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, we worked with experts from multiple psychiatric areas to bring you thoughtful articles about a wide variety of psychiatric issues, from research on lithium and suicide prevention to integrative medicine and nutrition for PTSD. Here are some highlights from the issue.

Federal Court Gives Green Light to Deny Coverage

Nearly every psychiatric clinician I know has experienced it: Their patient’s health plan determines—with little justification—that the needed treatment is “not medically necessary.” The clinician is then forced to spend valuable time fighting for coverage of the treatment that is validated by accepted clinical standards of care. Meanwhile, families confront their options: spending life savings, taking on burdensome debt, or going without treatment.

With more than 7.1 million American adults not receiving the mental health treatment they need because of cost, ensuring health plans cover the services patients need is essential to maintaining and increasing access to care. At the root of this issue is who makes the determinations about whether treatment is needed— and what standards should be and must be followed. 

Exploring Integrative Medicine and Nutrition for PTSD

Evidence from a growing number of studies suggests that 38% to 40% of adults living in the United States use complementary and alternative medicine (CAM) therapies, yet only 42% have told their primary physician that they do so. Patients do not disclose their use for numerous reasons. They are not asked about it; they are concerned that their clinician will disapprove; they may not think it is necessary; and/or their clinicians are not interested in or do not know about CAM methods.

Moreover, integrative medicine (IM) appeals to groups like veterans who traditionally avoid or experience dissatisfaction with conventional treatment and are prone to posttraumatic stress disorder (PTSD). Hence, clinicians should disclose their interest and training in IM and ask patients about their health practices. 

The Most Important Thing You Need to Know About Meta-Analyses

A busy clinician does not have time to read the vast number of randomized controlled trials (RCTs) published about different treatments. But good meta-analyses save us time by aggregating and summarizing data from relevant trials. Individual RCTs are sometimes small and suffer from methodological flaws. The results of RCTs are often influenced by sampling error. Good meta-analyses help us base decisions on larger numbers of subjects and reduce the effects of sampling error. To make the most of meta-analyses, we need to understand the most important information reported by a good meta-analysis. That information is the “prediction interval.” Although meta-analyses can focus on other topics, this article focuses on meta-analyses of treatments.

Using clear rules, a systematic review searches for studies on certain interventions for certain medical conditions. The authors of the study review the data from relevant studies to determine if helpful patterns can be found. 

Lithium and Suicide Prevention: More Thoughts on Recent VA Study

There has been much discussion of the recently published large (519 participants) US Department of Veterans Affairs (VA)–sponsored randomized clinical trial of lithium versus placebo to prevent suicide attempts, hospitalizations to prevent suicide, and deaths after a previous attempt. The distinguished group of investigators found no advantage for lithium, and the study was actually interrupted earlier than planned because of the negative results on preliminary analysis.

The authors concluded that “simply” adding lithium to existing medication regimens is unlikely to be effective in preventing a broad range of suicide-related events. An editorial by Baldessarini and Tondo, however, proposed instead that the findings “cannot be taken as evidence that lithium lacks antisuicidal effects” due to numerous serious limitations in the study. 

. And be sure to stay up-to-date by subscribing to the 

Do you have a comment on any of these or other articles? Have a good idea for an article and want to write? Interested in sharing your perspectives? Write to us at 

The experts weighed in on a wide variety of psychiatric issues for the October 2022 issue of Psychiatric Times.

From the Pages of Psychiatric Times: October 2022

Evidence from a growing number of studies suggests that 38% to 40% of adults living in the United States use 

 yet only 42% have told their primary physician that they do so.

 Patients do not disclose their use for numerous reasons. They are not asked about it; they are concerned that their clinician will disapprove; they may not think it is necessary; and/or their clinicians are not interested in or do not know about CAM methods.

Moreover, integrative medicine (IM) appeals to groups like veterans who traditionally avoid or experience dissatisfaction with conventional treatment and are prone to posttraumatic stress disorder (

 Hence, clinicians should disclose their interest and training in IM and ask patients about their health practices.

 for the treatment of PTSD is comprised of 18 components (

, clinicians should individualize their approach based on patients’ needs and preferences.

Stress and trauma affect all aspects of physical function: blood glucose levels, brain metabolism, energy, and altered brain structures where neurons misfire or fail to communicate. When stress dysregulates digestion, it leads to a cascade of events affecting mood, cognition, sleep, and immune function. Parasympathetic activity governs digestion, which explains why in PTSD and complex trauma, there is at least 1 associated digestive problem. 

