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Innovative Methods for

Addressing Substance Use in

Pregnancy

Grace Chang, MD, MPHProfessor of Psychiatry, Harvard Medical School

VA Boston Healthcare System

Tuesday, October 23, 2018

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Disclosures

• Royalty payments for 2 chapters from Up to Date

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Target Audience

• The overarching goal of PCSS is to train a diverse

range of healthcare professionals in the safe and

effective prescribing of opioid medications for the

treatment of pain, as well as the treatment of

substance use disorders, particularly opioid use

disorders, with medication-assisted treatments.

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Educational Objectives

• At the conclusion of this activity participants should

be able to:

▪ Identify which types of substances are most

problematic.

▪ Review what has been a transformative

development in the identification and modification

of prenatal substance use.

▪ Examine what areas need further research.

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What is the magnitude of

prenatal exposure?

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Prevalence of Prenatal Substance Use

• Legal substances are the most problematic in terms

of effect and magnitude

▪ Alcohol (18% in the first trimester)

▪ Cigarettes (15.4%)

▪ Prescription opiates (<2.5%*)

• Illicit substances are less common and less

problematic (5.4%)

▪ Marijuana, Cocaine, Heroin

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Alcohol is a Known Teratogen

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Fetal Alcohol Spectrum Disorders

• Caused by prenatal alcohol use

• No known amount of alcohol that is safe

• No safe kind of alcohol to drink

• No known safe time to drink

• Half of all US pregnancies are unplanned

• Prevalence Rates

▪ FAS, .2 to1.5 children per 1000 live births

▪ FASD, three times the FAS rate

▪ 1 in 100 children are born with some exposure to

alcohol

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Prenatal Cigarette Smoking

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Prenatal Cigarette Exposure:

Pregnancy Complications

• Pregnancy complications

• Ectopic pregnancy

• Placenta previa

• Prematurity

▪ Decreased birth weight, birth length, head

circumference

• Intrauterine death

▪ Sudden infant death syndrome

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Effects on CNS Development,

Cognitive Function, & Behavior

• Disturbed maternal

infant interaction

• Excitability

• Hypertonia

• Stress abstinence

signs

• Reduced IQ

• Aggression

• Conduct disorder

• Antisocial behavior

• Impulsivity

• ADHD

• Tobacco use and

dependence

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Illicit Substances, Including Non-

Medical Use of Prescription RX

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Specific Illicit Drug Dependence or

Abuse, Aged 12 or Older

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Prenatal Marijuana Use

• Fetal growth restriction

• Attentional deficits

• Other neurodevelopmental

effects

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Screening and Brief

Intervention

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Transformative Development

• Pregnant women are ideal recipients

▪ Highly motivated to change behaviors

• Screening

▪ Assess substance use and its severity

• Brief Intervention

▪ Increase motivation to change [reduce or abstain]

• Referral to treatment

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Examples

• Prenatal clinic, including their partners

▪ Chang et al., 2005

• PHFE-WIC program

▪ O’Connor & Whaley, 2007

• Early Start program at Kaiser Permanente NC

▪ Goler et al., 2008

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Identification of Prenatal

Substance Use

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Some Challenges

• Patients are reluctant to disclose alcohol or other

substance use

▪ Fear of stigma or sanction

• Biological tests of exposure

▪ Urine, hair, breath

▪ Need informed consent

• Limitations of biological tests

▪ Measure recent exposure (alcohol)

▪ None clearly superior

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Questionnaires

• Offer many advantages

▪ Quick, inexpensive

▪ Well studied for prenatal alcohol exposure

• Major disadvantage

▪ Lack a validated measure that reflects current

patterns of use, including multiple substances

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A Multi-Site Comparison of Five Self-Report

Screening Questionnaires for Substance

Use in Pregnancy

Centers for Disease Control and Prevention,

5R21DP006082-02 (PI: K. Yonkers)

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Purpose

• Evaluate 5 promising screening tools that might be

given to pregnant women

▪ 5Ps

▪ SURP-P

▪ Crafft

▪ WIDUS

▪ NIDA Quick screen

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5 Ps Screener: Yes to Any is Positive

5P1

Did any of your parents have a problem

with alcohol or drug use?

