June 16th, 2016
I was a patient in a very expensive, inpatient treatment program in Orange County back in the mid-2000s when I first heard of methadone. I didn’t hear about the drug, or any other maintenance options, from the program’s doctors, nurses, counselors or sponsors. Instead, I heard about it when a fellow patient—a 21-year-old from Newport Beach—disclosed that she was in for Vicodin and methadone.
“Oh man, methadone. That’s the worst,” one patient said to her.
“You’re probably going through hell right now,” said another.
This young woman hadn’t been in the building for 10 minutes and had already won the Worst Possible Withdrawal award.
I wouldn’t think about methadone again for at least a year, when two college friends I knew to be trouble suddenly got jobs and completely turned their lives around.
“We enrolled in a methadone program,” they told me.
“No you didn’t. I heard that shit is awful.”
“Yeah, well… people say that.”
Nearly 10 years later, I know better. Yet despite conclusive evidence of methadone’s lifesaving benefits, many people remain wary of the drug—even hostile.
The History of Methadone
Methadone is an opioid that was first synthesized in Germany as a pain reliever during World War II. After the war, the drug was approved for use in the United States, and pharmaceutical company Eli-Lilly began manufacturing it under the name Dolophine.
As early as the 1950s, some American doctors were using methadone to treat opioid dependence—although the most common course of “treatment” remained legal sanctions and civil confinement. The potential for the drug to become a successful and widespread treatment option wasn’t discovered until the 1960s, when Vincent Dole, MD won a New York City Health Research Council Grant to study addiction. Dole designed experiments to test a variety of options and ultimately observed that high doses of methadone could alleviate harsh cravings in opioid-dependent subjects.
Dole’s methadone program, which provided the blueprint for the modern protocol of a single daily dose, had 25,000 patients by 1971.
That same year, President Nixon, who had just declared his “War on Drugs,” began establishing federal methadone maintenance programs to address escalating public outcry around drug addiction (“Public Enemy Number One”) and concerns that soldiers returning home from Vietnam would yield an epidemic of crime. Progress stalled by 1973, when controversy over the medication led to strict government controls.
How Methadone Works
The methadone we know today is produced by several manufacturers—including Mallinckrodt Pharmaceuticals and Roxane Laboratories—and is typically dispensed as a liquid or tablet. The drug acts by binding to the µ-opioid receptor, blocking the effects of most opioids and keeping the patient from going into withdrawal.
Methadone is metabolized slowly and has very high fat solubility, making it longer-lasting than other opioids. While metabolism rates vary greatly between individuals, the elimination half-life is typically between 15 and 60 hours. As a result, most methadone patients need only one daily dose. Heroin users, in contrast, typically need three-to-four daily doses to prevent withdrawal symptoms.
The Stigmatization of Methadone
Methadone’s longer half-life makes the drug a highly effective maintenance treatment, but also fuels the common myth that methadone results in more severe withdrawal symptoms. In fact, methadone withdrawal symptoms are more prolonged than those from opioids with shorter half-lives, but also much less intense. Other common myths about the drug, largely supported only by personal anecdotes, include that it weakens bones, otherwise harms the body, or is harder than heroin to kick.
It’s no accident that I absorbed some of these myths while in an inpatient treatment program. There is a long history of debate in the recovery community about what it truly means to be “clean and sober.”
This debate came to a head in 2007, when Betty Ford convened a group of interested researchers, recovery advocates, policymakers and treatment providers to develop an initial definition of recovery for better clinical practice and public understanding. The report concluded:
It was the consensus that those who are abstinent from alcohol, all illicit drugs, and all non-prescribed or mis-prescribed medications would qualify … To be explicit, formerly opioid-dependent individuals who take naltrexone, buprenorphine, or methadone as prescribed and are abstinent from alcohol and all other non-prescribed drugs would meet this consensus definition of sobriety.
Despite this and other efforts to make the recovery community, medical system and general public more inclusive and knowledgeable about maintenance treatments, extreme and often explicit stigma remains.
Never is this more apparent to me than when I spend time working at my local needle exchange program in Orange County.
“I’m interested in Suboxone,” a woman said to me recently. “But not methadone. People tell me that’s not really being clean.”
