After decades of clinging to restrictive, reactionary methadone maintenance regulations, the U.S. system has finally been revised. Details on the new Substance Abuse and Mental Health Services Administration (SAMHSA) regulations as codified in Title 8 of Part 42 of the Code of Federal Regulations (CFR).
As most of my regular readers know, I am currently tapering off of methadone maintenance, a lengthy and awful process that I wouldn't wish on a revenge pornographer.
When I began this blog a few months ago, one of my goals was to start a Change.org petition to update the U.S. methadone maintenance regulations, which used to require:
Daily dosing under observation at a clinic until take-home doses were (very) slowly granted with extended abstinence
Being available with fewer than 24 hours' notice to bring all take-home doses to the clinic for a random recount and drug test at any time
Not being able to travel without prior permission to obtain travel doses or to "guest dose" at a clinic in whatever area you are traveling to
Frequent drug tests used punitively (for example, to remove take-home doses if a patient relapsed)
Agreeing not to take any other controlled substances under any circumstances, including emergency hospitalizations and childbirth
Many extra restrictions implemented by individual clinics; for example, A) constant video surveillance and regular presence of police on clinic premises; B) not being able to hug or shake hands with other patients or share cigarettes because these interactions could be used to disguise a drug hand-off; C) having to stop taking certain non-opioid psych meds, such as gabapentin and benzodiazepines; D) not drinking alcohol or using marijuana
For those of you who want to know more about day-to-day life in a U.S. methadone maintenance program, check out my "Metha-Don't" review here.
Overall, the vibe at U.S. methadone clinics has always been distinctly correctional and punitive because these programs, which dated from the late '60s, were developed for heroin addicts at a time when they were viewed as the absolute lowest, a scourge on society.
Despite European models of methadone clinics with progressive policies that boasted much higher retention and treatment success rates, U.S. methadone regulations stayed static for decades.
The Trigger
You'd think that an opioid addiction epidemic during which more than half a million U.S. citizens have died of opioid overdoses* would've been enough to precipitate change.
*107,000 Americans died of drug overdoses in 2021 alone.
This is the U.S., though, so...
In 2023, mental health issues skyrocketed across all U.S. demographics due to pandemic-related pressures. As xylazine poisoned the fentanyl supply nationwide, scheduling of gabapentin took away yet another option that addicts and clinicians had relied upon for pain and withdrawal management as well as treatment of anxiety and other psychological issues (read my article on these dual developments here).
Things were looking bleak.
Along came COVID, during which methadone clinics nationwide were forced to grant weeks' worth of take-home doses to essentially every patient because in-person, daily dosing became impossible due to social distancing measures.
Luckily, the push for change to the methadone regulations had already been gathering steam for quite some time, and the relevant state and federal agencies, as well as Columbia University and other research entities, carefully collected data about patient outcomes during this turbulent period.
The COVID datasets, which I've mentioned elsewhere on this blog, had somewhat variant findings, but overall, they demonstrated that:
Treatment retention significantly improved when patients were given more take-home doses
There were no increases in methadone overdoses when patients were given more take-homes
Diversion, defined as a patient taking extra methadone or giving or selling methadone to someone else, was minimal and did not increase
As this review article in the public health journal Lancet notes:
"Importantly, findings from research suggest this change [increased take-homes during COVID] did not result in increases in overdoses or other adverse effects among patients. On the contrary, data indicate that potentially improved treatment retention, substantial quality of life and self-efficacy improvements, reduced burden, and fewer stressful clinic encounters for patients were associated with greater take-home flexibility. Benefits were also described by treatment providers, including improved patient motivation and satisfaction in the ability to provide patient-centred care."
The data eviscerated the demeaning and discriminatory assumption that addicts could not be trusted to manage their own medication and that they would abuse any latitude they were given, an irritational belief that had been used to justify subjecting them to a punitive monitoring program that would be seen prima facie as unreasonable were it implemented in any other healthcare setting.
Consequently, the traditional arguments against policy change were blown out of the water.
Ch-Ch-Changes
In early 2024, the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) finally took action.
For those of you who are law geeks, you can find the revised regulations in Part 8 of Title 42 of the Code of Federal Regulations (CFR), titled "Medications for the Treatment of Opioid Use Disorder."