5P2

Do any of your friends have a problem

with alcohol or other drug use?

5P3

Does your partner have a problem with

alcohol or drug use?

5P4

Before you were pregnant, did you have a

problem with alcohol or drug use?

5P5

In the month before you knew you were

pregnant, did you drink any beer, wine, or

liquor, or use other drugs

Ewing, 1990. Born Free Project

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Substance Use Risk Profile-Pregnancy

Yes/No 0=LOW RISK 1=MODERATE RISK 2-3=HIGH RISK

SURP-P1 Have you ever smoked marijuana?

SURP-P2

In the month before you were pregnant, how

many beers, how much wine, or how much

liquor did you use?

SURP-P3

Have you ever felt that you needed to cut down

on your drug or alcohol use?

0= low risk; 1=moderate risk; 2-3 high risk

Yonkers et al, Obstet & Gynecol, 2011

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CRAFFT: >2 is Considered Positive

CRAFFT1 C

Have you ever ridden in a car driven by someone

(including yourself) who was "high" or had been

using alcohol or drugs?

CRAFFT2 R

Do you ever use alcohol or drugs to relax, feel better

about yourself, or fit in?

CRAFFT3 A

Do you ever use alcohol or drugs while you are by

yourself, alone?

CRAFFT4 F

Do you ever forget things you did while using alcohol

or drugs?

CRAFFT5 F

Do your family or friends ever tell you that you should

cut down on your drinking or drug use?

CRAFFT6 T

Have you ever gotten into trouble while you were

using alcohol or drugs?

Knight, Arch Pediatr Adolesc Med, 2002

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Wayne Indirect Drug Use Screener > 3 is considered positive

CRAFFT1 C

Have you ever ridden in a car driven by someone

(including yourself) who was "high" or had been

using alcohol or drugs?

CRAFFT2 R

Do you ever use alcohol or drugs to relax, feel better

about yourself, or fit in?

CRAFFT3 A

Do you ever use alcohol or drugs while you are by

yourself, alone?

CRAFFT4 F

Do you ever forget things you did while using alcohol

or drugs?

CRAFFT5 F

Do your family or friends ever tell you that you should

cut down on your drinking or drug use?

CRAFFT6 T

Have you ever gotten into trouble while you were

using alcohol or drugs?

Ondersma et al, Addiction 2012

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NIDA Quick Screen

NIDA Resource Guide: Screening for Drug Use in General Medical Settings;

In the past month*, how often have you used

the following?

NIDA1 4 or more drinks per day?

NIDA2 Tobacco products?

NIDA3 Prescription drugs for non-medical reasons?

NIDA4 Illegal drugs?

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Methods

• 1220 pregnant women

▪ 3 sites: New Haven, Boston, Detroit

• Phase 1

▪ Complete the 5 questionnaires given in

counterbalanced order

• Phase 2

▪ Diagnostic interview

▪ Timeline follow-back interview for the past 30

days

▪ Urine Toxicology screen

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Results

Self-Report/Urine Toxicology Screen

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Participant Characteristics

Characteristic MGH WSU Yale

Age in years (mean,sd) 32.6 (4.4) 26.1 (5.1) 28.7 (6.1)

