Integrating Ethical Practices Into Ketamine and Psychedelic-Assisted Psychotherapy

Kristin W. Roscoe, JD
Staff Attorney
The Therapist
November/December 2023

---

For some people, newness brings great trepidation, while for others, great excitement. The possible efficacy of substances such as ketamine, MDMA, and classic psychedelics to change the frontiers of psychopharmacology understandably evokes these feelings in clinicians and patients alike. Therapists who incorporate ketamine-assisted psychotherapy (KAP) or—possibly in the future—psychedelic-assisted psychotherapy (PAP) into their practices must navigate these stark contrasts while balancing their legal and ethical obligations when working with patients.

Even those therapists who do not intend to incorporate PAP or KAP into their practices should understand the legal and ethical considerations surrounding PAP and KAP since their patients and colleagues may work in this space and bring concerns into session or seek consultation. This article addresses a spectrum of legal and ethical issues that KAP clinicians and future PAP clinicians should consider when providing this type of care to patients. We are grateful to the CAMFT Ethics Committee for offering thoughtful guidance on how to apply the Code of Ethics to KAP and PAP.

Psychedelic-Assisted Psychotherapy
Humans have used psychedelics for thousands of years, but psychedelics have experienced a rather tumultuous history over the last 80 years.1 In the 1950s and 1960s, researchers studied compounds such as lysergic acid diethylamide (LSD), psilocybin, and mescaline for possible clinical therapeutic applications in treating chronic alcoholism, chronic pain, opioid dependence, and anxiety associated with cancer.2 Then, under the Comprehensive Drug Abuse Prevention and Control Act of 1970 (commonly referred to as the Controlled Substances Act), the U.S. Drug Enforcement Agency (DEA) classified psychedelics as Schedule I3 This law effectively cut off studies into the possible clinical applications of psychedelics in treating mental health conditions.

Fast forward to 2023, when—very similar to the excitement of the 1950s and 60s—science seems to be on the brink of re-legitimizing psychedelics. Most recently, a clinical trial sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) indicated promising efficacy for methylenedioxymethamphetamine (MDMA) to treat post-traumatic stress disorder.4 MAPS has indicated it will seek approval from the U.S. Food and Drug Administration (FDA) for MDMA-assisted therapy. However, we do not anticipate any determination from the FDA until the latter half of 2024.⁵ Also unresolved at this time is the issue of how the DEA might shift the classification of psychedelic substances upon FDA approval for clinical use. Regardless of the DEA classification for psychedelics, Oregon and Colorado are legalizing certain psychedelics— including psilocybin. How the federal government will approach the legal chasm between state legalization of psychedelics and federal criminalization of these substances remains unknown.

While much is uncertain, some of the clinical literature indicates an essential role for mental health counseling in support of psychopharmacotherapies.⁶ Therapists, however, should remember that even if the FDA approves psychedelics such as MDMA, the FDA regulates drugs, not psychotherapy. For this reason, much remains unknown about potential therapeutic protocols associated with these medications if the FDA approves their use.

What is Ketamine?
Ketamine is not a traditional psychedelic. Ketamine is a Schedule III controlled substance, which the Controlled Substances Act defines as having a moderate to low potential for physical and psychological dependence.⁷ Ketamine was first used in the 1960s as an anesthetic medicine for animals and, in 1970 the FDA approved it for human medical use. Ketamine is a racemic compound made up of equal parts of R-ketamine and S-ketamine. Ketamine can produce a dissociative effect, referred to in this article as a non-ordinary state of consciousness (NOSC). In the late 1990s, physicians discovered that ketamine produces antidepressant effects differently than traditional antidepressants.⁸ This discovery led to clinical trials examining ketamine’s efficacy in treating patients diagnosed with major depressive disorder (MDD) resistant to conventional antidepressants. While ketamine can produce NOSC effects, it is not commonly considered a psychedelic, and this article differentiates between Ketamine and “classic” psychedelics such as psilocybin.

