreek, Rationale for Maintenance Pharmacotherapy of Opiate
Dependence, 1992
Opioid Agonist Treatment of Addiction - Payte - 1998
Dose Response
Methadone Simulated 24 Hr. Dose/Response
At steady-state in tolerant patient
“Loaded”
“High”
“Abnormal Normality”
Normal Range
“Comfort Zone”
Subjective w/d
0 hrs.
“Sick”
Objective w/d
Time
Opioid Agonist Treatment of Addiction - Payte - 1998
24 hrs.
“Not Holding” Strategies
Cognitive,
Behavioral Interventions
Increased contact, counseling,
therapy
Alter urinary pH?
Is patient fixing? - Raise dose
Split Dose?
Payte - Khuri
Opioid Agonist Treatment of Addiction - Payte - 1998
Rapid Metabolizer - High Single and
Split Dose Simulation
700
Single
600
High
High
Single
ng / ml
500
400
Split Dose
Normal
300
Minimum
200
Sick
'Normal'
Ceiling
100
0
0
4
8
12
16
20
Hours
Payte
Opioid Agonist Treatment of Addiction - Payte - 1998
24
TAPERING
how many remain abstinent?
tapering readiness
tapering strategies
clonidine
handling relapse
Buprenorphine (1)
1970’s - partial opioid agonist useful in
opioid dependence treatment
1990’s - clinical trials
long duration of action; smooth onset
low physical dependence
mild withdrawal syndrome
good name on the street
Buprenorphine (2)
DATA 2000 permitted use in MD office
FDA approved Subutex and Suboxone in
2002
Physicians must meet training
requirements: certified in addiction
medicine, participated in clinical trials, or
took 8 hour course by specified
organizations
Buprenorphine (3)
SUBUTEX & SUBOXONE
Sublingual tablets
Suboxone has naloxone added to
discourage needle use
Partial agonist: ceiling effect
Expensive: $300/month at average dose
Not interchangeable with methadone
Buprenorphine (4)
Poor oral bioavailability
Sublingual administration requires
longer observation
Abuse documented in Europe, Australia,
and New Zealand
How much training should be required
for physicians to use it?
Naltrexone
antagonist; how it works
who does it work for?
accelerated withdrawal protocols
Dole’s critique
utility with alcoholics
Methadone in Pregnancy
Comprehensive MMT treatment with prenatal
care improves neonatal outcome
Withdrawal is rarely appropriate during
pregnancy
Methadone is not teratogenic; children have
been followed into adulthood
Appropriate dosing is very important
Breast feeding OK if no other drug use
Opioids and Chronic Pain
Opioid tolerance & physical dependence DO
NOT equal opioid addiction
Loss of Control Indices:
» Continued use despite adverse consequences
» Illicit or inappropriate drug seeking behavior
– In response to craving or drug hunger
– In the absence of pain or withdrawal
Pseudo Addiction
- in chronic pain patient
Inadequate Treatment of Pain
“Apparent” Drug Seeking Behavior
» Effort to achieve adequate analgesia
» Early refill, doctor shopping, etc.
– Manipulation seen as “addictive behavior”
– May be seen as non-compliance
“Cured” by adequate treatment of pain
Opioid Agonist Treatment of Addiction - Payte - 1998
Chronic Pain Disorder
Opioid Tolerance
Opioid Physical Dependence
Absence of illicit or inappropriate drug
seeking behavior
» No drug hunger in absence of pain
» No loss of control
No “doctor shopping”
Little tendency to escalate dose over time
Opioid Agonist Treatment of Addiction - Payte - 1998
PSYCHOSOCIAL
TREATMENT ISSUES
Population Characteristics
Heterogeneity
Readiness for recovery; motivation
Psychiatric comorbidity
Medical comorbidity
Program Characteristics
Medical component: assessment,
dosing, client interactions
Individual counseling
Group counseling
Case management
Staff training (ongoing)
What is Abstinence?
Medication is compatible with 12-step
participation if appropriately prescribed by
physician knowledgeable about addiction
Pt on methadone is abstinent if not using illicit
drugs and using legal ones as prescribed
It’s just another medication. Meds are a tool,
not a solution
Cognitive-Behavioral Therapy
Lends itself to controlled studies; strong
support for its effectiveness
Especially useful to help establish
abstinence, teach early recovery and
relapse prevention skills
Emphasizes changing behavior and
managing symptoms
Cognitive Behavioral Strategies
(CBT)
MATRIX MODEL - Organizing Principles
Create explicit structure and expectations
Establish positive, collaborative relationship
Teach information and CBT concepts
Positively reinforce behavior change
Provide corrective feedback when necessary
Encourage self-help participation
CBT: MATRIX MODEL
Structure is essential: time scheduling, selfhelp meetings, exercise, work, treatment
activities
Identify external and internal triggers and
make a plan
Tools for managing cravings: thought
stopping, visual imagery, change
environment/behavior
TIP #33 has description, patient worksheets
(Rawson 1999)
Clinical Issues
Is Psychotherapy Useful?
Philadelphia group study, begun 1977
global psychiatric status ratings
elements of drug counseling
models of psychotherapy utilized
benefits to low severity patients
benefits to high severity patients
Dual Diagnosis Issues
depression
trauma history; PTSD
schizophrenia
medication strategies
PTSD Influence in Early Tx
Aim: determine tx adherence relative to
frequency of violence and PTSD in MMT pts,
male & female
96 pts; over 2/3 exposed to one or more violent
traumatic events
Trauma or PTSD did not predict dropout rates
Those with current PTSD had significantly more
ongoing drug use at 3 months, especially
cocaine
(Hein et al, 2000)
Continued heroin, alcohol,
and other drug use
patient and provider expectations
enhancing motivation
cocaine use
alcohol use
medical comorbidity; AIDS, chronic pain
controversies about discharge
Psychological Issues
AOD use in family of origin
high frequency of childhood physical
and sexual abuse
recognition and appropriate expression
of feelings
issues of self-care, self-soothing
Women’s Issues
remove practical barriers: transportation,
child care
intimate relationships as primary hazard
sexual issues
contraceptive practices
Family/Couples Work
engaging family, significant others
education about addiction and MMT
develop existing and new support
structures
couples issues
parenting classes
HIV/AIDS
impact on MMT staff; providing support
regular assessment of staff attitudes and
knowledge
integrating primary care
promoting medication compliance
impact of dementia on treatment
MMT and 12-Step Programs
benefits and hazards
simulated meetings as a launching
strategy
meetings in the community
Vincent Dole and Bill W.
other types of self-help
advocacy groups
Making Residential Treatment
Available to Methadone Patients
Some clients need higher level of care
Issues for the methadone program
Issues for the residential program
Security issues
Documentation issues
Funding barriers