Transcript HIV CONVERSION IN TREATMENT

Medication Assisted
Treatment (MAT)
in Pregnant Women
Susan F. Neshin, M.D.
Medical Director
JSAS Healthcare, Inc.
Asbury Park, NJ
E-mail: [email protected]
Overview of Presentation
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What is MAT?
Rationale for MAT
Importance of Dose Adequacy
Impact of MAT
The Medications
Women’s Issues/PREGNANCY
Addressing Stigma
What is MAT?
• MAT=Medication Assisted Treatment in context
of substance abuse treatment
• EUPHEMISM for opioid maintenance therapy
– Methadone
– Buprenorphine
• Broaden definition
– Naltrexone
– Medication for other drug dependencies
– Medication in the treatment of chronic disease
Medications Development
Division
• Branch of National Institute on Drug Abuse
(NIDA)
• Developing new medications
• Addiction as a brain disease
• Drug craving as a physiologic phenomenon
Rationale for MAT/OMT
For Chronic Opioid Dependence
• Dole’s concept of metabolic derangement
• Current concept of neuronal adaptations to
repeated exposures of the drug
• Pre-existing vulnerability and/or
consequence of opioid use
• Corrective, not curative
On/Off - Non-Tolerant Drug States
Overdose
“ON”
Intoxication
Drug Effect
Euphoria
“OFF”
No Drug Effect;
“Normophoria”
“Normal”
Dysphoria
Opioid Maintenance Pharmacotherapy - A Course for Clinicians
6
Dose Response
Heroin Simulated 24 Hr.
Dose/Response
With established heroin
“Loaded” tolerance/dependence
“High”
“Abnormal Normality”
Normal Range
“Comfort Zone”
Subjective
“Sick”
w/d
Objective w/d
0
hrs.
Time
24
hrs.
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Opioid Maintenance Pharmacotherapy - A Course for Clinicians
Dose Response
Methadone Simulated 24 Hr. Dose/Response
At steady-state in tolerant patient
“Loaded”
“High”
“Abnormal Normality”
Normal Range
“Comfort Zone”
Subjective
“Sick”
w/d
Objective w/d
0
hrs.
Time
24
hrs.
8
Opioid Maintenance Pharmacotherapy - A Course for Clinicians
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
addiction
Importance of
Dose Adequacy!
Recent Heroin Use by Current Methadone Dose
120
100
80
60
40
20
0
0
10
20
30
40
50
60
70
Current Methadone Dose mg/day
J. C. Ball, November 18, 1988
80
90
100
Retention in Treatment Relative to Dose
80 + mg
60-79 mg
< 60 mg
0
20
40
60
80
100
Adapted from Caplehorn & Bell - The Medical Journal of Australia
Impact of Maintenance Treatment
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Reduction death rates (Grondblah, ‘90)
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Reduction IVDU (Ball & Ross, ‘91)
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Reduction crime days (Ball & Ross)
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Reduction rate of HIV seroconversion
(Bourne, ‘88; Novick ‘90,; Metzger ‘93)
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Reduction relapse to IVDU (Ball & Ross)
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Improved employment, health, & social
function
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
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Impact of MMT on IV Drug Use for 388 Male
MMT Patients in 6 Programs
ADMISSION
100
*
*
0
Pre| 1st Year
Year
Admission
| 2nd Year
| 3rd Year
Adapted from Ball & Ross - The Effectiveness of Methadone Maintenance
Treatment, 1991
| 4th
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
HIV CONVERSION IN TREATMENT
25%
20%
15%
Tx Status
10%
5%
0%
In Tx (N=95)
Partial Tx
(N=45)
No Tx (N=55)
18 month HIV conversion by treatment retention
Source: Metzger, D. et. al. J of AIDS 6:1993. p.1053
OMT as Treatment of Choice
for Chronic Relapsing Opioid
Addict
• Concept of “prolonged abstinence”
– Hyper-reactivity to stress
– Dysphoria/craving increase vulnerability
to relapse
Relapse to IV drug use after MMT
105 male patients who left treatment
100
82.1
Percent IV Users
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
The Medications
• Methadone
– Long-acting full opioid agonist
– Orally effective
– Can be taken once a day
– Prescribed and dispensed at licensed
OTPs
The Medications
• Buprenorphine
– Approved by FDA in October, 2002
– Result of DATA 2000
– Long-acting partial opioid agonist
– Sublingually effective
– Can be taken once a day or less