FDA Approval of Ketamine for Treatment of Major Depressive Disorder
Approximately 10-20 percent of patients with MDD attempt to die by suicide over their lifetimes.⁹ Despite best efforts to optimize conventional antidepressants, some patients experience treatment-resistant MDD. In March 2019, the U.S. Food and Drug Administration (FDA) approved SPRAVATO® (esketamine) for the treatment of adults with treatment- resistant major depressive disorder who have suicidal thoughts or actions.¹⁰ SPRAVATO® is a prescription nasal spray intended to be taken with an oral antidepressant. The FDA highly regulates SPRAVATO®, which is only available through prescription and administered through a Janssen Pharmaceuticals Risk Evaluation and Mitigation Strategy (REMS) certified healthcare setting.

The SPRAVATO® protocol does not include psychotherapy.¹¹ Today, depending on the clinic where SPRAVATO® is prescribed and administered, patients may or may not receive psychotherapy during treatment.

Off-Label Ketamine Use in Mental Health Treatments
While the administration of SPRAVATO® is highly regulated, it is not necessarily what you may think of when you first think of KAP. Many providers who refer to themselves as KAP clinicians are referring to their treatment of patients taking generic ketamine (the anesthetic) off-label. A drug prescribed for off-label use means that an FDA-approved medication has not gone through additional FDA approvals to show that it is “safe” and “effective” for its new intended use.¹² Once a drug, such as ketamine (the anesthetic), is approved by the FDA, medical providers can prescribe it for an unapproved use if they deem it medically appropriate for their patient. A well-known example of off-label medication use is Botox, which is FDA-approved to treat several medical conditions, but medical providers routinely prescribe and administer off-label for cosmetic purposes.

Off-label ketamine is commonly administered to patients via infusion through an IV, an intramuscular injection, an oral sublingual troche (medicated lozenge), or an intranasal spray. On February 16, 2022, the FDA issued an alert regarding potential risks associated with compounded ketamine nasal spray (not to be confused with PRAVATO®).¹³ The FDA highlighted a “lack of standardized safety measures associated with the use of compounded ketamine nasal sprays” that could put patients “at risk of serious adverse events and potential misuse and abuse.”

As of the writing of this article, ketamine is the only legal psychedelic-like drug legally available to treat MDD outside of a formal government-approved clinical trial. An internet search reveals ketamine is being advertised for the off-label treatment of such conditions as depression, anxiety, chronic pain, PTSD, OCD, and alcohol and substance dependencies—to name a few. The treatment plans can differ as there is no FDA-approved protocol for such off-label ketamine treatments. The research supporting the efficacy of KAP for these diagnoses varies widely in their study design and intervention structures and often has small sample sizes—all of which may limit firm clinical conclusions. For these reasons, patients with the same condition who are being treated with KAP in different settings may receive varying dosages at different frequencies and durations, with or without supportive psychotherapy.

The Therapist’s Role in KAP
When a patient is prescribed ketamine off-label, a KAP therapist’s role in their treatment may vary considerably, depending on the treatment setting. A clinician providing KAP may engage the client/patient by:

• Conducting a clinical intake interview and psychosocial assessment of the patient;
• Providing integrative treatment planning;
• Providing psychological preparation before administration of ketamine;
• Providing psychological support during administration of ketamine;
• Providing integrative psychological support after the ketamine administration; or
• Managing any psychological or psychiatric emergencies arising during ketamine treatment.¹⁴

KAP practitioners often use the terms “set,” “setting,” and “integration” in their work with patients. “Set” refers to a patient’s mindset. This includes such considerations as a patient’s intentions, beliefs, and emotional and cognitive states before receiving ketamine. “Setting” refers to the physical and social environment in which the patient will experience the administration of ketamine. This reference may include music, lighting, and who is in the room when the patient takes ketamine. The therapeutic processing conducted after a patient is administered ketamine is referred to as “integration” as the KAP clinician works to help the patient integrate the non-ordinary experiences induced during treatment into the patient’s overall worldview and life experience.