The new regulations:
Permit patients to obtain take-home doses much earlier on in treatment and in greater number; having a week or two of take-home doses should now be the norm, not the exception
Discourage using drug tests in a punitive manner (for example, by taking away take-home doses after relapse)
Encourage clinicians to start patients at higher methadone doses and increase them more quickly (an acknowledgment of the fact that the new wave of fentanyl addicts often need much higher doses of methadone to be mentally and physically comfortable compared to previous populations of heroin and prescription opioid addicts)
Permit telehealth appointments and in general shift enrollment in counseling and treatment to a patient-centered rather than provider-mandated model
Change the process for registering as an Opioid Treatment Program (OTP) and allow Physician Assistants (PAs) to prescribe methadone under certain circumstances
Patsy, who has been in a methadone maintenance program for the past decade, is unsure of how to feel about the new regulations.
"I'm glad to have more freedom, but I hope that they're not just giving me enough rope to hang myself with," she opined.
As an infuriating aside, at my clinic, patients are required to bring back these small bottles in which take-home doses are dispensed. If you fail to return one or if the label is damaged, you can lose your take-home doses.
Supposedly, this is to deter diversion, but this is incredibly stupid because anyone who wants to divert their methadone can just pour it into another container and bring the empty one back to the clinic. We have plenty of homeless patients at my clinic, and I can't imagine how hard it is for them to satisfy this requirement given their exposure to inclement weather and the frequency with which their belongings get stolen.
The Rollout
During our last one-on-one session, my counselor mentioned that the clinic's staff had just had a meeting with a representative of New York State's Office of Addiction Services and Supports (OASAS), which is supervising the rollout of the new SAMHSA regulations at the state level.
At our clinic, take-homes are already being granted much more liberally.
Among other changes, anyone who had been given one or two weeks of take-home doses during COVID is going to have those take-home doses reinstituted provided that they aren't currently using on a daily basis.
Newer patients who aren't currently daily users will be given at least one or two take-homes from the initiation of treatment, which is a huge change from the old system, which required 90 days of clean drug tests before the first take-home dose could be given, then 90 more days for each additional take-home (with take-homes lost if there were two positive drug screens within 6 months of each other; also, patients who weren't working full-time could not receive more than two take-home doses per week no matter what).
As I've mentioned elsewhere, my clinic is also going to stop testing for marijuana. Previously, it had required a medical card from patients who use weed, without which using marijuana made it impossible to get any take-homes.
Let's just say that for years, very few patients were given take-homes.
I've heard rumors that the clinic's drug-testing policy is being revamped in other ways, as well. This last change is incredibly important because these tests have a high false-positive rate, and the GCMS testing that should be used to confirm results is very expensive and often not covered by insurance, meaning that the clinic was relying on unconfirmed, antibody-based results to punish patients for relapses that might never have happened.
The sense of bustling change is noticeable at our clinic, where many of the old-guard counselors are delightfully butthurt about these reforms.
Rollout is happening gradually, in a state-by-state, clinic-by-clinic fashion, so if you're enrolled in a program, you're not likely to feel all of the changes immediately.
It's important to remember that SAMHSA sets minimal federal regulations for maintenance programs. States are still free to impose additional constraints, and individual clinics often go even further in restricting access to treatment.
However, SAMSHA has emphasized the need for timely implementation (October 2, 2024 was initially set as the date by which clinics had to bring themselves into compliance with the new regulations unless they were bound by stricter, state-level requirements).
In New York State, the changes seem to be happening very quickly, indeed.
If you are being treated at a clinic where the staff are unaware of the new regulations or are resisting their implementation, feel free to get in touch with me. We can discuss how to contact the addiction treatment regulator in your state and brainstorm other measures for encouraging your clinic to keep up with the times.
It's Not Over
To my understanding, the revised regulations do not yet address liberalizing use of controlled and non-controlled substances other than methadone for patients enrolled in treatment programs.
This is a crucial change that we still need to achieve.
Many, if not most, methadone patients have complex medical histories that involve long-term prescriptions for benzodiazepine anti-anxiety / sleep medications such as Xanax and Ativan, stimulant ADHD medication such as Adderall and Vyvanse, as well as gabapentin and many other non-controlled substances. Currently, many patients are told that they cannot use these medications if they enroll in the methadone maintenance program.
Thus, if once-a-day methadone doesn't cut it for you - which is fairly common, especially because the highly variable half-life of the drug means that it wears off for many patients partway through the day - there are very few solutions that clinics can offer.
Their response to patients who aren't doing well on methadone is always the same: We can increase your methadone dose.
