AATOD Conference Recap: Field Has Funding, Now Needs Infrastructure
	An Interview With Dr. McCance-Katz On Importance of Medications and Psychosocial Treatment
	Department of Justice Tells State Attorneys General: ADA Protects People On MAT
	With “Open-Access,” Methadone Treatment Can Increase Patient Census and Eliminate Waiting Lists: Research
	MAT During Incarceration Reduces Overdose Deaths
	MOTHER Study Babies Thrive at Three Years; AT Forum Talks With Lead Authors
	When Mom Is Better Than Morphine: Shorten Stay and Decrease Costs For Babies With Methadone-Related NAS
	Events

Categories: Newsletter, TOC

By Alison Knopf

There were more than 2,000 attendees at the 2018 conference of the American Association for the Treatment of Opioid Dependence (AATOD), held at the Marriott Marquis in New York City in March.

The five-day meeting was full of presentations, workshops, and formal and informal gatherings, where leaders and staffers in the field of treatment of opioid use disorders exchanged knowledge and experience.

Open Board Meeting: Concerns About STR Funding

The open board meeting, which took place March 10, was an important time to share concerns about funding and regulatory matters with federal agencies. Board members had many questions for the Substance Abuse and Mental Health Services Administration (SAMHSA). The questions were related to the State Targeted Response (STR) to the Opioid Crisis grant program, which added $1 billion to the opioid treatment landscape via state funds.

SAMHSA’s Onaje Salim, EdD, conducted his agency’s presentation at the open board meeting. He was confronted by questions about why so much of the STR funding was going to pay for buprenorphine, naloxone kits, and prevention messages, but relatively few contracts with opioid treatment programs (OTPs) were being funded, to expand treatment in a more comprehensive way.

Dr. Salim was very sympathetic to the concerns of the AATOD board members. Formerly the administrator of an OTP in Atlanta, Dr. Salim was the first Georgia delegate to the AATOD board of directors. Later he became the Single State Authority for Georgia, before going on to SAMHSA.

But concern persisted at the board meeting: Would the STR funding be used for the same projects in year 2 as in year 1? And how would SAMHSA be able to guarantee that the funds were being put to good use? “How do you give the same level of funding if you don’t understand if it worked the first year?” as AATOD president Mark Parrino, MPA, put it.

OTPs’ Missed Opportunity

The time for OTPs to have made their case, however, was back in December of 2016 when the STR grants were announced. States prepared their applications then, and although a new federal administration was coming in, the funding process was underway. OTPs needed to go to the states at that time to present their arguments.

“I did say to my board members and provider colleagues that if you guys want to get these funds, you have to plant yourselves in the state offices,” Mr. Parrino told AT Forum.

On the other hand, states also have an obligation to use federal funds judiciously and to reach out to the appropriate partners, including OTPs, said Mr. Parrino. If states are not including OTPs as part of their treatment expansion strategies, then that needs to be explained as well. While a number of federal and state agencies are moving quickly to increase access to treatment, it is also important to be accountable in how these funds are spent.

And it is up to SAMHSA to hold states accountable for their use of STR funds, said Mr. Parrino. “SAMHSA should be holding the states’ feet to the fire. This is a straightforward issue.”

Buprenorphine Data 2000 Prescribers—Where Are Comprehensive Services?

The challenge from DATA 2000 practices—buprenorphine prescribers who do not necessarily provide comprehensive services—is felt keenly by the OTP community.

SAMHSA is invested in quality treatment services. Still, how this need for quality is implemented in DATA 2000 practices “is going to be a mystery,” said Mr. Parrino. While Elinore McCance-Katz, MD, PhD, who heads SAMHSA, says she wants coordinated services, how does this apply to DATA 2000 practices, which only have to prescribe buprenorphine and not provide any other care?

It is also true that there are many DATA 2000 practices that are offering excellent care. There should be some consideration in identifying treatment providers who do provide excellent treatment utilizing evidence-base practices, said Mr. Parrino. This issue will take on greater importance as insurance companies use a number of strategies to identify providers, which should be part of their network.

AATOD supports all three medications approved to treat opioid use disorder, but, like Dr. McCance-Katz, it endorses treatment that is comprehensive, not just restricted to prescribing and dispensing medication.

Mobile Vans Haven’t Yet Hit the Road

The Drug Enforcement Administration’s Jim Arnold, section chief of the liaison and policy section, explained to the AATOD board that mobile vans are not a reality yet because of President Trump’s executive order calling for eliminating two regulations for every new one. He said that the DEA was trying, however, and had sent it to the general counsel, but got it back with 70 requested modifications.

“So it’s slowed down,” said Mr. Parrino. “It’s not that anyone is saying ‘We don’t want to do this,’ because the DEA does want to do it,” he said.