Race

Non-Hispanic Black 6.9% 84.1% 38.9%

Non-Hispanic White 71.2% 4.8% 33.4%

Hispanic 11.1% 3.6% 25.5%

Mixed/Other 1.8% 6.3% 4.0%

Education

<High School 0.9% 17.1% 11.6%

High School/GED 5.1% 34.5% 37.4%

Some College or Higher 94.0% 48.4% 51.0%

Married/Cohabitating (Yes) 91% 17% 41%

Public Assistance (Yes) 12.6% 70.9% 47.1%

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Participant Characteristics

Characteristic MGH WSU Yale

Trimester

First 26.4% 47.7% 33.0%

Second 35.1% 27.0% 33.8%

Third 38.4% 25.2% 33.2%

Positive Urine or Self Report

Alcohol 13.2% 18.9% 6.9%

Tobacco/Cotinine 3.9% 27.0% 17.7%

THC 3.3% 29.4% 13.7%

Opiates 2.7% 4.9% 4.0%

Illicit drugs other than THC 3.3% 5.7% 6.1%

Any Substance 18.6% 48.1% 31.6%

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Alcohol

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Tobacco

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Illicit Substances

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Any Substances

37.5

40.8

70.6

78.8

80.1

82.5

97.0

0 20 40 60 80 100

SURPP-moderate

5 P's

SURPP-high

NIDA-pre-pregnancy

CRAFFT

WIDUS

NIDA

Specificity

34.9

44.5

50.9

52.4

63.4

79.2

84.7

0 50 100

CRAFFT

NIDA

SURPP-high

WIDUS

NIDA-pre-pregnancy

5 P's

SURPP-moderate

Sensitivity

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Any Substances

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Any Substances Except for Tobacco

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Results

MINI Diagnostic interview 6.0

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Frequency of Diagnoses by Site

Diagnosis Overall MGH WSU YALE

AUD 5.7% 6.7% 9.3% 2.9%

SUD 6.1% 2.1% 10.2% 6.0%

AUD OR

SUD

9.6% 7.3% 15.4% 7.4%

AUD & SUD 7.1% 5.8% 11.2% 5.4%

CANNABIS 5.2% 1.5% 9.6% 4.7%

STIMULAN

T

1.0% 0.6% 0.9% 1.3%

RX, NON –

MEDICAL

0.4% 0.3% 0.3% 0.5%

HEROIN 0.4% 0.3% 0.3% 0.5%

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Alcohol Dependence or Abuse

Sensitivity Specificity Accuracy

SURPP-high 87% 66% 68%

SURPP-moderate 98% 32% 36%

CRAFFT 80% 79% 79%

WIDUS 59% 73% 72%

Five Ps 94% 36% 39%

NIDA 35% 85% 82%

NIDA-alcohol 6% 98% 92%

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Substance Dependence or Abuse

Sensitivity Specificity Accuracy

SURPP-high 77% 66% 67%

SURPP-moderate 100% 32% 36%

CRAFFT 62% 78% 77%

WIDUS 72% 74% 74%

Five Ps 96% 36% 40%

NIDA 54% 86% 84%

NIDA-substance 36% 95% 92%

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Either AUD or SUD

Sensitivity Specificity Accuracy

SURPP-High 80% 68% 69%

SURPP-Low 99% 33% 40%

CRAFFT 69% 80% 79%

WIDUS 63% 75% 74%

Five Ps 96% 38% 43%

NIDA 44% 87% 83%

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Conclusions

• Prenatal substance use is common

▪ Protective effect of pregnancy on risk for substance use

• DSM IV Diagnoses , ~7 to 15%

• Rates for recent use, 18 to 48%

▪ Diverse participant sample

▪ Anonymous

▪ Estimates are based on urine toxicology screens and self-report

• Head to head comparison of screening measures

▪ There is room for improvement!

