'Ketamine via Telehealth: Psychiatrists Urge Caution'

 The girl in the TikTok ad -- multiple nose piercings, 90s throwback outfit -- lies in bed sadly, eyes cast down, with the accompanying text: "Life before trying ketamine therapy with Peak." Cut to "Life after Peak": Her eyes brighter, she's bouncing around with a rainbow bagel; then smiling with an iced coffee; twirling on a sidewalk.

The video's caption: "Went from saddie to baddie thanks to Peak!"

It's the type of target marketing you'd expect on Gen Z's favorite social platform -- candid, confessional, trend-conscious. But Peak is an online service that promises a "breakthrough" with at-home ketamine treatments you can get without meeting a doctor in person.

With a few online evaluations and a payment of $359, you could have sublingual ketamine delivered to your doorstep. It's dispensed via Precision Compounding Pharmacy and can come as "troches" that look like lozenges, or rapidly dissolving tablets.

Psychiatrists and other professionals in the ketamine therapy space have questions about the rapid rise of telehealth to prescribe a drug traditionally reserved -- and off-label -- for the most stubborn cases of treatment-resistant depression. They raise concerns about the safety protocol of online-only services like Peak.

As in the case of Cerebral, a telehealth company that recently came under fire for its liberal prescribing of ADHD medication, experts wonder if the psychoactive drug is ending up in the right hands.

"I think there's something so amazing about it for certain people, in certain circumstances -- it can totally increase access, and they could get their life back," said Gail Serruya, MD, chief medical officer at the ketamine clinic she runs, Voyage Healing PC. But "marketing potentially addictive drugs is just so frightening to me. Having incentives for people to do more of it just doesn't feel right."

On Peak's site, patients can save if they buy a 3-month membership up front, as opposed to month-to-month, and patients pay before they meet with a prescriber. Other companies dispensing psychedelics via telemedicine offer similar subscription plans.

What Does Science Say About Ketamine?

Experts say ketamine has some advantages over other depression treatments. It works quickly, providing fast relief, with effects felt in as little as 15 minutes. SSRIs, on the other hand, can take weeks to work. Quick relief from suicidal thoughts could mean the difference, for some patients, between life and death. Clinicians and patients report having transformational, even spiritual experiences with ketamine.

But ketamine therapy is in its infancy, as is the scientific evidence to support its use in various contexts.

Most published data pertain to intravenous ketamine or esketamine (Spravato), the only version of ketamine (an enantiomer) FDA-approved to treat depression.

Data on sublingual ketamine are scarce -- and evidence around its self-administered use at home is non-existent.

Ketamine telehealth websites make some misleading claims. For example, Peak's website says, "Ketamine is FDA-Approved as a breakthrough treatment for mental health," which Serruya said is "simply not true." It's approved for anesthesia, but prescribed off-label for psychiatric disorders. There's also little research on the long-term effects of ketamine.

Recently, a company called Mindbloom, one of the leaders in remote psychedelic treatments, co-authored a study that touted impressive results for at-home, sublingual ketamine for anxiety and depression. But John Torous, MD, director of the digital psychiatry division in the department of psychiatry at Beth Israel Deaconess Medical Center, said, "The issue is it is a retrospective and open-label study with a large potential for bias."

And indeed, the study notes limitations such as the lack of a control group and the "self-selection of the patients," and a lack of long-term data (none beyond 4 weeks).

Nevertheless, a handful of online platforms -- Tripsitter, Nue Life, and My Ketamine Home -- offer at-home only services with long-term options.

And though dozens of ketamine clinic websites and providers report that it's "extremely safe" with "no significant side effects," the drug isn't without risks. Ketamine shouldn't be prescribed for those with hypertension because it can cause increases in both heart rate and blood pressure, something Serruya screens for carefully. It's also not recommended for people at risk for psychosis, because of the significant psychoactive effects.

Safety Concerns With Ketamine via Telehealth

Clinicians told MedPage Today that online-only platforms administering a drug that's relatively easy to prescribe (ketamine is a class III drug, the same schedule as Tylenol with codeine), pose a number of unique safety questions.