The holdup is a problem in the way states use the STR money, as well. For example,

Molly Carney, executive director of Evergreen Treatment Services, wanted to use Washington’s STR grant for 2017 to get two new vans. She couldn’t, because of the DEA.

Awards Banquet: Former New Jersey Governor Attacks Stigma

If there were any questions as to why Chris Christie was chosen for the Friend of the Field award, the passionate acceptance speech by the former governor of New Jersey answered them. He attacked stigma directly, as the main reason for access problems for patients seeking methadone and buprenorphine treatment.

The Nyswander/Dole “Marie” awards at the banquet, which was sponsored by Mallinckrodt Pharmaceuticals, went to:

• Gloria Baciewicz, MD (a psychiatrist based in Rochester, New York, who broke ground 25 years ago in getting upstate communities to start to accept methadone);
• Hope Bolger, RPh (among many other credits, she has been the State Opioid Treatment Authority for Virginia, where the number of opioid treatment programs tripled during her tenure);
• Jonas Coatsworth, MA, LPC, CAC-II (a leader in methadone and recovery in South Carolina);
• Gabriele Fischer, MD (an Austria-based psychiatrist who has promoted methadone maintenance through the World Health Organization and the United Nations Office on Drugs and Crime);
• Kathleen Maurer, MD (the medical director of Connecticut’s Department of Correction, where she instituted methadone maintenance treatment in prisons);
• Stacey Pearce, CAS (treatment program director and methadone treatment advocate in Georgia); and
• Vickie L. Walters, LCSW-C (a treatment advocate based in Maryland).

The Richard Lane/Robert Holden Patient Advocacy Award went to Paul Bowman, CMA, Boston National Alliance for Medication Assisted Recovery chapter director, patient advisor to Habit OPCO, consultant to residency programs, and more.

Connectivity and Importance of Staff

The conference itself was a chance for OTP staff from around the country to get together. Looking over the history of the conference programs, it’s easy to see trends in the field. Mr. Parrino believes the conferences promote “connectivity,” so that stakeholders and conference attendees can understand how their work is related to regulatory changes and other moves on the state and federal levels.

Now that the field has the money—from the STR grant program, with new funding expected—the question is, do OTPs have the infrastructure? Programs are opening, and in some states, the growth is dramatic. “In Ohio, it’s like the gold rush,” said Mr. Parrino. But, as he said at the open board meeting, as OTPs expand, they must be sure that they have the workforce to do this properly, and that they have the money to support the workforce.

“There’s a connection between retaining staff and retaining patients,” said Mr. Parrino. Success in treatment is driven by the characteristics of the treatment program, not the characteristics of the patient, as the John Ball study showed (see citation, below).

Currently, there are about 1,600 OTPs in the United States. By October of 2019, when the next AATOD conference takes place in Orlando, that number will be 1,800, Mr. Parrino told AT Forum. “I’d like it to be 2,000,” he said. “But remember, the number must be reflected in the ability to open and staff the programs.”

Reference

Ball JC, Lange WR, Myers CP, Friedman SR. Reducing the risk of AIDS through methadone maintenance treatment. J Health Soc Behav. 1988;Sep;29(3):214-226.

Categories: Addiction, Buprenorphine, Events, Medication-Assisted Treatment (MAT), Methadone, Newsletter, OBOT, Opioid Abuse/Addiction, Opioid Treatment Programs (OTPs), Opioids, Overdose, Prescription Drugs
Tags: AATOD, Addiction, Buprenorphine, naloxone, Overdose, Prescription Opioids, SAMHSA, Stigma, Substance Abuse Treatment

By Alison Knopf

Elinore F. McCance-Katz, MD, PhD, assistant secretary for mental health and substance use at the Department of Health and Human Services, and head of the Substance Abuse and Mental Health Services Administration (SAMHSA), is passionate about the importance of medication-assisted treatment (MAT) for opioid use disorders (OUDs). And she considers medications and comprehensive wraparound services as being essential.

The three medications approved to treat OUDs are methadone, buprenorphine, and naltrexone. “Science clearly shows that these three work, if you stay on them,” said Dr. McCance-Katz, emphasizing the “if.” Abstinence-based treatment doesn’t work for most people, she said, although naltrexone can be viewed as abstinence treatment in terms of opioids, and it does require complete withdrawal from opioids first.

Only opioid treatment programs (OTPs) are able to offer all three medications, she noted.

OTPs also provide the added support that is crucial to recovery, she said. She is concerned that office-based opioid treatment (OBOT), if not regulated, would lead to pill mills, and these could damage and jeopardize the integrity and survival of treatment itself. Currently, OTPs are the most highly regulated treatment settings for OUDs, followed by the relatively loosely regulated OBOT providers with DATA waivers.

