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For Women Only

Guideline 4       Opioid Stabilization 14

The following approaches are used to manage the pregnant, opioid-addicted woman. The first approach is methadone maintenance combined with psycho-social counseling. This is a well-documented approach to improve outcomes for both the woman and her fetus.

The second approach is slow medical withdrawal with methadone. The safety of this second approach has not been documented.

Mild withdrawal signs and symptoms include:

*Generalized anxiety                                                                                         *Opioid craving
*Slight aching of muscles, joints, and bones
*Lower back pain

Mild to moderate withdrawal signs and symptoms include :

*Yen sleep (mild insomnia)
* Mydriasis (pupils dilated)
* Lethargy Diaphoresis (increased perspiration)

Moderate withdrawal signs and symptoms include: 

*Chills alternating with flushing and diaphoresis (sweating)
* Nausea and/or stomach cramps
* Rhinorrhea (runny nose)
* Moderate aching of muscles, joints, and bones
* Lower back pain
* Anorexia
* Nausea and/or stomach cramps
*Yawning Lacrimation (tearing)
*Goose flesh (earlier if client is in a cold, drafty room)
*Elevated pulse and blood pressure

Moderate to severe withdrawal signs and symptoms include:

*Tachycardia (pulse over 100 BPM) Increased respiratory rate and depth

Severe withdrawal signs and symptoms include:

*Doubling over with stomach cramps
*Kicking movements
*Elevated temperature (usually low grade, less than 100° F)

Note: Withdrawal signs and symptoms differ in their order of appearance from one individual to another. Some individuals may not exhibit certain withdrawal signs and symptoms. Signs may also include uterine irritability, increased fetal activity, or rarely, hypotension.

Despite its dramatic appearance, the opioid withdrawal syndrome is rarely life-threatening or permanently disabling to an adult. However, there is good evidence that the fetus may be more susceptible to withdrawal symptoms than the mother. In the mother, the initial signs of opioid withdrawal progress to increasingly painful physical symptoms. In addition to these signs, patients show compelling psychological cravings for drugs, as well as drug-seeking behavior.

Methadone substitution is the standard treatment for heroin addiction. Methadone treatment alternatives consist of (1) high-dose blockage; (2) low-dose maintenance; and (3) medical withdrawal.

Medical withdrawal of the opioid-dependent woman is not recommended in pregnancy because of the increased risk to the fetus of intrauterine death.. Methadone maintenance is the treatment of choice. In addition to methadone maintenance, a comprehensive approach is needed that will provide the patient with counseling and other services.

The administration of methadone, combined with any opioid agonist/antagonist such as pentazocine (Talwin), will precipitate withdrawal. 15 Any pregnant woman receiving methadone should be advised against taking opioid agonist/antagonists under all circumstances.

Neonatal abstinence syndrome (NAS) may or may not be related to maternal dose of methadone; NAS may also be related to fetal gestational age and infant weight. However, studies in both pregnant women and other adults have shown that larger doses of methadone result in a decreased use of other drugs.

These effects may be the result of concomitant maternal lifestyle factors rather than the direct result of drug use.

1   Possible Effects on The Pregnancy:

*Intrauterine growth retardation
*Miscarriage Premature rupture of membranes
*Infections Breech presentation (abnormal presentation due to premature delivery) *Preterm labor No effect

2  Possible Effects on The Mother:

*Poor nourishment, with vitamin deficiencies, iron deficiency anemia, and folic acid deficiency anemia
*Medical complications from frequent use of dirty needles (abscesses, ulcers, thrombophlebitis, bacterial endocarditis, hepatitis, and urinary tract infection)
*Sexually transmitted diseases (gonorrhea, chlamydia, syphilis, herpes, and HIV infection) Hypertensive disorder No effect

3 Possible Effects on The Fetus and Newborn Infant:

*Low birth weight
*Neonatal Abstinence Syndrome
*Stillbirth Sudden Infant Death Syndrome
*No effect

The goal of the methadone strategy is to stabilize the patient without producing any indication of opioid abstinence syndrome.

1  Obtain a detailed health history, including alcohol and other drug use and arrangements for prenatal care.

2  Conduct a comprehensive physical examination, including weight, vital signs, and an obstetrical evaluation.

3  Obtain laboratory tests, including:
a) Initial blood workup that includes, but is not limited to:

*Blood Group, Rh factor Determination, and Antibody Screen
*Serological Test for Syphilis
*Hepatitis B and C Screens
*Complete Blood Count with Indices

b) Other initial laboratory tests that include, but are not limited to:

*Cervical cytology smear (Pap smear), unless the provider has results of a test performed within the past 3 months

*Cervical culture for gonorrhea

*Urine screen for urinary tract infections, kidney disease,protein, and glucose

*Chlamydia screen 

4  Obtain purified protein derivative of tuberculin (PPD) test with antigen panel.

5   Obtain urine/blood toxicologies.

6  Provide for HIV antibody counseling and testing.

7  Obtain baseline sonogram if appropriate.

Determine the amount of drug being used and follow the dosing strategy listed below.