frequently
– Prescribed by private practitioner with
waiver
The Medications
• Naltrexone
– Long-acting opioid antagonist
– Orally effective
– Can be taken once a day or less
frequently
– Benefits subgroups of opioid addicts
Addiction as a Biopsychosocial
Disease
• OMT addresses the biological aspect
• Psychosocial aspects addressed
– Substance abuse counseling
– Mental health treatment
– Support and self-help groups
• Accreditation standards
– Should improve treatment
– Eliminate “gas and go” model
Women’s Issues
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Higher levels of dual diagnosis than men
Childcare
Transportation
Domestic Violence
Educational/Vocational
Financial
Pregnancy
How to Address Women’s Issues
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Accreditation standards
Variable levels of resources
Women’s Set-Aside funds
One-stop shopping
Dual Diagnosis
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Depression/mood disorders
Anxiety disorders/PTSD
Eating disorders
Symptoms
– Guilt and shame
– Low self esteem
Dual Diagnosis
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Train counseling staff
Availability of therapist
Availability of psychiatrist
Staff with expertise in “survivor” issues
– Lifetime prevalence of drug abuse > 4
times greater in women who report
history of sexual assault
• Support/therapy groups
Childcare Issues
• Most women in treatment are of
childbearing age
• Children as barrier to treatment
• Services to address
– Children welcome
– On-site child care
– Parenting classes
Transportation Issues
• Lack of transportation as barrier to
treatment
• Clinics in “out of the way” areas
• Services to address
– Use of medical transportation for
Medicaid patients
– Site program close to public
transportation
– Give “take-homes” when earned
– Van service
Domestic Violence
• Train staff
• Facilitate referral to shelter when
appropriate
• Support/therapy group
Educational/Vocational Issues
• Most women in treatment are
“undereducated” and “underemployed”
• Services to address:
– Train staff about community
resources/state-funded programs
– On-site vocational counselor
– Address “sex for drugs” issues
Financial Issues
• Treatment is expensive
• Proprietary vs. publicly-funded non-profit
programs
• Services to address patient issues
– Accept Medicaid as payment
– Allow for reduced fee/indigency
– Counsel on budgeting
– Counselor referrals to/interventions with
local service agencies
Financial Issues
• Program issues
– Fund raising
– Lobbying for higher state/federal funding
Considerations for Treatment of
Pregnant Opiate Addict
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Tolerance level
Chronicity of use
Route of administration
Pregnancy history
Motivational level
Recovery environment
Ideal vs. Reality
OMT/MAT as Standard of Care
• Steady levels of opiates normalize
neuroendocrine functioning and prevent
fetal distress
• Decreases rates of pregnancy complications,
e.g. miscarriage, stillbirth, IUGR, abruptio
placenta, infection, hemorrhage
• Improves prenatal care
• Allows for psychosocial interventions to
improve level of functioning
Perinatal Addiction
• Importance of pregnancy testing at intake
• Priority admission should be given to
pregnant patients
• Family planning as counseling issue with
periodic pregnancy testing, especially
during medically supervised withdrawal
• Dose of methadone should be individually
determined and adequate to control craving
and prevent withdrawal syndrome
Perinatal Addiction
• MMT patients who become pregnant should
be continued at established dose. A midtrimester reduction may be appropriate in
anticipation of 3rd trimester dose increase.
• Altered pharmacokinetics during 3rd
trimester often require dose increases and
often a split dose to “flatten the curve” and
improve maternal and fetal stability.
Perinatal Addiction
• There is no consistent correlation between
maternal methadone dose and the severity
of neonatal withdrawal syndrome (Stimmel
et al., 1982).
• Protocols are available for scoring signs of
opioid withdrawal to guide the appropriate
use of medications to facilitate a safe and
comfortable withdrawal of the passively
addicted neonate (Finnegan, 1985).