TIP 63: Medications for Opioid Use Disorder (Updating TIPs 40 and 43)

In February, SAMHSA released Treatment Improvement Protocol (TIP) 63, Medications for Opioid Use Disorder. The new publication updates TIPs 40 and 43. Dr. McCance-Katz oversaw the development of the new TIP.

SAMHSA’s TIP series provides best practices in the behavioral health field. Each TIP’s consensus panel includes researchers, service providers, program administrators, and patient advocates, with content assessed by field reviewers. The new TIP provides an overview and detailed information on the use of methadone, buprenorphine, and naltrexone.

The new TIP does not cover some of the newer versions of buprenorphine, such as injectables. “I was hoping to do that before the TIP came out, but we were under a statutory deadline,” said Dr. McCance-Katz. “The package inserts hadn’t been finalized. We will have to do an addendum; the Food and Drug Administration is considering some other formulations as well.”

Changing From Methadone to Buprenorphine: Not an Easy Switch

We asked Dr. McCance-Katz how to respond to requests from patients who want to switch from methadone to buprenorphine—not because of any issue with their medication, but because of the less onerous requirements for clinic visits. Patients can get take-homes and prescriptions sooner with buprenorphine than with methadone.

“It’s true that if you’re on buprenorphine you can get a prescription—it’s a Schedule III medication, not a Schedule II, like methadone. But people need to be seen more regularly,” she said, “especially early in treatment.” She admitted that requiring patients to go to the OTP every day for dosing—especially when the clinic is far away, or weather is bad—can be a deterrent. “I know that many people have a hard time adhering to the requirements of methadone programs, particularly in terms of the number of times they must go to the clinic.”

But if patients have been stable on methadone, and are doing well in their lives, it is not a good idea to switch, she said. “While buprenorphine is more convenient, we can’t be sure that it will work as well for patients doing well on methadone.”

Switching is very difficult for methadone patients, who would have to get down to 30 milligrams of methadone or less before starting buprenorphine, she said. “And that’s not easy to do. It introduces a lot of unknowns in terms of how the person is going to do; I’ve worked with people trying to do it.”

Another issue is that the standard dose of buprenorphine is 16 milligrams, with the maximum dose 24 (not 32, as TIP 40 said; she changed this in TIP 63). “Most people stabilize at 16 milligrams of buprenorphine, but this may not be a high enough dose for someone maintained on a higher dose of methadone. So, after all the work of tapering down to 30 milligrams of methadone, and then switching, the patient may still be craving and uncomfortable. Was it worth it?”

But it’s still a conversation that the doctor can have with the patient. “If the patient really wants to taper down, I would talk with them, we would have many discussions,” she said.

States May Insist on Stricter Take-Home Policies

While SSAs are familiar with the benefits of methadone, the governors they work for, as well as the state legislature, may have a different philosophy. And that—not the SSAs and the SOTAs they work for—has been the main sticking point in states that refuse to liberalize take-home policies.

Asked whether SAMHSA can do anything about states that have stricter take-home limitations on methadone than the federal guidelines, Dr. McCance-Katz said that it could not.

“States can have stricter guidelines; ” she said. “We work with states, we meet with the SSAs [Single State Authorities] in states, we make it clear that we believe that people who have been on methadone and are stable should have less frequent visits,” she said. “The states may or may not listen to us on that.”

For more information on TIP 63, including the full text, go to: https://store.samhsa.gov/product/TIP-63-Medications-for-Opioid-Use-Disorders-Executive-Summary/SMA18-5063EXSUMM

Categories: Addiction, Buprenorphine, Medication-Assisted Treatment (MAT), Methadone, Newsletter, OBOT, Opioid Abuse/Addiction, Opioid Treatment Programs (OTPs), Opioids
Tags: Buprenorphine, Methadone Treatment, naltrexone, Opioid Treatment Programs, SAMHSA, Substance Abuse Treatment

By Alison Knopf

For the first time ever, the Department of Justice (DOJ) has sent a letter to a state attorney general, stating that judges generally may not order people off addiction medications such as methadone or buprenorphine to get custody of their children—or for any other reasons.

The Legal Action Center publicized the letter, which was issued in October 2017 by the Acting U.S. Attorney for the Southern District of New York to the state’s attorney general, explaining that prohibiting the use of medication-assisted treatment (MAT) may be a violation of the Americans with Disabilities Act (ADA).

Examples of illegal discrimination in the letter include “. . .  a court generally could not deny a parent visitation of her child by reason of the parent’s . . .  current use of MAT.  Nor could a court impose a blanket rule requiring parents to stop participating in MAT in order to gain custody of their children.”

A Game-Changer Initiative

In December, Acting Assistant Attorney General John Gore of the Civil Rights Division announced that the DOJ will work with United States attorneys around the country to eliminate discriminatory barriers to treatment for people with opioid and other substance use disorders. This initiative, according to the Legal Action Center, is a “game changer” in reversing discrimination that has been a barrier to MAT, even in the middle of an opioid epidemic.