Unfortunately, monotherapy with methadone isn't effective because as the patient's dosage climbs, the side effects, which include sedation, memory problems and other cognitive impairments, and constipation become more severe.
In addition, if a patient is maintained at a high enough dosage for long enough, weaning off of the drug becomes effectively impossible because of the protracted, intense withdrawal symptoms, which can last for months.
Various European countries, as well as Canada, have experimented with methadone maintenance programs that allow patients who aren't doing well on oral methadone alone to be treated with extra doses of other opioids orally or via injection.
In addition, they allow more liberal use of other controlled substances such as benzodiazepines.
Not surprisingly, such programs are more effective and have much happier patients!
We need to keep pushing to make sure that methadone patients in the U.S. aren't unfairly barred from access to other medications that will enhance the efficacy of their treatment.
Final Thoughts
This is a huge win.
I am relieved, excited, and grateful - although I already have several take-home doses per week and am tapering off of methadone, so it doesn't change much for me.
However, we need to abolish the existing methadone clinic system entirely.
No other patient group is subjected to such a punitive, corrections-flavored monitoring regime.
Imagine if the tens of millions of obese patients eating themselves to death in the U.S. weren't given their life-saving insulin or metformin if their bloodwork showed that they had eaten cheat meals; if they were forced to eat in front of a glass observation window; if eating junk food while obese were a misdemeanor or felony.
The only legitimate justification for more intense clinical control and monitoring is when a patient is a danger to himself or to others due to a psychiatric condition. This is a long-established legal standard in the U.S., and there is a high bar to prove that this is the case.
Absent definitive proof of posing such a danger, any enhanced monitoring of certain patient populations, including addicts, is presumptively discriminatory.
Moreover, we need to push for reform of the restrictions on who can prescribe medications to treat opioid dependence.
Currently, methadone can be prescribed by any licensed physician for pain; it is only when it is used for opioid maintenance treatment that it is subject to draconian restrictions.
Methadone should be just like Suboxone (buprenorphine), a partial agonist opioid also used as a maintenance medication.
Buprenorphine can be prescribed by physicians who are not addiction specialists after they take an online course to learn about the medication. It can be picked up at a standard pharmacy, and patients are quickly able to obtain a month's supply at a time.
Currently, there are limits placed on how many patients clinicians can prescribe methadone and buprenorphine to. Again, we need these quotas, which don't exist for other patient demographics and medications, increased or removed altogether.
There are still vast swaths of the country in which addicted patients don't have access to methadone clinics or buprenorphine providers with open slots in their programs.
Unfortunately, there is a powerful Opioid Treatment Program (OTP) industry association, called the American Association for the Treatment of Opioid Dependence (AATOD), which opposes any change to the current system, upon which fortunes have been made.
Previously, this group used misinformation and political pressure to oppose both the Opioid Treatment Access Act (OTAA) and the Mainstreaming Addiction Treatment (MAT) Act.
They are pushing back against the methadone clinic reforms, as well.
Until they are definitively pushed out of the picture, we run the risk of them using future setbacks to reinstitute the old, ineffective system.
There are legislators who are prioritizing the complete overhaul of the current Opioid Treatment Program system.
For example, Ed Markley, U.S. Senator (D) from Massachusetts, is sponsoring legislation called the Monitoring Opioid Treatment Access Act (MOTAA), which will allow any board-certified addiction medicine physician to prescribe methadone, which could be picked up at any pharmacy.
This measure is being vehemently opposed by both the American Society of Addiction Medicine (ASAM) and the AATOD.
I'm currently evaluating ways in which clinic patients can organize to push for further reform.
Writing letters to your senators, who will vote on MOTAA and other legislative measures, is one option. I'm thinking of creating a form letter for this purpose.
We also need to push hard to have states with more restrictive laws on their books repeal or amend them so that the relaxed federal regulations prevail.
So, let's take a moment to appreciate a huge victory, but let's not sit back and trust that the rest of the work will be done for us!
If you're enrolled in a methadone maintenance program that is currently changing its rules to implement the new SAMHSA regulations, please drop a comment below to let us know what's changing and when. If you're aware of any relevant state or federal bills that will further reform the U.S. opioid treatment system, please mention those below, as well.
If you're interested in reading more about my thoughts on methadone and buprenorphine maintenance treatment, check out "Double-Edged Sword or Sword of Damocles" here.
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