For one, it's easier to monitor a patient for potential problems in person: for example, Serruya said, to take a patient's heart rate before treatment. Mindbloom does send a heart rate monitor to their patients for remote dosing sessions, but it's unclear if other companies do. It's also important to make the setting comfortable for the patient -- a key aspect of psychedelic therapies.

Ketamine "does have a propensity to loosen and even dissolve the ego," Ryan Henner, MD, staff psychiatrist and leader of the esketamine clinic at Beth Israel Deaconess Medical Center, told MedPage Today. So, he said, "In person as opposed to over telehealth, if someone were having a distressing experience involving a loss of their sense of self, it certainly would be nice to have a supportive, understanding clinician available."

"There's a lot also about ketamine, and in the ketamine experience, that we don't understand specifically around how it intersects with psychotic experiences," said Henner, although he said providers do their best to screen out people at risk for psychosis.

"I think that's important that people aren't just taking it without anyone there," said Serruya.

Then there are the actual physical effects. According to Henner, there's a "significant loss of motor coordination at moderate to high doses." So if a patient took ketamine at home, and "God forbid something were to happen, they were to fall, they were to hurt themselves, it will be difficult for them to call for help, for instance."

It's unclear whether Peak providers monitor or require supervision for patients throughout; the company has not returned a request for comment from MedPage Today. Its website tells patients that they will "use our app to record and share your experience with our team."

Though there are no formal training requirements for prescribers to administer non-anesthetic ketamine, ketamine providers said credentials do make a difference.

Henner reviewed Peak's website, which lists a team of providers, among them one PA and two NPs, with limited information about their background with ketamine.

"It's interesting to me that they don't have an MD among them," Henner said. Though he emphasized that they could be well-qualified and experienced, "I do hope that any group offering a medical intervention of any kind has really been very thoughtful about the background of the folks who are doing the screening."

The site does note that its staff would review the medical history of a patient, but doesn't specify whether or not they coordinate care with a patient's other doctors, confirm diagnoses of depression or other psychiatric conditions, or verify other prescriptions. Peak did not respond to requests from MedPage Today about these policies.

Mindbloom has a remote ketamine program, but they require a "peer treatment monitor" or a trusted adult over 18 to be present with patients during dosing. These participants are met and coached by Mindbloom "guides" before the first session.

While that company wouldn't comment on Peak or other providers, Leonardo Vando, MD, Mindbloom's medical director and a board-certified psychiatrist, said, "it's very important to understand that like any treatment, ketamine therapy is neither a miracle cure, nor is it for everyone."

He added that the clinical advisors, clinicians, and the evaluation process are the first things to scrutinize. "If I were looking at another provider and I couldn't identify their advisors or clinical leadership, or their clinicians didn't have relevant experience, or they didn't conduct rigorous screening and evaluation, I would have concerns."

An Emerging Market

Peak appears to be in its early days as a company, Henry Bair, a research affiliate at venture capital firm GSR Ventures, told MedPage Today. Bair is also a dual MD/MBA candidate at Stanford University and is a member of MedPage Today's youth editorial board, The Lab. Bair couldn't find any information on Peak in one business database, but did find a record of seed funding for Peak for an undisclosed amount in another .

"If I were, let's say, evaluating what this company was from an investor's perspective, I would say it's too early," he said. "They don't have a proven track record, and they don't have a demonstrated credibility."

In any case, he added, he's noticed a growing interest in ketamine in the last 2 years, though in telepsychiatry "there are so few winners right now. It's hard to say what the recipe for success is." He said that psychiatrists are wary of telemedicine for now -- and perhaps for good reason.

Bair said one line from Peak's website caught his eye: "We believe that everyone has a right to choose their own modality of care. No one should tell you how you heal yourself."

"I think it'd be kind of hard to find a psychiatrist who would agree with that," Bair said, "because that's what medical practitioners are for."

https://www.medpagetoday.com/special-reports/exclusives/99944