We talked with Sally Friedman, legal director for the Legal Action Center, about the new initiative.

The DOJ letter was written in reference to a judge in Sullivan County, New York, who had told a methadone patient and a buprenorphine patient that they had to stop treatment. The condition was imposed in one case to regain custody of her child; in the other to successfully complete probation (that woman also had a child, and was hoping ultimately to get custody). The Legal Action Center had heard that the judge routinely prohibited MAT.

Ms. Friedman brought the matter to the attention of Preet Bharara when he was still U.S. Attorney for the Southern District of New York. Mr. Bharara was speaking at an opioid forum at a law school. “We explained to him why we thought this violated the ADA, and shared our report on this topic,” Ms. Friedman told AT Forum. This led, ultimately, to the letter by the DOJ. Ms. Friedman also brought many cases to the attention of DOJ’s Washington D.C. office, which set in motion steps culminating in the DOJ Opioid Initiative.

Attorneys Need to Know About ADA Protections

It’s urgent for lawyers to raise ADA objections when their clients are being denied access to MAT, said Ms. Friedman. “Sadly, many people don’t know about these protections,” she said of the ADA, MAT, and the courts. “Individuals who receive MAT don’t know, their treatment providers don’t know. Nor do public defense lawyers, or prosecutors. As for judges, many don’t even think of addiction as a disability. Individuals prohibited access to MAT should file complaints with the DOJ.  So should their treating providers,” said Ms. Friedman.

The Legal Action Center has represented people denied access to MAT and provided backup support for other lawyers.  But until this DOJ letter, there was little legal authority directly addressing courts that prohibit MAT. “For years we’ve often felt that we have been bashing our heads against a brick wall,” Ms. Friedman said. “Now the Justice Department has clearly stated that courts that prohibit MAT can violate the ADA.  They are ready move on the issue, but they need complaints in order to act.”

The initiative is not only about people involved in the criminal justice or child welfare systems, Ms. Friedman commented. It’s also about zoning and any other discriminatory actions related to treatment—all of which can violate the ADA. “I do see the wind shifting on this issue. It’s been a long, long battle. I’ve trained a lot of court personnel, but I know these problems still go on. However, finally, there’s a gradual swing in the other direction.”

What OTPs Can Do

Here’s what OTPs should do if one of their patients is told by a court to stop taking medication.

1. File a complaint with the DOJ and advise their patients to file a complaint, using the online complaint form at https://www.ada.gov/filing_complaint.htm. “The more they hear from people, the more likely they are to do something,” said Ms. Friedman.
2. Write a convincing letter about why MAT is clinically appropriate for your patient and why discontinuing MAT is harmful. “The courts need detailed, objective evidence on why the use of MAT is appropriate,” said Ms. Friedman. A sample letter is available on the Legal Action Center’s website at www.lac.org/MAT-advocacy.
3. Fill out an online complaint form on the Legal Action Center’s website at www.lac.org/MAT-advocacy so that the Center can track these complaints and offer back-up assistance.
4. Use the tools in Legal Action Center’s MAT Advocacy Toolkit, including Advocating for Your Recovery. All are available at lac.org/MAT-advocacy.
5. Connect with local regulators, elected officials, and advocates and offer to educate court officials about MAT and discuss their concerns.

For the DOJ letter, go to https://lac.org/wp-content/uploads/2018/02/DOJ-SDNY-ltr-to-OCA-10.3.17.pdf

Categories: Addiction, Buprenorphine, Medication-Assisted Treatment (MAT), Medication-Assisted Treatment (MAT), Methadone, Newsletter, Opioid Abuse/Addiction, Opioids, Patient Advocacy
Tags: Buprenorphine, Criminal Justice, Medication-Assisted Treatment, Methadone Treatment, Substance Abuse Treatment

By Alison Knopf

In a study of “open access” treatment with methadone maintenance, reducing barriers to treatment led to a tripling of the patient census and elimination of the waiting list, with all patients getting same-day treatment. There were no ill effects on the program’s financial stability. Facilities conducting the study include the APT Foundation, a not-for-profit opioid treatment program (OTP) clinic in New Haven, Connecticut; the University of Wisconsin/Madison; and Yale University School of Medicine.

The study was conducted using records of APT patients entering treatment between July 2006 and June 2015.