1 Evaluate the pattern of drug use, route of administration, and frequency and amount of drug use. Know something about the purity of the street product and the other substances, such as quinine or Valium, with which the product may be cut or diluted.

2 Obtain a detailed history of drug use within the past 24 hours.

3 Give an initial oral methadone dose of 10 to 40 mg. Because it is imperative to reverse any opioid abstinence symptoms as quickly as possible, an additional dose of methadone may be required in the range of 5 to 10 mg if objective signs of withdrawal persist after 3 to 4 hours (time to allow the methadone to reach a peak blood level). This 5- to 10-mg dose can be repeated at 3 to 4 hour intervals until objective signs of withdrawal are no longer present.

4 .Adjust the dosage by 5 to 10 mg daily based on physical signs and symptoms of opioid withdrawal( see table on page 18) and patient comfort.  Even minmal symptoms  in the Mother may indicate stess in the fetus.

5.  After the stabilization dose has been established, keep the patient at this level for several days.

6.  If there is simultaneous dependence on other drugs such as alcohol, cocaine, and sedatives, methadone induction should proceed as outlined in items one through five, while concurrent medical withdrawal procedures are initiated. The other drug withdrawals can be managed as usual against the background of methadone maintenance. Ideally, this is an inpatient procedure.

Administration of a narcotic antagonist to a pregnant-substance abusing woman could result in spontaneous abortion, premature labor and/or stillbirth.

Important Warning:  NARCAN (or any narcotic antagonist) should never be given to a pregnant, substance-using woman except as a last resort to reverse severe narcotic overdose.  Administration of a narcotic antagonist to a pregnant, substance-using woman could result in spontaneous abortion, premature labor, and/or stillbirth.16

Methadone maintenance is strongly encouraged for all pregnant, opioid-dependent women. It provides the following advantages:

»Reduces illegal opioid use as well as use of other drugs.

»Helps to remove the opioid-dependent woman from the drug-seeking environment and eliminates the necessary illegal behavior.

»Prevents fluctuations of the maternal drug level that may occur throughout the day.

»Improves maternal nutrition, increasing the weight of the newborn.

»Improves the woman's ability to participate in prenatal care and other rehabilitation efforts.

»Enhances the woman's ability to prepare for the birth of the infant and begin homemaking.

»Reduces obstetrical complications.

There are no specific guidelines established for methadone dosages for pregnant women. -----  In general, the clinical trend is toward use of an individually determined, most effective dose that is adequate to prevent withdrawal symptoms.

The following guidelines have been used
 for pregnant and
nonpregnant  substance
1 The high-dose methadone blockage is
between 50-150mg per day.
2 The low-dosage methadone maintenance
dosage is less than 60mg per day.
Based on current and emerging research,
The National Institute on Drug Abuse ------
suggests that maintenance doses below
60mg are not effective and hence not
not appropriate..... (17)

Arbitrary low-dose policies for pregnant and nonpregnant patients is often associated with increased drug use as well as reduced program retention. Based on current informed consensus, the most prudent course is to rely on individually determined methadone dosing that is measured by the absence     of subjective and objective abstinence symptoms and the reduction of drug hunger.

An increased methadone dosage may be needed in later stages of pregnancy to prevent withdrawal.   ------  (The greater plasma volume and renal blood flow of pregnancy can contribute to a reduced level of methadone in the blood.   As a result, the woman's maintenance dose may be insufficient to prevent cravings.) Either administer methadone twice a day to give a more even blood level throughout the day or raise the single daily dose.

Medical withdrawal of the pregnant, opioid-dependent woman from methadone is not indicated or recommended. Few women will have the motivation or the psychosocial supports to accomplish and maintain total abstinence.  --------- The goal, therefore, is to achieve the best therapeutic dose possible with which the woman feels comfortable.  The neonatal abstinence syndrome can be treated with minimal complications.

------- Despite the above caution, at times, medical withdrawal may need to be considered due to logistical or geographic barriers. In these cases, the decision to undertake such a program must be a joint decision between the obstetrician, the woman, and her counselor, with the understanding that few women will be appropriate candidates for this approach.

------- The woman should understand that she must prove she is a candidate for medical withdrawal by complying with prenatal and therapy appointments and supplying clean urines.  If at any time the woman is unable to comply with these requirements, no further decrease in dosage of methadone should be ordered.