In sympathetic arousal, the head hurts, the stomach aches, and the intestines are too active or immobilized by fear. Irritable bowel syndrome (IBS) often co-occurs with traumatic stress, and chronic gut distress can lead to PTSD.

 Similarly, there is a causal chain that links childhood abuse, dissociation, and somatization with IBS.

These often-explicable somatic symptoms represent a complex neuroimmunomodulatory communication system between the gut and the brain. Gut bacteria regulate the hypothalamic-pituitary-adrenal (HPA) axis

 and γ-aminobutyric acid (GABA) via the vagus nerve,

Patients should consider increasing healthy intestinal bacteria by eating fermented foods (eg, yogurt, kefir, kimchee, kombucha, sauerkraut, and stink eggs) or via supplementation with high-dose probiotics. Probiotics have been associated with pain reduction, suggesting an anti-inflammatory effect.

Nutritional medicine, diet, and nutraceuticals are increasingly used in psychiatry.

 antioxidants (eg, vitamin C, vitamin E, and zinc), folate, magnesium, and vitamins B6, B9, and B12 can provide core nutritional support for mental health.

 Phospholipid supplements have been found to reduce circulating cortisol, improve memory, prevent cognitive decline, and improve perceived well-being.

 Phosphatidylserine (PS) and phosphatidylcholine (PC) are concentrated in brain cell membranes and support cell structure and function. PS aids neurotransmitter activity, especially dopamine and acetylcholine, and supports cognitive function.

Brain neurons have a high demand for adenosine triphosphate (ATP),

 and their high oxygen consumption rate leads to free radicals and inflammation, which benefit from antioxidants. Mitochondria may be affected by lack of sleep, pesticides, pollutants, antibiotics, and psychotropic drugs, including selective serotonin reuptake inhibitors (SSRIs).

 Medications that are commonly prescribed to patients with PTSD (eg, statins, beta-blockers, neuroleptics, and corticosteroids) interfere with mitochondrial function, and mitochondria also suffer degradation as part of the aging process. Mitochondrial biogenesis may benefit from CoQ10, pyrroloquinoline quinone, quercetin, and carnitine.

High-intensity aerobic exercise and photobiomodulation (PBM) also enhance mitochondrial biogenesis. Exercise enhances cognition and neuroplasticity, balances HPA function, reduces inflammatory markers,

 and increases brain-derived neurotrophic factor (BDNF).

 Anaerobic exercise builds core muscle strength and lean body mass; increases metabolism, glucose uptake, and energy; and improves sleep and anxiety in individuals with PTSD.

The energetic exercises qigong and tai chi have been used with survivors of torture and have improved well-being and the quality of life in individuals with fibromyalgia.

 Yoga has been found to increase levels of gamma-aminobutyric acid in the brain.

 In one study, for example, African American female veterans who practiced 10 weekly classes of trauma-informed yoga experienced significant reductions in PTSD symptoms.

Research on PBM in individuals with traumatic brain injury (TBI), PTSD, anxiety, and sleep disorders showed improvements following treatment, with a medium to large effect in major depressive disorder.

 One animal study found that PBM treatment applied immediately after a traumatic event can prevent the development of PTSD-like fear.

There are as many systems of touch therapies as there are psychotherapies. Individuals of all ages are candidates for touch during all stages of their recovery. Different techniques of touch therapies facilitate specific responses. Bodywork and massage are also types of passive exercise that can help jumpstart activity and movement when the patient is not yet physically active. Stretching, range-of-motion rotations, pressure points, and guided breathing all reduce dissociation and begin the process of inviting individuals back into their bodies.

Massage and bodywork can decrease depression and anxiety; they have been used in children with PTSD following Hurricane Andrew,

 and in individuals with a history of trauma who are caregivers to patients with dementia.

 Rocking is a universal behavior that synchronizes the brain, accelerates and improves sleep quality, and increases sleep spindles, which are associated with being able to sleep through environmental noise.

 Continuous rocking strengthens deep sleep via the neural entrainment and enhances memory consolidation during sleep.

There is evidence that improving sleep should be a key component in addressing PTSD,

 and nutritional interventions that target the HPA axis and circadian rhythm may be helpful. Lithium orotate is core support that lengthens circadian rhythm, balancing mood, sleep, and cognitive health. A suggested dose of 10 to 40 mg daily of lithium orotate combined with methyl folate can prove beneficial.