Phase I

For the first phase, APT used a rapid-cycle change model developed by the Network for the Improvement of Addiction Treatment (NIATx). In this model, a NIATx coach did a “walk-through” of the clinic with clinic staff, looking for barriers to treatment at the intake procedure. The change team identified multiple barriers involving waiting time and access, and developed a plan for eliminating those barriers. They made these changes:

• Modified tuberculosis testing procedures
• Changed verification of addiction procedures
• Discontinued the back-balance payment requirement and the upfront administrative, physical examination, and tapering fees
• Changed the admission fee structure

Phase 2

Phase 2 followed shortly thereafter, and consisted of looking for barriers to access, to retention, and to increases in capacity. Among the changes being made concurrently with Phase 2 were walk-in evaluations, same-day treatment initiation, and the initiation of “drop-in” groups.

Long waiting time, patient financial fees, and methadone underdosing were identified as barriers to treatment access and retention.

Study Design

For this study, the researchers looked at the primary outcomes of the changes made: census (number of patients enrolled in treatment), waiting time (number of days between face-to-face appointment and first methadone dose), retention (the number of patients in treatment longer than 90 days), illicit opioid use (based on drug testing), patient mortality, and program financial stability (net income and state block grants as proportions of total revenue).

Results

Between 2006 and 2015:

• Census increased 183%, from 1,431 to 4,051 patients
• Waiting time decreased from 21.3 days to 0.3 (same day)

Financial stability is a complex picture. State block grant dollars fell 14% from 2006 to 2015. Put another way, state block grant dollars fell as a proportion of revenue from 49% to 24%. During that time, net operating margin rose from 2% to 10%, and total revenue increased. The rise in revenue resulted from greater patient volume, increased efficiency (such as streamlining intake procedures), and expansion of coverage for methadone maintenance treatment through the Affordable Care Act.

Interim methadone treatment is an option, but not one that most OTPs like, because ultimately it means discharging patients. The open access model shows that it is possible to treat more patients, and to start them on treatment the first day they show up for care.

Some changes were simple. For example, replacing the individual counseling sessions with “drop-in” groups was popular among patients. Likewise, making patients “pay up” before getting treatment was an easy barrier to eliminate.

Findings and Recommendations

“Findings here provide a framework for scaling up MAT both in the United States and internationally,” the authors wrote. OTPs traditionally operate with the idea that the number of patients has to be fixed. When demand for treatment rises, patients are turned away or put on waiting lists. It’s common for patients to have to wait a month for treatment in the United States.

With lethal fentanyl on the streets, it’s vital to get people into treatment when they ask for it. It’s also humane.

(Note: Kimberly Johnson, PhD, former director of the Center for Substance Abuse Treatment at the Substance Abuse and Mental Health Services Administration, had previously run NIATx. It’s telling that one of her favorite stories from her time at CSAT occurred when she visited a methadone clinic in Africa, and found that the clinic treated everyone who wanted it. No barriers existed.)

Madden LM, Farnum SO, Eggert KF, et al: An investigation of an open-access model for scaling up methadone maintenance treatment [Epub ahead of print February 17, 2018]. Addiction. doi: 10.1111/add.14198.

Categories: Addiction, Medication-Assisted Treatment (MAT), Newsletter, Opioid Abuse/Addiction, Opioid Treatment Programs (OTPs), Opioids
Tags: Addiction, Methadone Treatment, Opioid Treatment Programs, Substance Abuse Treatment

By Alison Knopf

Medication-assisted treatment (MAT) for opioid use disorder provided to incarcerated individuals sharply reduced overdose deaths after the inmates were released, researchers in Rhode Island have found. The reduction was so large that it contributed to a greater than 12% overall population-level decline in overdose fatalities in the state, according to the study, which is published as a Research Letter in the April issue of JAMA Psychiatry.

The results are consistent with other studies of MAT provided during incarceration. However, the results are especially significant considering that they “occurred in the face of a devastating, illicit, fentanyl-driven overdose epidemic,” the researchers, who were headed by senior author Josiah Rich, MD, wrote.

In July 2016, the Rhode Island Department of Corrections (RIDOC), a unified prison/jail, launched a new screening and protocoled treatment with MAT (including methadone, buprenorphine, or naltrexone) along with an opioid treatment program (OTP), which agreed to provide MAT after release. All sites were fully operational, providing treatment, by January 2017. Individuals who went to RIDOC already on MAT were maintained on their medications without tapering or discontinuation.

Study

For the retrospective cohort study, researchers used data from the Rhode Island Office of State Medical Examiners for all unintentional deaths from overdose, and linked it to data from RIDOC. They compared data from January-June 2016 with data from January-June 2017. Monthly receipt of MAT, counts of naloxone provided to inmates after release, and aggregated data of inmates released were reported.

Results

There were 179 overdose deaths in Rhode Island from January 1, 2016, to June 30, 2016, compared with 157 overdose deaths during the same period in 2017, a reduction of 12.3%. Most deaths were fentanyl-related.

“Identification and treatment of opioid use disorder in criminal justice settings with a linkage to medication and supportive care after release from incarceration is a promising strategy to rapidly address the high rates of overdose and opioid use disorder in the community,” the researchers concluded.