Minutes later, an old friend from Alcoholics Anonymous approached. I was excited to catch up, but also a little surprised to see her—until she explained that she relapsed after lowering her methadone dose too quickly.
“Have you talked to your counselor about possibly going back up?” I asked.
“Well, my parents don’t like me to be on it.”
“But it works for you?”
I was saddened but not surprised. Less than 10 minutes later, like clockwork, a similar conversation emerged between a volunteer and a young man who has been trying to kick heroin in traditional inpatient programs for nine years.
“People tell me it will be the worst decision of my life,” he said when asked about methadone.
It’s a phrase I hear over and over again.
A Gold-Standard Treatment
Despite the fact that methadone treatment is often viewed as a “last stop” for people who have repeatedly “failed” in 12-step programs, it’s actually, for most people struggling with opioid addiction, the very best option available.
Decades of research connect methadone programs with significant reductions in non-prescribed opioid use, criminal behavior, needle sharing and risky sexual behavior. The World Health Organization and Institute of Medicine agree that methadone maintenance is the most effective treatment for opioid addictions, and a 2009 Cochrane review found that methadone was effective in retaining treatment and suppressing heroin use. Most importantly, methadone massively reduces mortality rates, with studies showing these rates to be between one-quarter and one-third of those for people addicted to opioids who are not on maintenance drugs.
All that said, there is certainly no one-size-fits all treatment for opioid addiction; everyone’s body chemistry and psychology responds differently. Some people report methadone makes them sleepy, others anxious. I would be lying if I said methadone changed my entire life overnight. But the internal dialogue in my head shifted drastically and very quickly, from “I would really love to change my life some day,” to “I think I can do this today.”
Tangled and Damaging Restrictions
For those who would like to try methadone maintenance, accessing the medication can be difficult. Patients are required to be present at highly regulated and specialized clinics every day for at least for the first several months of treatment, before they can “earn” the right to transfer to a physician or take doses of methadone home.
What other kind of medication has this kind of requirement?
Further, methadone patients are subject to very strict rules around payments, drug testing, counseling and medical evaluations.
As of 2012, there were more than 1,400 methadone clinics in the United States, treating more than 306,000 patients—although there are still many places in the country that don’t have a local clinic.
Clinics are regulated by a tripartite system, which means they’re subject to oversight at federal, state and law enforcement levels.
Until 2001, the Food and Drug Administration (FDA) was tasked with outlining federal guidelines, including patient eligibility, evaluation procedures, dosages, take-home doses, frequency of visits, counseling and medical and psychiatric services.
In 2001, the federal oversight of methadone programs shifted to the Substance Abuse and Mental Health Services Administration (SAMHSA). SAMHSA repealed the FDA’s regulations, which dated from 1972, and implemented a new accreditation-based regulatory system. Unlike the FDA’s system of detailed prescriptive rules, which were strict and commonly referred to as “one-size-fits-all,” SAMHSA’s accreditation system was designed with the understanding that different groups of patients could need vastly different services. The accreditation process is essentially a peer-review, conducted by specialists who perform on-site visits and evaluate each clinic’s program against SAMHSA’s standards.
While federal regulations must be met by all clinics, SAMHSA (and previously the FDA) permits individual states to enact more restrictive regulations if lawmakers see fit. The extreme and unwarranted barriers to methadone treatment almost always come at this level.
Along with federal and state guidelines, the Drug Enforcement Agency (DEA) also plays a role in methadone regulation, but only in the case of illegal distribution.
With this multifaceted approach, and despite SAMHSA’s efforts to make methadone clinics more patient-centered, quality of care can fall through the cracks. Another way of putting it: It’s chaos.
“It can be ridiculous,” says Blake, a Los Angeles County resident and methadone patient. “Just the other day I walked into my clinic to make a payment, and was told that no one on-site knew how to take my check. I didn’t want there to be a mistake so I asked when I should come back. They said the next day. Within an hour I got an email threatening to pull me from the program, since I didn’t make my payment.”
His anger resonates with me. Before I left my first program, I had six different counselors in just four months—three of whom I never met. Appointments with the doctor were often made and cancelled without any notice.