Perinatal Addiction
• Breast-feeding may be encouraged during
MMT - if not otherwise contraindicated
(Kaltenbach, 1992).
• Multiple longitudinal studies find that
methadone-exposed infants score well
within the normal range of development
(Kaltenbach, 1992).
Perinatal Addiction
• Obstacles and barriers to MMT must be
removed for the pregnant patients.
• More research is needed on innovative
models of treatment including medically
supervised withdrawal during pregnancy
with residential care, intensive relapse
prevention and monitoring, high-risk
prenatal care. When appropriate hospitals,
clinics and individual obstetricians could
provide methadone maintenance.
Withdrawal during Pregnancy
Rarely appropriate during pregnancy (ASAM 1990)
• Same recidivism as non-pregnant opioid addicts
• Slow withdrawal between 14 and 32 week
Patient lives in an area where MM is not available.
Patient refuses to be placed on MM.
Patient has been stable and requests withdrawal
prior to delivery.
Withdrawal during Pregnancy
• No harm reduction with OMT
• Patient has been so disruptive to the
treatment setting that the treatment of other
patients is jeopardized, necessitating the
removal of the patient from the program.
Pregnancy
Comprehensive OMT with adequate
prenatal care can reduce the incidence of
obstetrical and fetal complications, in utero
growth retardation, and neonatal morbidity
and mortality (Finnegan, 1991).
Model Perinatal Program
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On-site prenatal care
On-site well-baby care
On-site child care
Educational groups
– Pregnancy/medical issues
– Methadone and pregnancy
– Effects of drugs of abuse, including
alcohol and nicotine, on fetus
Model Perinatal Program
• Educational groups--continued
– Nutrition
– Baby care
– Parenting skills--include fathers
– Contraception/Family Planning
– Domestic Violence
Model Perinatal Program
• Counseling on pregnancy termination and
adoption
• On-Site Psychiatric/Psychological
evaluation and treatment
Use of Psychotropic Medication
During Pregnancy
• Weigh risks vs. benefits
• Inform patient of drug’s potential for
teratogenic or other adverse effects
(Category)
• Consider consequences of untreated
psychiatric illness
• Use lowest effective dose
Antidepressants in Pregnancy
• No increase in major malformations
– ?cardiac defects with paroxetine
• No increase in long term neurodevelopmental
adverse outcomes
• SSRI’s in third trimester
– may see withdrawal syndrome in neonate
– increase in persistent pulmonary hypertension
– no long term residual effects
• Tricyclics relatively safe
• MAI inhibitors contraindicated
Benzodiazepines During
Pregnancy
• Slight increase in oral clefts
• Possible withdrawal syndrome
• No long term neurodevelopmental adverse
effects
Risks of Untreated Depression
• Increase in miscarriage, hypertension and
preeclampsia
• Increase in likelihood of relapse to
depression with stopping antidepressant
medication
• Global IQ negatively associated with
duration of depression
• Language development negatively
correlated with number of postnatal
depressive episodes
Addressing Stigma
• EDUCATE OURSELVES!
– “I don’t believe in methadone!”
– ASAM addressing physician bias
• Arizona study -- 96% refusal to treat or
give pain meds
• Example of physician opioid addict
Addressing Stigma
• EDUCATE OURSELVES!--continued
– Need to educate therapeutic
communities, Minnesota model
programs
– Need to educate Twelve Step community
• Methadone/buprenorphine as prescribed
medications rather than drugs of abuse
• Patients on OMT can work a program of
recovery
Addressing Stigma
• Educate service agencies and the general
public
– Arizona study -- 66% refused
employment or lost job
• Educate patients about the chronic disease
concept
– Methadone/buprenorphine as corrective,
not curative
• Educate family members
Addressing Stigma
• Publicly funded programs should be
mandated to accept patients on OMT
• Private programs should be encouraged to
accept patient on OMT
– Great need for residential
treatment/halfway houses for women
(pregnant or non-pregnant) and their
children
Addressing Stigma
• Patients should be encouraged to get
involved in advocacy
• Patients need to risk divulging status to
treatment providers with support from
program staff