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Treatment of opioid dependence during pregnancy
Judith Martin, MDMedical DirectorThe 14th Street Clinic, Oaklandwww.14thstreetclinic.org
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In a nutshell: - context of medication-assisted addiction treatment. -Use of methadone and of buprenorphine in pregnancy and in the postpartum period.
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Models of addiction treatment
Recovery
Psychodynamic Behavioral
Spiritual
Medical
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ADDICTION AS A CHRONIC ILLNESS
Chronic relapsing condition which untreatedmay lead to severe complications and death.
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ADDICTION AS CHRONIC DISEASE: IMPLICATIONS• It is treatable but not curable.• Adjustment to diagnosis is part of
patient’s task. • There is a wide spectrum of severity.
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ADDICTION AS CHRONIC DISEASE, CONT.:• Retention in treatment is key.• Behavior changes needed.• Adherence around 30%, like asthma,
diabetes, hypertension.
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The 14th Street Clinic
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THE DOSING WINDOW
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Counseling Staff
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Medical Staff
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Do
se R
esp
on
se
Time
“Loaded” “High”
Normal Range“Comfort Zone”
“Sick”
Methadone Simulated 24 Hr. Dose/ResponseAt steady-state in tolerant patient
0 hrs.
24 hrs.
Subjective w/d
Objective w/d
Opioid Agonist Treatment of Addiction - Payte - 1998
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Number of new non-medical users of therapeutics
(NSDUH, 2002)
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Do
se R
esp
on
se
Time
“Loaded” “High”
Normal Range“Comfort Zone”
“Sick”
Methadone Simulated 24 Hr. Dose/ResponseAt steady-state in tolerant patient
0 hrs.
24 hrs.
“Abnormal Normality”
Subjective w/d
Objective w/d
Opioid Agonist Treatment of Addiction - Payte - 1998
trough
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What is the right dose?
• Eliminate physical withdrawal• Eliminate ‘craving’• Comfort/function: usually trough is 400-600
ng/ml, peak no more than twice the trough.• Not oversedated• Blocking dose
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“How Much????
Enough!!!”Tom Payte, MD
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Recent Heroin Use by Current Methadone Dose
0
20
40
60
80
100
0 10 20 30 40 50 60 70 80 90 100
Methadone Dose, in mg.
% H
eroi
n U
se
Ref: J. C. Ball, November 18, 1988Slide adapted from Tom Payte
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Medication-assisted treatment (MAT) for addiction during pregnancy
• Most evidence is related to heroin addiction vs. methadone maintenance.
• Relapse is the main practical issue.
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PREGNANCY AND OPOID ABUSE• Considered a “high risk” pregnancy.• Medication: Both intake and withdrawal have fetal
effects. Withdrawal effects considered more serious.
• Psychosocial: High motivation to change, guilt about being a ‘bad mother.’
• Legal: implications related to parenting and custody.
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Possible Neonatal effects of heroin• Low birth weight• Meconium aspiration (fetal stress)• STDs• Neonatal withdrawal syndrome (60-80%)• Delayed effects, 4-6mos (jittery)• No effect
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METHADONE AND PREGNANCY
• Improvement in outcomes overall over heroin.
• Fetal growth more normal than with heroin• Perinatal mortality less than with heroin• NAS predictable and at least 45% need
treatment• Breastfeeding OK
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NEONATAL WITHDRAWAL (NAS, NWS) with MMT. • Predictable, usually within 72 hours of birth• Treatable, opiates vs phenobarbital, etc• Monitor for spasms/seizures• May have trouble gaining weight at first• Normal development after first year• Not dose-related, split dose may be helpful.
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Baby at bedside: not likely
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Maternal visits are the norm
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Pregnant women and MMT: • Admission is expedited• May be admitted even without current physical
dependence• Monitoring requirements intensified• Education about NAS, and about avoiding
withdrawal during pregnancy• Education about other substances.