In an interview with AT Forum, Dr. Rich explained that 100 incarcerated individuals a month are    leaving the system on one of the medications—more than 1,000 people, so far. “About a dozen” take naltrexone; the rest are evenly divided between methadone and buprenorphine treatment.

Reference

Green TC, Clarke J, Brinkley-Rubinstein L, et al. Postincarceration fatal overdoses after implementing medications for addiction treatment in a statewide correctional system [Epub ahead of print February 14, 2018]. JAMA Psychiatry. Research Letter. 2018;75(4):405-407. doi: 10.1001/jamapsychiatry.2017.4614.

Categories: Addiction, Buprenorphine, Drug Courts & Criminal Justice, Medication-Assisted Treatment (MAT), Methadone, Newsletter, Opioid Treatment Programs (OTPs), Opioids, Overdose
Tags: Buprenorphine, Criminal Justice, Methadone Treatment, naltrexone, opioids, Overdose

 By Barbara Goodheart, ELS

It’s long been known that medication-assisted treatment (MAT), with adequate doses of methadone or buprenorphine, can stabilize women during pregnancy and prevent relapse. But a key question has confronted the addiction-treatment field for years: If mothers-to-be undergo MAT, will it affect their unborn babies?

The MOTHER Study, an ongoing investigation that began in May 2005, was designed to answer that question and related issues. Papers published in 2010 and 2012 specified the protocol and procedures for subsequent MOTHER studies (see References, below).

The recently completed segment of the study, summarized below, compared outcomes in babies exposed before birth to methadone or buprenorphine, and to infants who required treatment for neonatal abstinence syndrome (NAS), to those who did not require treatment, from birth to age three. Drug and Alcohol Dependence posted the results on February 1.

Key Findings:

Children exposed to methadone or buprenorphine before birth followed a three-year path of normal physical and mental development.

Children who required treatment for NAS did not differ in developmental outcome from children who did not require treatment.

Details of the MOTHER Study

AT Forum interviewed the lead author of the current study, Karol Kaltenbach, PhD, and a co-author, Hendrée Jones, PhD, the lead author of the MOTHER randomized controlled trial. Both have been at the forefront of the MOTHER study since its beginning.

Below is a summary of the current study, and highlights of a discussion with the study’s authors.

Summary of Results

The research team found that the severity of NAS did not adversely impact early childhood growth and development. Measured at three years, development was normal in the broad areas of physical growth, cognition, and language. (See a related article in this issue, “When Mom is Better Than Morphine . . . ” discussing optimal treatment of NAS.)

Mothers Had “Minimal to No” Substance Use

The published article noted that the MOTHER sample was unique in that there was minimal or no prenatal exposure to alcohol or other substances, except tobacco.

We commented, “Such good control of substance exposure wasn’t typical of other studies, was it?”

It wasn’t. Planning was the key, along with the strict inclusion and exclusion criteria followed in the MOTHER study. “We didn’t enroll anyone who misused alcohol or benzodiazepines,” Dr. Kaltenbach said. She explained that an average methadone dose back in the 1980s was 42 mg—”but that amount was based on flawed studies,” and often amounted to underdosing—so, for relief, patients tended to turn to other opioids, barbiturates, and benzodiazepines. “But no one today uses average methadone doses that low.”

To help verify their patients lack of exposure to other drugs, the team collected urine samples three times a week and analyzed them for evidence of alcohol or other drugs.

Motivation helped, as well. “We had an extremely effective voucher system,” Dr. Kaltenbach said. “Mothers who entered the study early, and had urine test results that consistently showed no illicit drug use, could earn vouchers to use for baby supplies, household items, rental deposits, etc.”

Other Studies, Other Findings

If the MOTHER study babies have done so well, physically and mentally, why have other studies reported or suggested problems? These include vision, motor, and behavioral difficulties; genetic variations; sleep disturbances; ear infections; and cognitive problems.

We asked for specifics.

The authors explained that the variability in results and in the interpretation of results may be due to the design and methods of other studies. If important factors of the prenatal and postnatal environment are not measured or accounted for, different conclusions are drawn.

Detoxification

 When asked if it’s safe to withdraw methadone or buprenorphine during pregnancy, Dr. Kaltenbach answered, “The real question is not if it’s safe, but whether you should do it. If the mother is misusing drugs and goes into withdrawal, the fetus will go through withdrawal, too.”

Dr. Jones agreed. “Detoxification doesn’t work well for the vast majority of women who aren’t pregnant—so why would it work any better for pregnant women?

“The relapse rate is incredibly high, 85%, one month after detoxification. If the goal of detoxification during pregnancy is to avoid NAS—the collective published data show that some proportion of babies continue to have it. Thus, detoxification does not avoid NAS.”