 Combining bright-light exposure in the morning with vitamin B12 (methylcobalamin) can also help balance the circadian rhythm. Methylcobalamin enhances the light sensitivity of the circadian clock at dosages ranging from 1000 to 6000 mcg daily.

Individuals with PTSD may use cannabis to initiate sleep,

 but the literature on this has mixed results. Generally, high ratios of tetrahydrocannabinol (THC) to cannabidiol (CBD) may exacerbate insomnia, whereas higher CBD or cannabinol (CBN) may aid sleep. Some individuals benefit from a 5-parts CBD/CBN:THC 5:1 or 10:1 ratio. If pain affects sleep quality, THC has a more anti-inflammatory effect, used in a 1:1 or 5:1 ratio.

Lifetime cannabis use is more than 3 times more likely in individuals with PTSD than in those without.

 This may be due to the part cannabinoids play in helping the body regulate the extinction of conditioned fear as well as in reducing pain and anxiety.

 Low-dose THC in cannabis appears to have anxiolytic effects, whereas a high dose may be responsible for producing anxiety. Low doses reduce depression; high doses increase depression.

Adaptogens and their active extracts support HPA axis function build endurance, support immune function, and reduce fatigue. Adaptogens increase cellular respiration, aiding mitochondrial function. 

 lists the 3 criteria of adaptogenic herbs.

Common adaptogens include Panax ginseng, eleuthero (also known as Siberian ginseng), and licorice root. Ashwagandha is called the queen of Ayurveda and has been used for more than 6000 years to enhance vitality and endurance. Rhodiola (

) is the major botanical approved as an adaptogen by the Committee on Herbal Medicinal Products at the European Medicines Agency. It is a mild antidepressant and a stimulant that has been found helpful in addressing anxiety symptoms. Rhodiola is also anti-inflammatory, and it supports cognitive function. All these qualities make it a good option for supporting individuals with complex trauma and TBI.

Kava is one of the most effective botanical nervines that functions like an anxiolytic. Like benzodiazepines, kava acts on the amygdala, reducing fear and anxiety, and it is also a muscle relaxant that improves cognitive performance.

 Although kava-containing supplements have been associated with liver injuries, the aqueous extract of kava is safe; it is associated with no serious adverse effects and has no clinical hepatotoxicity.

) acts on benzodiazepine receptors, is anti-inflammatory, and may be beneficial for anxious depression.

In addition to eliminating harmful substance use, detoxification strategies can range from eliminating gluten from the diet to increasing cruciferous vegetables. The association between gluten, depression, and addiction is well established.

 Cruciferous vegetables enhance P-450 enzymes and aid liver function in individuals in alcohol and drug recovery or who have been exposed to environmental toxins.

 Detoxification also extends into cultural rituals like sweat lodges, temazcales, and saunas, which may decondition autonomic reactivity, increase adaptive immune function, and enhance bonding and attachment behaviors.

Psychedelic medicines alter the chemical transmissions and normal functions in the nervous system, leading to altered states and often transcendent or mystical experiences that may have import for the loss of hope, meaning, and purpose experienced by individuals with PTSD. These “psychointegrators” enhance the processing of essential information regarding self, emotions, social relations, and attachment behaviors, and facilitate this integration in the brain.

 Psychedelics alter functional connectivity and can potentially change the neural connections that keep individuals in chronic pain states.

Ayahuasca, N, N-Dimethyltryptamine (DMT), lysergic acid diethylamide (LSD), psilocybin, methamphetamine (MDMA), mescaline (peyote), ketamine, and ibogaine are all subjects of ongoing research in the clinical care for the treatment of depression, addictions, and PTSD-related symptoms.

Psychoeducation is integral to helping patients understand how their symptoms—physical, mental, emotional, and spiritual—arise from their traumatic experiences. The qualities of the clinical relationship—compassion, empathy, and rapport—are the foundation of successful trauma treatment. Next steps might include obtaining a personal consultation in integrative mental health—much as we do when we undergo psychotherapy prior to becoming a therapist—or exploring studies in integrative medicine for mental health by taking courses or attending conferences.