1   Timing of withdrawal.  There are no research data that suggest withdrawal in one trimester is worse than in others.   Some clinical practitioners indicate concerns regarding methadone withdrawal prior to 14 weeks or after 32 weeks.These concerns are based on the theoretical possibility of an  increased  incidence of  spontaneous  abortion and premature labor.  Other clinicians believe that withdrawal can be performed in all trimesters.

    Patients should be allowed to discontinue withdrawal at any time,  for any reason, without feelings of guilt.  They should then be placed into a methadone maintenance program at a therapeutically sound dose.   Clinicians  need to be particularly aware that a decrease in methadone dosage  could  precipitate  a relapse to drug use.  Patients in continuous treatment who return to illegal drug use should be placed back on methadone.  Methadone is preferable to the use of illegal street drugs.

2    Withdrawal scheduleMedical withdrawal from methadone is usually done in decrements of 2 to 2 1/2 mg every 7 to 10 days. »»» This procedure should only be done in conjunction with an obstetrician who can monitor the effects on the fetus.  »»»»  Intrauterine demise (death of the fetus in utero) has been documented as a complication of medical withdrawal even when done under optimal conditions, such as hospitalization and close fetal monitoring.

Note: At the time of publication, there was no protocol for medical withdrawal from methadone that had been evaluated in an appropriate number of women with suitable scientific and medical rigor.

The long-term effects of the use of clonidine in pregnancy are still unknown.   Although clonidine hydrochloride has been used safely and effectively for rapid medical withdrawal in the management of opioid withdrawal in nonpregnant, opioid-dependent individuals,18   there are no data concerning its safety in pregnancy.   Further research in this area needs to be performed before this technique can be recommended as a standard of care for pregnant women.

I only covered guidelines for women addicted to opioids If you would like information on any of the other medications like alcohol, cocaine, sedative-hynotics, and benzodiazepines then you can order the book below, free of  charge.  Just call (800) 729-6686  or (301) 468-2600.  Just give them the name        of the book below along with  (TIP 2) BKD127.  I  recommend it highly if you
are a pregnant, substance -using woman.   

Reference:  Pregnant, Substance-Using Women (TIP2) BKD127 Guideline 4

19 AUGUST 2007

Marine Biological Laboratory is  currently working to help solve a problem that some 350,000 babies are born with each year: opiate addiction. Richardson, a neuroscientist and second-year postdoctoral fellow in the Pediatrics Department at Johns Hopkins University Hospital, has seen the problem firsthand.

According to Dr Richardson, "Baltimore has a high proportion of opiate-exposed infants. Some of these infants have been exposed to heroin, but a majority of infants are exposed to methadone that the mothers are given to treat the mother's addiction. 

Methadone is good for the mother because it stabilizes her withdrawal symptoms and ensures that she has good prenatal care. But it is a long-acting opiate and thus the infants have withdrawal symptoms after delivery."

Opiate withdrawal in infants, called neonatal abstinence syndrome, is characterized by high-pitched crying, inconsolability, increased muscle tone, tremors, vomiting, diarrhea, and, in severe cases, seizures. "The traditional treatment for reducing these symptoms in babies is a tincture of opium, a diluted form of morphine. But the optimal therapy is to treat them with an agent that's non-addictive," Richardson says.

Basic and clinical research targeting the cellular and molecular mechanisms underlying the development of opiate dependence and withdrawal in the infants are needed. So inside her MBL laboratory, Richardson is using neonatal rat models to study the role of a neurotransmitter called norepinephrine (which is released in high amounts during withdrawal) and its influence on specific brain regions believed to be associated with opiate withdrawal. "The increased release of norepinephrine is a cause of physical withdrawal symptoms," she says.

Richardson is especially interested in the effects of a norepinephrine-blocking drug called clonidine and its possible use as a treatment for opiate (both heroin and methadone) exposed infants. The drug, which is traditionally used for treating high blood pressure, has been shown to relieve withdrawal symptoms in adult humans.

It is currently being used for the treatment of withdrawal symptoms in newborn infants in a randomized double-blind clinical trial by Richardson's mentor, Dr. Estelle B. Gauda, at Johns Hopkins Hospital (the trial is supported by the National Institute on Drug Abuse and the National Institutes of Health).

"The effects of clonidine on withdrawal symptoms are documented in adults but not conclusively in infants," says Richardson, who hopes to shed light on the drug's use as a possible alternative treatment for babies undergoing withdrawal. "The goal is to extrapolate information from animal models, which will ultimately help clinicians decide which therapies are best for neonates who display opiate withdrawal symptoms," she says.

Dr. Richardson is conducting research at the MBL thanks to a fellowship from the Grass Foundation. This program provides a first opportunity for neuroscientists during late stages of predoctoral training or during postdoctoral years to conduct independent research on their own at the MBL each summer.

Gina Hebert
Marine Biological Laboratory

Compiled & Edited By: Deborah Shrira-Publisher   Updated:  April 2008