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TALKING WITH PREGNANT PATIENTS about MMT• Fear about methadone• Dose-related issues• CPS, legal issues• Self-concept and hormones• Parenting• Polysubstance abuse
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Medical facts for pregnant patients on MMT• Good overall pregnancy outcomes with
maintenance. • Avoid withdrawal during pregnancy, some
women need split doses.• NO NUBAIN during labor! (partial agonist
anesthetic)• Neonatal withdrawal is treatable
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Coordination of care: when the delivery happens• Hospital calls OTP clinic nurse to document current
methadone dose, and last date and time of ingestion. • Usually regular daily dose is maintained.• Patient discharged with documentation of last dose:
mg, date and time dispensed, and any home medications, to bring to the clinic the next day
• Clinics open 365, but may have limited hours.
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What is a good outcome for MAT in pregnancy? • Maternal abstinence during pregnancy, with steady
blood levels of methadone. • Regular prenatal visits with clinician who knows about
MAT and methadone.• Attention to surrogate markers of fetal withdrawal
(increased motion, maternal craving or withdrawal)• Baby stays at least 5 days, NAS controlled.• Mother continues MMT after delivery, dose may
decrease, may breastfeed.
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Example of good outcome:
• McCarthy et al: Am J Obstet Gynecol, September 1, 2005; 193(3 Pt 1): 606-10.
High-dose methadone maintenance in pregnancy: maternal and neonatal outcomes.
Retrospective case series of 81 women on MMT in Sacramento.
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McCarthy et al, cont
• Average maternal dose 101mg, most of them split dosing.
• 81% negative toxicologies at birth• 45% treated for NAS• Subgroup with best outcome was women
already on MMT who became pregnant.
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MAT and pregnancy, options:• Methadone maintenance is the current treatment of
choice for pregnant opioid addicted women• Limited studies suggest that buprenorphine may be
useful, possibly even reducing neonatal withdrawal days (partial agonist).
• No information about prescription drug abusers (one warning about OxyContin causing NAS)
• Detoxification or Medically Supervised Withdrawal (MSW) requires monitoring, usually done in second trimester.
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Don’t prescribe narcotics to an addicted person EXCEPT:• Within the Opioid Treatment Program
(specially licensed, AKA methadone clinic)
• Under Drug Addiction Treatment Act of 2000 (office-based use of buprenorphine)
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Buprenorphine
• New formulation of a partial mu agonist, in sublingual tablets.
• New legislation (DATA 2000) enabling office opioid maintenance treatment with some restrictions.
• Suboxone® combined with naloxone to discourage injected abuse
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Comparison of Activity Levels
0
10
20
30
40
50
60
70
80
90
100
% Mu Receptor
IntrinsicActivity
Full Agonist
(e.g. methadone)
Partial Agonist
(e.g. buprenorphine)
Antagonist (e.g. naloxone)
no drug high dose
DRUG DOSE
low dose
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Por cortesía de Reckitt Benkiser
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Buprenorphine and pregnancy• Case series in France: safe and effective, possibly
reducing NAS• One preliminary study in US:Jones et al; Drug Alcohol Depend, July 1, 2005;
79(1): 1-10. Buprenorphine versus methadone in the
treatment of pregnant opioid-dependent patients: effects on the neonatal abstinence syndrome.
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Jones et al, 2005, cont
• Head to head randomized blinded comparison between methadone and buprenorphine in pregnant women
• Women admitted during second trimester• One statistically significant finding: shorter stay for
bup• Other trends for bup: fewer infants treated for NAS,
less NAS medication used. • Multi-site trial in progress now.
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Practical considerations about buprenorphine and pregnancy• Labeled category C (not enough information) • Probably better to use mono product • Informed consent for legal reasons• Label says no breastfeeding, but probably safe (
not orally very bio - available)• In the initial survey of use of buprenorphine,
women with prescription opioid abuse were a significant population.
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What about detoxification and MSW? • First and third trimester generally considered
more dangerous• Studies show if inpatient, monitored can
technically be achieved safely• Practical consideration is relapse.
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Summary: Opioid addiction and pregnancy• Methadone maintenance is still the treatment of
choice and standard of care in the US. • Buprenorphine treatment is possible, evidence
still lacking. • Detoxification is relatively contraindicated unless
done in hospital with monitoring.