And why is withdrawal such a controversial issue?

Dr. Kaltenbach explained that some people think that withdrawing the mother from all drugs will mean the baby will not have NAS. “But now, the mother is at risk of relapse.

“NAS can be treated. And we have evidence that it doesn’t cause long-term deficits. But if the mother returns to the substance she’d been taking, and takes the same dose, she could have a fatal reaction.”

#  #  #

After discussing the main topics of the three-year study, the authors delved into something close to their hearts—the importance of seeing the mothers as people, rather than subjects who misuse drugs, or participants in a study. They commented briefly on the lives the study mothers lead, and the difficulties they face.

Fears

“Even with a plan of safe care, many women fear that Child Protective Services will automatically remove their children,” Dr. Jones said. “But Child Protective Services is an ally; they don’t want to take the baby. It’s expensive, and lots of paperwork is involved. Their aim is to remove children only if it’s really unsafe for them to be living as they are.”

Judgments

Dr. Kaltenbach offered an example of judgmental framework. Factors affecting how severe opioid withdrawal will be include the mother’s alcohol use, benzodiazephine use, and cigarette smoking. None of the three by itself will cause NAS severe enough to require treatment. But, when combined with opioid discontinuation, any one of them could make the withdrawal process take more time or be more severe.

The problem, she said, comes when the mother’s use of these substances “is interpreted in a judgmental framework—a mother uses illegal drugs, so we have to protect her baby from her. Instead, we should focus on what we can do to improve the mother’s condition, so she can have a healthy baby, and can be a healthy mother for her baby.”

The Mother-Infant Dyad

“Too often, people want to separate the mother and infant dyad,” Dr. Kaltenbach said. “They focus on . . . well, the mother uses illicit drugs, so . . . she’s a bad person; we must save the baby.”

Instead, she said, we need to provide for the mother and the infant together. “We need a healthy mother in order to have a healthy infant.” Providing the mother with comprehensive treatment means she will receive prenatal care and addiction treatment, she said, and babies usually go to term.

“It’s a much different outcome if the mother is on the street, using an illicit substance. You can have NAS in both situations, because opioids cross the placenta. But the rest of the environment is very different. One is very supportive; the other is very dangerous.”

The Whole-Person View

“There seems to be a hyper-focus on looking for the negative long-term developmental effects among children exposed to opiates before birth,” Dr. Jones said. The approach she and Dr. Kaltenbach prefer is the that of the “whole person.”

“We need to be looking at factors of poverty, trauma, poor nutrition, dehydration, and chronic severe, toxic stress in our women. And looking at social determinates of health, in terms of our ability to predict risk and resilience for the children. We need to take a more holistic approach.”

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References

Kaltenbach K, O’Grady KE, Heil SH, et al. Prenatal exposure to methadone or buprenorphine: Early childhood developmental outcomes. Drug Alc Depend. 2018;185:40-49. doi:
https://doi.org/10.1016/j.drugalcdep.2017.11.030.

Jones EJ, Kaltenbach K, Heil SH. Neonatal Abstinence Syndrome After Methadone or Buprenorphine Exposure. NEJM. 2010; December 9;363(24):2320-31. doi: 10.1056/NEJMoa1005359.doi: 10.1056/NEJMoa1005359.

Jones EJ, Fischer G, Heil SH, et al. Maternal opioid treatment: Human experimental research (MOTHER) – Approach, issues, and lessons learned. Addiction. 2012;November;107(0.1):28-35. doi: 10.1111/j.1360-0443.2012.04036.x.

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Categories: Addiction, Medication-Assisted Treatment (MAT), Newsletter, Opioid Abuse/Addiction, Opioid Treatment Programs (OTPs), Opioids
Tags: Pregnancy

By Alison Knopf

When Loretta Finnegan, MD, a champion of medication-assisted treatment with methadone, developed her famous scoring system for newborns—more than 40 years ago—mother and infant dyad designed to determine the severity of neonatal abstinence syndrome (NAS) due to opioid withdrawal, it was an important step in ensuring that these babies were treated—usually with morphine. Using the Finnegan Neonatal Abstinence Scoring System (FNASS), the hospital assigns a numerical score to 21 subjective clinical signs, and treats the baby accordingly.

However, there is insufficient evidence that FNASS scores should be used for starting or changing pharmacologic treatment for NAS. In addition, obtaining a FNASS score is traumatic: the baby must be disturbed and unswaddled, which only increases the likelihood of high scores for tremors, tone, and crying, researchers wrote last year in Pediatrics.

NICU Not the Best Place

Treating infants with NAS has traditionally been done by putting them in the neonatal intensive care unit (NICU) and gradually decreasing their doses of morphine. Most institutions do reduce length of stay by using a weaning protocol for morphine with the FNASS, but this must be done in a NICU.