For those interested in learning more, additional resources can be found via the 

Leslie Korn Institute for Integrative Medicine

is a licensed psychotherapist and an integrative medicine clinician, scientist, educator, and author specializing in the intersection of trauma, nutrition, and chronic physical illness.

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https://assets.aarp.org/rgcenter/health/complementary-alternative-medicine-nccam.pdf

Nondisclosure of complementary and alternative medicine use to primary care physicians: findings from the 2012 National Health Interview Survey

Disclosure of complementary medicine use to medical providers: a systematic review and meta-analysis

The integrative management of PTSD: a review of conventional and CAM approaches used to prevent and treat PTSD with emphasis on military personnel

Rhythms of Recovery: Trauma, Nature, and the Body

Posttraumatic stress in patients with inflammatory bowel disease: prevalence and relationships to patient-reported outcomes

Abuse, dissociation, and somatization in irritable bowel syndrome: towards an explanatory model

8. Neufeld KM, Kang N, Bienenstock J, Foster JA. 

Reduced anxiety-like behavior and central neurochemical change in germ-free mice

9. Bravo JA, Forsythe P, Chew MV, et al. 

Ingestion of Lactobacillus strain regulates emotional behavior and central GABA receptor expression in a mouse via the vagus nerve

10. Spiller R, Shanahan F. Gut microbiota and abnormal mucosal neuroendocrine immune activation. In: Mayer EA, Bushnell MC, eds. 

Functional Pain Syndromes: Presentation and Pathophysiology

11. Sarris J, Logan AC, Akbaraly TN, et al; International Society for Nutritional Psychiatry Research. 

Nutritional medicine as mainstream in psychiatry

12. Wentz LM, Eldred JD, Henry MD, Berry-Caban CS. 

Clinical relevance of optimizing vitamin D status in soldiers to enhance physical and cognitive performance

13. Alquraan L, Alzoubi KH, Hammad H, et al. 

Omega-3 fatty acids prevent post-traumatic stress disorder-induced memory impairment

The role of nutrients in protecting mitochondrial function and neurotransmitter signaling: implications for the treatment of depression, PTSD, and suicidal behaviors

17. Jardim FR, de Rossi FT, Nascimento MX, et al. 

Resveratrol and brain mitochondria: a review

Our (mother’s) mitochondria and our mind

19. Bersani FS, Mellon SH, Lindqvist D, et al. 

Novel pharmacological targets for combat PTSD-metabolism, inflammation, the gut microbiome, and mitochondrial dysfunction

Exercise intervention in PTSD: a narrative review and rationale for implementation

21. Jiménez-Maldonado A, Rentería I, García-Suárez PC, et al. 

The impact of high-intensity interval training on brain derived neurotrophic factor in brain: a mini-review

22. Whitworth JW, Nosrat S, SantaBarbara NJ, Ciccolo JT. 

Feasibility of resistance exercise for posttraumatic stress and anxiety symptoms: a randomized controlled pilot study

A randomized trial of tai chi for fibromyalgia

24. Streeter CC, Whitfield TH, Owen L, et al. 

Effects of yoga versus walking on mood, anxiety, and brain GABA levels: a randomized controlled MRS study

25. Zaccari B, Sherman ADF, Febres-Cordero S, et al. 

Findings from a pilot study of Trauma Center Trauma-Sensitive Yoga versus cognitive processing therapy for PTSD related to military sexual trauma among women veterans

26. Lamartiniere R, Bergeron R, Aung-Din R, et al. Photobiomodulation treatment for brain disorders: posttraumatic stress disorder (PTSD) and dementia. In: Hamblin MR, Huang YY, eds. (Eds). 

Photobiomodulation in the Brain: Low-Level Laser (Light) Therapy in Neurology and Neuroscience

27. Maiello M, Losiewicz OM, Bui E, et al. 

Transcranial photobiomodulation with near-infrared light for generalized anxiety disorder: a pilot study

28. Cassano P, Petrie SR, Mischoulon D, et al. 

Transcranial photobiomodulation for the treatment of major depressive disorder. the ELATED-2 pilot trial

Photobiomodulation prevents PTSD-like memory impairments in rats

30. Field T, Hernandez-Reif M, Hart S, et al. 

Effects of sexual abuse are lessened by massage therapy

Body-oriented therapy in recovery from child sexual abuse: an efficacy study

Dissociation reduction in body therapy during sexual abuse recovery

33. Korn L, Logsdon RG, Polissar NL, et al. 

A randomized trial of a CAM therapy for stress reduction in American Indian and Alaskan Native family caregivers