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Brief Interventions

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Core Components

• 4 core components

− Assessment and Feedback

− Goal Setting and Contracting

− Behavioral Modification

− Written Materials

▪ Reduce drinking in nondependent drinkers

▪ US Preventive Services Task Force Grade B

recommendation to reduce alcohol misuse in

adults, including pregnant women, in primary

care settings

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Implementation

• Not universal, despite recommendations otherwise

▪ Time limitations

▪ Privacy and mandated reporting

▪ Competence /ability of the clinician

▪ Innovative approaches

• TECHNOLOGY

▪ CBT4CBT

▪ Computer based technology for cognitive

behavioral therapy

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A RCT of Screening and Brief Interventions

for Substance Misuse in Reproductive

Health

Martino, Ondersma, Forray, et al., 2018

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Purpose

• To determine whether “screening, brief intervention,

and referral to treatment” that is delivered either

electronically or by clinician are more effective than

enhanced usual care in decreasing days of primary

substance use

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Study Design

• Women from 2 reproductive centers who smoked cigarettes or misused alcohol, illicit drugs, or prescription medications

▪ Urn randomization to one of 3 conditions:

▪ 1) E-SBIRT

▪ 2) Clinician delivered SBIRT

▪ 3)Educational pamphlet + treatment as usual

• Assessments completed at baseline, 1-, 3-, and 6-months after the baseline

• Co-primary outcomes

▪ Days/months of primary substance use

▪ Post intervention treatment use

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Results

• 2421 women approached for screening, 439 randomized

▪ Women who were seeking reproductive healthcare needs, 18% were pregnant

• 99% received the intervention on the same day as baseline assessment

• >84% retention rates at follow up points for all groups

• Baseline Primary Substance

▪ 57.2% Nicotine

▪ 11.6% Alcohol

▪ 20.5% Cannabis

▪ 10.7% Other

• Baseline Days/month using Primary Substance: 23.7 +7.9

• Baseline Days/month using Any Substance: 25.7 + 5.9

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Mean Days of Substance Use by

Treatment Group

• E-SBIRT and SBIRT significantly reduced days of primary substance use of Enhanced TAU

• No interaction for pregnancy status, response similar

• At 3 months: 4 (E-TAU) vs. 7 (ESBIRT) vs. 6.3 (SBIRT)

• Differences attenuated at 6 months

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Treatment Seeking

• 121 women (27.6%) used substance use treatment

or self help programs after SBIRT

• Half of the services sought were for smoking

cessation

• Study treatment group had no impact on substance

use treatment seeking afterwards

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Conclusions

• Both e-SBIRT and SBIRT significantly reduced days

of primary substance use compared with enhanced

TAU

▪ Mode of delivery did not appear to affect

outcomes

• No interaction for pregnancy status

• Most effect at 3 months follow up

• No impact on Substance Use Treatment seeking

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Summary

• Substance use in pregnancy is common and may have an adverse impact on pregnancy outcome

• Some examples of innovation

▪ Head to head comparisons of current screening measures

▪ Utilization of technology to extend the reach of approaches such as Brief Interventions

• More research is needed

▪ Best methods to identify prenatal use

▪ Best approaches to modify prenatal use

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Clinical Bonus

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Medication Assisted Treatment

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Alcohol

• FDA approved medications are all Category C

• Disulfiram, Acamprosate, Naltrexone, Extended

release naltrexone

• Psychosocial interventions

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Cigarette Smoking

• Smoking cessation counselling is the mainstay of treatment

• US Preventive Services Task Force (2009, 03-2018 update pending)

▪ Grade A recommendation for counseling

▪ Inadequate evidence to evaluate the safety/efficacy of prenatal pharmacotherapy

• Cochrane Systematic Review (2009)

▪ 72 controlled trials of cessation interventions

▪ 6% of pregnant women will be helped

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Opioid Use Disorders

• Prevent complications of illicit opioid use and

narcotic withdrawal

• Encourage prenatal care and drug treatment

▪ Include prenatal care to reduce the risk of

obstetric complications

• Reduce problematic behaviors

• Avoid risks of “drug culture”

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Opioid Antagonist

• Naloxone

▪ Only to save the woman’s life

• Medically supervised withdrawal is not recommended

▪ High relapse rates

▪ If MAT is not an option

− 2nd trimester, under the supervision of a physician experienced in perinatal addiction, is preferred