There is no evidence that NAS requires a stay in the NICU, the researchers wrote. In fact, the NICU conflicts with rooming-in, which itself has been shown to be an effective intervention with NAS.

“We discontinued the practice of directly admitting infants at risk for NAS to the NICU after birth in an effort to keep the mother-infant dyad intact,” the researchers wrote.

Furthermore, it is the morphine administration that lengthens the stay, so the hospital wanted to see if morphine was really necessary. In most cases, it wasn’t.

The researchers “set out to change the paradigm of how we approached the management of infants with NAS,” specifically by using nonpharmacologic interventions.

Empowering Patients

Researchers found that keeping these babies out of the NICU and giving them nonpharmacologic treatment—in addition to empowering parents—saves money and time in the hospital. It also means that these babies aren’t labeled. And finally, it sets up the mother and baby for a beneficial interaction that reinforces positive parenting skills.

For the study, researchers at Yale New Haven Children’s Hospital implemented “plan-do-study-act” cycles in response to a 74% increase (from 2003 to 2009) in the number of infants who had been exposed to methadone in utero. Too many of them were staying in the hospital for too long, and the researchers had as a goal reducing the average length of stay by 50%. They far exceeded that goal.

The study, which started in 2010, included 287 methadone-exposed infants. There were no readmissions for treating NAS, and no adverse events.

Results

• Percentage of infants treated with morphine fell from 98% to 14%
• Average length of stay dropped from 22.4 to 5.9 days
• Average costs decreased from $44,824 to $10,289

The researchers developed and implemented eight interventions over a 5-year period:

• Standardized nonpharmacologic care
• Counseled parents prenatally
• Transferred the baby from well-baby nursery to the inpatient unit (with the mother)
• Developed a novel approach to assessment
• Gave morphine as needed, based on infants’ crying, feeding, and sleeping habits
• Empowered parents to care for their babies
• Spread the concepts—and the idea of change—throughout the NICU

The key to nonpharmacologic intervention was the parent—typically, the mother. Parents were strongly encouraged to room-in, to feed their infants on demand, and to take care of the child if he or she cried. Breast-feeding was encouraged, as long as there was no illicit drug use, and the mother was HIV-negative.

The environment included dimmed lights and reduced noise—the opposite of a NICU.

Staff training was required, with the nurses learning to view the nonpharmacologic intervention the same as a medication: “When increased intervention was warranted, the approach was to increase the involvement of the parents before using pharmacologic treatment.”

The parents were empowered by the message that they were the most important treatment for the child: the comfort measures should be performed by the mother or father.

Three Parameters

While the FNASS scores were still used in the well-baby nursery and the NICU, the researchers developed their own assessment for babies on the inpatient unit rooming in with the mother. They used three parameters: the infant’s ability to eat, to sleep, and to be consoled.

If it took 10 minutes or more to console a crying baby, if a baby couldn’t sleep for more than an hour, or couldn’t feed, nonpharmacologic measures were increased. Finally, if these didn’t work, morphine was given, as needed. This differs from the rapid morphine scheduled weans done using FNASS.

“Our approach encouraged providers to focus on a small number of clinically relevant factors to assess the need for treatment with morphine,” they wrote. “Ideally, all infants should feed well, sleep well, and be easily consoled. We determined that if infants with NAS met these goals, then treatment was successful irrespective of the FNASS score.”

Reference

Grossman MR, Berkwitt AK, Osborn RR, et al. An initiative to improve the quality of care of infants with neonatal abstinence syndrome [Epub ahead of print May 18, 2017]. Pediatrics. 2017;Jun;139(6). doi:10.1542/peds.2016-3360.

 

Categories: Medication-Assisted Treatment (MAT), Medication-Assisted Treatment (MAT), Newsletter, Opioid Treatment Programs (OTPs)
Tags: Pregnancy

National Association of Addiction Treatment Providers (NAATP) 40th Annual Conference
May 20-22, 2018
Denver, Colorado
Contact: https://www.naatp.org/

Society for Clinical Trials (SCT) Annual Meeting
May 20-23, 2018
Portland, Oregon
Contact: http://www.sctweb.org/

National Association of State Alcohol and Drug Abuse Directors (NASADAD) Annual Meeting
May 21-24, 2018
Bethesda, Maryland
Contact: http://nasadad.org/

31st Annual Northwest Conference on Behavioral Health & Addictive Disorders
May 30 – June 1, 2018
Seattle, Washington
Contact: https://www.usjt.com/Conferences/2018/31st-Annual-Northwest-Conference-on-Behavioral-Health-and-Addictive-Disorders/

West Coast Symposium on Addictive Disorders
May 31-June 3, 2018
La Quinta, California
Contact: http://www.wcsad.com/

Categories: Events, Newsletter