A KAP therapist may work in a clinic, for example, where they can treat the patient before, during, and after the administration of ketamine. In this case, the therapist will likely hold at least one session with the patient before ketamine administration to work on “set.” Later, the therapist may “hold space” for the patient during the ketamine administration while the patient is experiencing a non- ordinary state of consciousness (NOSC). Holding space refers to the idea that the patient can focus taking care of themselves, while the therapist holding space provides indirect support by bearing witness to the patient’s journey. Holding space is generally considered an essential aspect of most therapies where a NOSC is anticipated. Depending on the dosage the patient receives, they may or may not be able to speak once they begin to feel the effects of ketamine. Let us suppose the patient can speak. In that case, the therapist holding space may remind the patient of their “set” when it is clinically appropriate. In another example, the therapist may remind the patient of pre-agreed upon conditions of treatment (e.g., a therapist might remind a patient attempting to leave that they agreed to stay until cleared to go) or document the patient’s NOSC for the later integration work.

Once a patient has “landed” or come down from the most significant effects of the ketamine, the therapist may provide an integration session at that time or wait until a later date. Whether a patient receives additional ketamine administration or integration sessions will be at the clinical discretion of the prescribing medical provider. Depending on the circumstances, these decisions may or may not be made in consultation with the KAP clinician.

Treatment Settings, Risk Factors, and Safety Issues
Let us now take a tour of “worst-case scenario land.” I do not recommend it for an extended trip, but clinicians should put it on their “to visit” list when an aspect of their practice changes. As discussed above, the circumstances under which a medical provider may prescribe or administer ketamine to a patient vary widely. From the tightly regulated use of SPRAVATO® in a REMS-certified clinic to a patient self- administering ketamine lozenges in their own home while seeing a therapist via telehealth, the risks and safety concerns vary significantly across settings.

For therapists providing KAP or PAP, CAMFT recommends that clinicians reflect on how they provide care to determine those risk factors and safety concerns that might arise. For example, if a patient, while in a non-verbal NOSC, experiences an adverse medical event during a KAP session provided via telehealth, how will the therapist know and has the therapist accurately documented the patient’s physical address at the outset of the session to enable first responders to render necessary aid promptly? Similarly, if a patient is being seen in a therapist’s office and experiences a medical emergency, is a therapist rendering CPR protected by California’s Good Samaritan laws since performing CPR is outside their scope of practice? While CAMFT recognizes KAP therapists may currently provide supportive psychotherapy services via telehealth to patients experiencing a NOSC in settings unmonitored by medical personnel, CAMFT currently recommends against such practice given the possible risks to both patient and clinician. Further, clinicians should consult with their malpractice insurance provider to determine policy coverage when providing KAP to patients.

Legal and Ethical Considerations Regardless of treatment modality, Marriage and Family Therapists must be guided in their treatment of patients by the CAMFT Code of Ethics and California law. The following discussion of the ethical and legal considerations when providing KAP or future PAP is not exhaustive, rather serves as a starting point for clinicians in this space.

Scope of Practice
First and foremost, KAP/PAP clinicians must be guided by their scope of practice as detailed in the Business and Professions Code.18 California-licensed Marriage and Family Therapists are expected to understand psychopharmacology in the treatment of mental health conditions. It is, however, outside the scope of practice for a California-licensed Marriage and Family Therapist to administer, prescribe, or recommend any drug or medication. A Marriage and Family Therapist should serve as a non-medical member of the patient’s larger treatment team. In practice, a therapist providing concurrent medical care, such as blood pressure monitoring, would be doing so outside of their MFT scope of practice. CAMFT strongly recommends that therapists who provide KAP/PAP to their patients do so in a treatment setting that provides medical oversight for patient care to avoid possible allegations of providing care outside their scope of practice.