− 1st trimester is preferable to continued illicit drug use

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Methadone

• Registered substance abuse treatment program

• Comprehensive package of treatment

▪ Prenatal care

▪ Counselling

▪ Family therapy

▪ Nutritional education

▪ Medical and psychosocial services

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Perinatal Methadone Doses

• Initiated at 10-30 mg per day

• Adjusted throughout pregnancy to avoid withdrawal

symptoms

▪ Third trimester

• Rapid metabolism may require split dosing

• Not all women require dosage adjustments

• Methadone has pharmacokinetic interactions with

many other drugs

• Severity of Neonatal Abstinence Syndrome is not

associated with methadone dosage

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Buprenorphine

• Informed consent about lack of longitudinal data

• Advantages

▪ Lower risk of overdose

▪ Fewer drug interactions

▪ Outpatient basis

▪ Evidence of less severe neonatal abstinence syndrome

• Disadvantages

▪ Hepatic dysfunction

▪ No long-term data about infant and child effects

▪ Clinically important drop out rate

▪ More difficult induction, risk of precipitated withdrawal

▪ Increased risk of diversion

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Buprenorphine

• Single agent product recommended

▪ Same dose for mono-product if switching

• Monitor for diversion

• Inappropriate for patients needing more intensive

structure and supervision

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Buprenorphine vs. Methadone

• Indications for buprenorphine are in flux

▪ Past: refuses/unable to take methadone,

methadone unavailable

▪ Current: prefers to methadone, gives informed

consent, capable of adherence and safe

administration, understands potential of adverse

long-term outcomes

• Transition from methadone to buprenorphine is not

recommended

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Breastfeeding

Recommendations from the American Academy of

Breastfeeding

Clinical Protocol #21

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Breastfeeding

• Challenging balance of risks and benefits

• Evaluation and Management

▪ Prenatal plan to prepare for parenting,

breastfeeding, and SUD treatment

▪ Understanding of the consequences of relapse to

drug or alcohol use during lactation

▪ Teaching about donor milk, formula preparation,

bottle handling, and cleaning

▪ Engagement in treatment pre and post-natally

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Alcohol and Breastfeeding

• 5107 infants and their caregivers

• First assessed in 2004 and then q 2 years

• Children aged 6-7 had lower scores on reasoning

tests if their breastfeeding mothers drank alcohol –

dose response relationship

• Risk factors alcohol while breastfeeding

▪ Older maternal age, increased education, longer

breastfeeding duration

Gibson & Porter, 2018

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PCSS Mentoring Program

▪ PCSS Mentor Program is designed to offer general information to

clinicians about evidence-based clinical practices in prescribing

medications for opioid addiction.

▪ PCSS Mentors are a national network of providers with expertise in

addictions, pain, evidence-based treatment including medication-

assisted treatment.

• 3-tiered approach allows every mentor/mentee relationship to be unique

and catered to the specific needs of the mentee.

• No cost.

For more information visit:

https://pcssNOW.org/mentoring/

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PCSS Discussion Forum

Have a clinical question?

http://pcss.invisionzone.com/register

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American Academy of Family Physicians American Psychiatric Association

American Academy of Neurology American Society of Addiction Medicine

Addiction Technology Transfer Center American Society of Pain Management

Nursing

American Academy of Pain Medicine Association for Medical Education and

Research in Substance Abuse

American Academy of Pediatrics International Nurses Society on Addictions

American College of Emergency Physicians American Psychiatric Nurses Association

American College of Physicians National Association of Community Health

Centers

American Dental Association National Association of Drug Court

Professionals

American Medical Association Southeastern Consortium for Substance

Abuse Training

American Osteopathic Academy of Addiction

Medicine

PCSS is a collaborative effort led by the American Academy of Addiction

Psychiatry (AAAP) in partnership with:

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