34. Bayer L, Constantinescu I, Perrig S, et al. 

Rocking synchronizes brain waves during a short nap

35. Perrault AA, Khani A, Quairiaux C, et al. 

Whole-night continuous rocking entrains spontaneous neural oscillations with benefits for sleep and memory

Cognitive behavioral therapy for insomnia as a preparatory treatment for exposure therapy for posttraumatic stress disorder

Nutrition Essentials for Mental Health: A Complete Guide to the Food-Mind Connection

The coenzyme forms of vitamin B12: toward an understanding of their therapeutic potential

39. Bonn-Miller MO, Babson KA, Vandrey R. 

Using cannabis to help you sleep: heightened frequency of medical cannabis use among those with PTSD

40. McDonagh MS, Morasco BJ, Wagner J, et al. 

Cannabis-based products for chronic pain: a systematic review

42. Orsolini L, Chiappini S, Volpe U, et al. 

Use of medicinal cannabis and synthetic cannabinoids in post-traumatic stress disorder (PTSD): a systematic review

43. Kamprath K, Romo-Parra H, Häring M, et al. 

Short-term adaptation of conditioned fear responses through endocannabinoid signaling in the central amygdala

44. Marsicano G, Wotjak CT, Azad SC, et al. 

The endogenous cannabinoid system controls extinction of aversive memories

45. Rodriguez Bambico F, Katz N, Debonnel G, Gobbi G. 

Cannabinoids elicit antidepressant-like behavior and activate serotonergic neurons through the medial prefrontal cortex

New substances of plant origin which increase nonspecific resistance

"Among adults living in the United States, 38% to 40% use complementary and alternative medicine therapies, yet only 42% have told their primary physician that they do so."

“Mr Brad,” a 46-year-old, employed man, is seen in our clinic for medication management of chronic unipolar depression, generalized anxiety, and 

. At his most recent visit, he proactively shared that he was in the process of starting at-home ketamine through an online health care provider. He has tried various antidepressant and antianxiety medications, including 9 infusions of intravenous ketamine over the years for his mental health symptoms, with mixed results. His current medications include aripiprazole 10 mg, desvenlafaxine 100 mg, clonazepam 0.5 mg QID, and mixed amphetamine salts 20 mg QID. Although his symptoms have improved and he is functioning well, he still reports some mild, low-grade depression and 

Mr Brad underwent a virtual assessment with a multistate licensed online health care provider (HCP) who was physically located in another geographic area. According to the patient, he shared his medical history, medications, and current symptoms. He was not asked to sign a release, and we were not contacted by the HCP. This presented a clinical dilemma as to our role, responsibility, and liability if we continued to treat the patient with these medicines while he was receiving at-home ketamine though another provider.

There has been a recent proliferation of online health care businesses that offer at-home ketamine through virtual visits to patients suffering from a variety of mental health conditions. 

 is FDA approved for anesthesia and pain management but not for depression or any other psychiatric disorder.

 HCPs in many countries, however, can prescribe ketamine off label for nonapproved indications.

Ketamine can be rapid acting and studies have shown effectiveness in treatment-resistant depression (TRD), suicidal ideation, and other psychiatric conditions.

 The therapeutic effects are often attributed to its antagonistic effects on the NMDA receptor, 1 of 4 subtypes of inotropic glutamate receptors located throughout the central nervous system.

. The dissociative and altered state seen with ketamine may play an important role in its therapeutic benefits. Increased attention in the lay literature and on social media on ketamine as a psychiatric treatment alternative, as well as a tool to facilitate psychotherapy through its mind-expanding properties, has led more patients to seek out this potential therapy, with or without their HCP’s consent.

Simultaneously, there has been an uptick in utilization of online telehealth providers, particularly in mental health. This has been accelerated with technology advances, increased investor interest in this business model, and COVID-19 limiting in-office health care. These businesses claim to make mental health care more convenient, affordable, and accessible by offering care in locations with few mental health care providers.

Access to ketamine as a treatment option can be challenging to interested patients. Many HCPs are reluctant to suggest or use ketamine since it is not approved for psychiatric conditions. Psychiatrists more accepting of ketamine as a treatment option may not have the staff, space, training, or equipment to administer the medication in their offices. Nonpsychiatric health care practitioners including anesthesiologists, mid-level anesthetists, and other HCPs may be skilled at ketamine administration but not in managing patients with 

treatment-resistant psychiatric disorders

. Ketamine therapy can be costly since it is often not covered by insurance.