Scope of Competence As with any treatment modality, clinicians providing KAP or PAP, must be able to articulate their competency to do so. The Board of Behavioral Sciences does not require specific formal training or coursework for a clinician to gain the requisite competency to offer and provide KAP or PAP to patients. Without standard training requirements, some clinicians may gain competency by enrolling in an extensive certification program. While a clinician could—in theory—only take a 2-hour CEU course on psychedelic therapy prior to offering KAP/PAP, CAMFT would caution against such minimal training as sufficient for a clinician to gain competency to provide KAP/PAP. CAMFT recommends therapists consider receiving training from multiple training sources, consult with seasoned KAP clinicians, and consult with CAMFT to ensure they have a well-rounded understanding of the subject.

Pre-licensed therapists who wish to engage in KAP must ensure their BBS clinical supervisor is equally or more competent in providing KAP. In sum, if the supervisor of a pre-licensee does not have the competency to provide the care, their supervisee can only offer that type of care if and when they receive appropriate supervision from a BBS supervisor with that level of competency.

Clinicians who practice KAP/PAP or who contemplate doing so should be aware of the following sections of the CAMFT Code of Ethics and California Law concerning Scope of Competency:

5.11 SCOPE OF COMPETENCE:
Marriage and family therapists take care to provide proper diagnoses of psychological disorders or conditions and do not assess, test, diagnose, treat, or advise on issues beyond the level of their competence as determined by their education, training, and experience. While developing new areas of practice, marriage and family therapists take steps to ensure the competence of their work through education, training, consultation, and/or supervision.

7.4 COMPETENCE OF SUPERVISEES:
Marriage and family therapists assure that the extent, quality and kind of supervision provided is consistent with the education, training and experience level of the supervisee.

Business and Professions Code section 4980.43.1: Supervisors must ensure that the extent, kind, and quality of counseling performed is consistent with the education, training, and experience of the supervisee. Code of Regulations 1833.1: The supervisor shall be competent in the areas of clinical practice and techniques being supervised.

Supervision of Pre-licensees Vignette
Sara is a Registered Associate under the supervision of Michael. Michael completed a three-hour continuing education course on the history of psychedelics and their possible clinical applications. Michael’s coursework did not specifically address how to support a KAP patient clinically. Sara wishes to engage in KAP with patients at Michael’s private practice and has completed a comprehensive certification course addressing aspects of KAP included in Michael’s coursework. However, the course taken by Sara included considerable content focusing on the therapist’s role in providing clinical support to the client/patient during KAP.

Discussion
Under this scenario, while it is up to Michael to determine whether he has attained sufficient competency, he may feel competent to treat KAP patients only after obtaining additional training regarding what is expected of him as a psychotherapist when working with KAP clients/patients. If Michael has not had an opportunity to receive sufficient education or training to treat KAP patients, he similarly would be unable to supervise Sara’s treatment of KAP patients. If Sara wishes to provide KAP to patients, she must find a BBS supervisor with sufficient competency to supervise that KAP work.

Michael needs to understand what experienced KAP/PAP therapists ordinarily do when working with KAP/PAP patients. Unfortunately, obtaining this understanding is a complex task because there are many examples of KAP/PAP therapy and numerous variables to consider, including the nature of the treatment setting. Members of CAMFT should not overlook the wealth of information offered by CAMFT, including workshops and access to peer-reviewed journal articles through the EBSCO Psychology and Behavioral Sciences collection.19 Ultimately, once Michael feels he has obtained sufficient competency to treat KAP patients, he may supervise Sara’s treatment of those patients.

Informed Consent for Treatment Informed consent is the bedrock of all clinical work with patients. The specifics of informed consent should reflect the setting and the therapist’s role in the patient’s treatment. A therapist should be able to clearly articulate their clinical role in KAP, particularly highlighting their role if the therapist is holding space for the patient. The therapist should reflect on whether the patient truly comprehends the services offered and whether the patient benefits once KAP begins.

An informed consent that is not reflective of a clinician’s actual practice, for example, referring to risks associated with ketamine taken via sublingual lozenge when in practice the ketamine is administered intravenously, would not likely provide the patient with adequate information to make an informed decision. Importantly, while a patient may choose to ingest any substance or medication, a therapist should refrain from recommending the patient do so.

Furthermore, clinicians working with patients likely to experience a NOSC should consider whether the patient can consent once the medication has been administered.