Most important, I lived in a constant state of fear that my take-home doses, which took a full year to earn, would be pulled. Take-home doses are unsupervised doses given to a patient to be taken at home on schedule for the next one-to-27 days, meaning that you don’t need to be present at the clinic every single day. The stakes were high: If my take-homes were pulled, I would lose my ability to travel, and as a result, my job.
Federal regulations dictate that take-homes may be given out at the discretion of the particular methadone clinic, as long as the patient meets certain criteria. First and foremost, the patient’s two most recent random drug tests must be negative. Second, the patient must have regular attendance without skipping doses, as well as no recent criminal activity. Third, the patient must have a stable home environment and child-proof secure lockbox to keep their doses. The number of take-home doses a patient can acquire almost always corresponds to the amount of time they have spent in treatment.
During my first two years of treatment, I worked diligently to ensure I checked all these boxes and kept my counselor abreast of travel plans with detailed itineraries. Despite all of this, I frequently got calls from the front desk, which usually went something like this:
“We need you to come in today to sign this paper.”
“I was in yesterday… You said everything was taken care of.”
“We need you to come in today.”
“I am in another state—don’t you remember? You have my plane ticket and itinerary. We talked about this. You approved it.”
“It’s required by the state. Nothing I can do. If you don’t come in today we will pull your take-homes.”
“But you can’t pull my take-homes. I’ll lose my job. Why couldn’t I sign this paper yesterday?”
“Please come in before 5 pm.”
“It’s 4:30 pm. I wouldn’t even make it if I was at home.”
“Sorry. Nothing we can do.”
By the third time something like this happened, I began looking into other programs, which, luckily, was an option in southern California.
Read more from The Influence:
Establishing New Clinics
Overall, the federal component of the tripartite regulatory landscape promotes quality of care, and is not a hindrance to the establishment of new methadone clinics. The major hindrance is state laws, which vary wildly and can be so strict that they become prohibitive.
Certain states have medical recertification requirements for patients who wish to continue comprehensive long-term methadone maintenance after a specific period of time. Some require anyone trying to launch a new clinic to obtain certificates of need, certificates of licensure, and zoning permits.
As such, the first thing a prospective methadone clinic director needs to do is determine their particular state’s regulations. These may be as simple as mirroring SAMHSA’s federal regulations, or be prohibitively restrictive to the point where no methadone clinics exist, as is the case in six US states: Idaho, Mississippi, Montana, North Dakota, South Dakota and Wyoming.
The least restrictive states tend to have regulations that simply echo the federal accreditation program designed by SAMHSA. Any additional contributions from these states typically focus on ways to evaluate and improve already-existing clinics, rather than disqualifying prospective clinics from being built through regulatory roadblocks. California, New York and Maryland all fall into this category, and as a result have the largest numbers of methadone clinics.
But the other, potentially most difficult, roadblock is NIMBY-ism (“Not In My Back Yard”). Communities in which a new methadone clinics are proposed can totally shut down plans before a single brick is laid—as was the case in Monument, Colorado, where methadone providers sued state officials for refusing to grant them a license to open such a clinic.
For this reason, SAMHSA recommends first that people interested in opening a methadone clinic first perform a community assessment, and evaluate the likelihood of such an outcome. Sadly, it is often the communities where methadone programs are most needed whose populations are most vociferously opposed.
We’re Hurting Ourselves
In light of the opioid “epidemic” and related public outcry, efforts to expand access to methadone have become more popular. Methadone programs have been proven to work, to transform and save lives, again and again. In many other countries, methadone maintenance is a central part of medical practice.
In Edinburgh, Scotland, for instance, nearly 60 percent of all general practitioners provide methadone maintenance services. As a result, an estimated 80 percent of injection drug users are enrolled in a program—compared with 15 percent in the United States.
Why this difference? The extreme and nonsensical stigmatization of methadone continues to make accessing the medication far more difficult than it should be.
It’s time for state and municipality officials to consider what is really at stake when they block the people they’re meant to serve from taking charge of their own lives.
Chelsea Carmona is a writer and activist living in Los Angeles. Her last piece for The Influence was “Celebrity-Endorsed, Client-Centered and Credentialed? The Rise of Recovery Coaches.” You can follow her on Twitter: @CarmonaChelsea.