Esketamine has some similar pharmacokinetic and pharmacodynamic properties to ketamine since it is an isomer of the medication and is FDA approved for TRD and major depression with 

. Access to esketamine is limited since many insurances are reluctant to approve this treatment. Few mental health practitioners offer this treatment since they do not have the office space, comfort level, or ability to navigate the complex insurance obstacles restricting payment.

Recently, several telehealth companies have emerged offering virtual assessments and at-home ketamine delivery, including but not limited to Mindbloom, My Ketamine Home, and Smith Family MD.

 These companies specifically market to those looking for ketamine treatment. While promoting at-home ketamine for treatment of psychiatric disorders, many of these companies are led by medical directors without mental health training. Mindbloom, one of the largest such virtual, at-home services, does have psychiatric physicians on its leadership team, including 2 chairmen and vice chairmen of psychiatric hospital departments and a former chief medical officer of the US Department of Health and Human Services.

In 2008, the Ryan Haight Online Pharmacy Consumer Protection Act was passed after a 17-year-old boy died of an opiate 

 prescribed through a telemedicine consult.

 This law limited the prescribing of controlled substances through telemedicine consult without a face-to-face encounter and an adequate medical evaluation. In 2021, with COVID-19 affecting in-person health care, the Drug Enforcement Administration temporarily loosened the prescribing restrictions of Scheduled II-V controlled substances (CS).

 There is a legislative push to continue these lessened restrictions post-COVID.

“Mr Ryan” is a 65-year-old man who agreed to be interviewed regarding his experience with at-home oral ketamine prescribed through an online provider. Mr Ryan has suffered from dysthymia and mild anxiety without much relief from medication or counseling. He has used psychedelics including LSD, 

, and mescaline for spiritual growth and as a mind-expanding practice. He denies any history of recreational drug use. He reached out to 1 of the telehealth companies offering at-home ketamine after reading an article about the potential benefits of this therapy.

He paid an upfront fee for a package, which included an initial online meeting, follow-up, and exit assessment with a nurse practitioner (NP), 2 sessions with a ketamine “guide,” 6 doses of oral ketamine, and a kit that included a blood pressure cuff, eye mask, educational resources, journal, pen, and audio program to listen to during dosing.

The initial assessment was conducted virtually over 30 minutes in which he was asked about his symptoms, drug experiences, height, weight, medical history, and expectation of treatment. He had to show his blood pressure reading from his cuff. He was not asked to share his health care providers’ names, to sign releases for his HCPs, or to provide any blood work.

He was then sent 450 mg of oral dissolvable ketamine to his home. On the day of dosing, he had a virtual session with his guide during which he was told what to expect during dosing and how to take the medication, given therapeutic readings, and instructed to set an intention for the experience. He had to show his blood pressure readings and have someone else in the home with him before dosing. The guide was not online during the entire session but was available if needed. Mr Ryan was instructed to check in 1 hour after dosing.

Mr Ryan experienced a moderately high level of dissociation with no significant adverse effects. He found it to be pleasant and therapeutic. He had a follow-up visit with the prescribing nurse practitioner a few days later and was then sent all 5 remaining treatments at 750 mg per dose. He met virtually with the guide for the second session. During the last 4 sessions, he was not required to show any more blood pressure readings or to meet with the guide or the NP. He had unlimited access to the guide via texting if he desired.

After his sixth treatment, Mr Ryan had a virtual exit visit with the NP and was offered another 6 doses without a guide for a lower fee. He could pay extra for the guide as well as for an audio program for depression, anxiety, or self-esteem. Although his experience was positive overall, he did have some concerns about the level of monitoring. He would prefer an in-person, more closely supervised experience if it was affordable and available in a warm, therapeutic setting rather than a sterile, medical office environment.

At-home ketamine treatment initiated by an online provider presents many legal, clinical, and ethical challenges to HCPs and potential risks to patients. Some legal questions are whether online prescribing of ketamine, a Schedule III medication, meets criteria for the looser rules of prescribing a CS without an in-person examination, particularly if ketamine is being used for a mind-expanding, emotionally cathartic purpose. The current law states that the prescription must be for a legitimate medical purpose by a practitioner in their usual course of their professional role.

 Whether this meets that definition could be an area of debate. Additionally, by continuing their psychiatric medications and other treatment while they are receiving at-home ketamine, is a clinician giving consent to this treatment? Is a clinician liable if there are complications or drug interactions with a medication they are prescribing during at-home ketamine administration?

Issues of safety evoke clinical questions as to who should be prescribing concomitant psychiatric medicines during ketamine use. There may be medical and/or psychiatric changes related to ketamine dosing that could require alterations in the medication regimen. Although most side effects of ketamine are mild and transient, there are potentially serious safety concerns including elevations in blood pressure, anxiety, severe dissociation, 

 Long-term risks of therapeutic ketamine dosing remain unknown.

Although there are no specific guidelines for off-label ketamine administration, there are standards of care that often include a dosing range based on weight, a medical screening that typically includes baseline blood work, and, in many cases, drug screens and an EKG, along with coordination of care with the patient’s HCPs. Most clinicians dosing ketamine will follow blood pressure, pulse, and, in some cases, pulse oximetry and cardiac monitoring by a trained health care professional during each treatment. Esketamine shares many of the same risks as racemic ketamine and was approved with the restriction that it could only be administered under a Risk Evaluation and Mitigation Strategy (REMS) program.

 REMS is for certain medications with serious safety concerns to help ensure the benefits outweigh the risks. There is required registration and training for the patients, HCPs, and pharmacists. There is a 2-hour minimum observation by a medical professional and blood pressure monitoring in office with a prescriber onsite.

With the self-administration and availability of multiple dosing with at-home ketamine, there is an opportunity for intentional or unintentional overadherence and overdosing. There is a risk with combining at-home ketamine with alcohol or drugs of abuse including opiates, amphetamines, or benzodiazepines, or with legitimately prescribed medications that could have serious and life-threatening interactions.

This also raises questions as to whether oral ketamine is even efficacious in the treatment of any psychiatric condition. Ketamine been most studied with intravenous administration starting at doses of 0.5 mg/kg. There are only 2 randomized control studies looking at antidepressant efficacy of oral ketamine in which much lower doses were used than those given by many online prescribers.

 Most other studies are small case reports and series.

Oral ketamine has low and varied bioavailability (

), leading to questions such as what is the safe and effective dose to prescribe?

 Additionally, ketamine is a drug of abuse with street value. Online practitioners sending multiple doses at once puts the patients at risk of overdose, abuse, and diversion.

We made the decision to notify Mr Brad that we did not agree with his decision to undergo at-home ketamine. Our concern was whether this was an appropriate treatment for him and what we perceived was inadequate at-home monitoring. Furthermore, we were not comfortable with the concomitant use of benzodiazepines and high-dose stimulants. We suggested that if he was going to continue this treatment against our recommendation, he taper off both of those medications. We informed him that we felt it was unsafe for us to continue managing his psychiatric medications while he was self-administering ketamine at home.

This case illustrates an important issue that clinicians will likely soon confront (if they are not encountering it already). Although at-home ketamine is a reality for now, it is conceivable that similar issues may arise with other off-label or unproven therapies, including the much-hyped psychedelic medicines, becoming available to our patients. Access to these therapies, even when illegal, is becoming easier, and government agencies, medical regulatory bodies, and clinicians need to be prepared to manage these situations as they arise.

is a psychiatrist at PsychAtlanta/PsychAtlanta Research Center and on the faculty in the Department of Psychiatry at the Medical College of Georgia. Dr Banov reports disclosures as a speaker for AbbVie, Supernus, Janssen, Intracellular Therapies, and Teva. 

is an MD candidate at the Louisiana State University Health Sciences Center.

Acknowledgment: Thanks to Marla Fleming, APRN, for her assistance in this article.

1. Wilkinson ST, Toprak M, Turner MS, et al. 

A survey of the clinical, off-label use of ketamine as a treatment for psychiatric disorders.

2. Sanacora G, Frye MA, McDonald W, et al; American Psychiatric Association (APA) Council of Research Task Force on Novel Biomarkers and Treatments. 

A consensus statement on the use of ketamine in the treatment of mood disorders.

3. Berman RM, Cappiello A, Anand A, et al. 

At-home ketamine treatment initiated by an online provider presents many legal, clinical, and ethical challenges...

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