Here are key sections of the CAMFT Code of Ethics concerning informed consent that therapists should consider in their work with KAP patients:

1.9 CLIENT/PATIENT AUTONOMY: Marriage and family therapists respect client/patient choices, the right of the client/ patient to make decisions, and help them to understand the consequences of their decisions. When clinically appropriate, marriage and family therapists advise their client/patient that decisions on the status of their personal relationships, including separation and/or divorce, are the responsibilities of the client/ patient.

Section 3 Informed Consent and Decision Making: Marriage and family therapists respect the fundamental autonomy of clients/ patients and support their informed decision- making. Marriage and family therapists assess their client’s/patient’s competence, make appropriate disclosures, and provide comprehensive information so that their clients/ patients understand treatment decisions.

3.1 INFORMED DECISION-MAKING: Marriage and family therapists respect the rights of clients/patients to choose whether to enter into, to remain in, or to leave the therapeutic relationship. When significant decisions need to be made, marriage and family therapists provide adequate information to clients/patients in clear and understandable language so that clients/patients can make meaningful decisions about their therapy.

3.3 RISKS AND BENEFITS: Marriage and family therapists inform clients/patients of the potential risks and benefits of therapy when utilizing novel or experimental techniques or when there is a risk of harm that could result from the utilization of any technique.

3.11 TREATMENT ALTERNATIVES: Marriage and family therapists discuss appropriate treatment alternatives with clients/ patients. When appropriate, marriage and family therapists advocate for the mental health care they believe will benefit their clients/ patients. Marriage and family therapists do not limit their discussions of treatment alternatives to what is covered by third-party payers.

Informed Consent Starting and Stopping Medication Vignette Sienna practices KAP in a ketamine infusion clinic run by a board-certified anesthesiologist. Jason is a patient at the clinic who is receiving ketamine infusion treatment for chronic pain. As part of her work, Sienna meets with Jason before his infusion to better understand his therapeutic goals stemming from the ketamine infusion. In session, Jason shares that he has long battled depression and typically takes an antidepressant prescribed by his psychiatrist. However, Jason stopped the antidepressant a few weeks earlier as he felt the medication no longer mitigated his symptoms. Jason states that he has not yet shared with his prescribing psychiatrist that he will be embarking on KAP, but he is hopeful that it will improve not only his chronic pain but also the symptoms of his depression. Sienna recommends that Jason update his psychiatrist on the discontinuation of his antidepressant and consider seeking a second opinion from his psychiatrist on the administration of ketamine to treat his depression.

Discussion
Here, Sienna appropriately considers that Jason may benefit from further discussion with his psychiatrist as to whether he needed to stop his prescribed antidepressant while receiving ketamine infusion treatments. As Jason was primarily prescribed ketamine by the board-certified anesthesiologist for the treatment of his chronic pain, Sienna suggests that Jason may benefit from input given by a physician who is board-certified in psychiatry and neurology as to whether ketamine is appropriate to treat his ongoing symptoms of depression.

Informed Consent When Experiencing a NOSC Vignette
Later that week, Jason presents to the clinic for his first ketamine infusion. He expresses anxious excitement about embarking on KAP with Sienna, who reminds him of her role as a KAP therapist, which they had discussed at the earlier session. Once the infusion begins, Jason conveys to Sienna that he’s starting to feel NOSC effects from the medication, and she reminds him of the intentions he set for the session. An hour into the infusion, Jason begins to experience nausea, a potential side effect of the medication, and a nurse practitioner attends to him by administering anti-nausea medication. Despite this, Jason says he wants to stop the infusion. Sienna gently reminds him that he consented to receive the treatment. While Jason is initially reluctant, he agrees—while under the effects of the medication—to continue treatment.

Discussion
Before the administration of ketamine by the medical professional, Sienna appropriately reiterates for Jason the professional role she will play. She assists Jason in his healing during the administration of ketamine by reflecting his original intentions for the session as he begins to experience a NOSC. Sienna is correct that Jason consented to the ketamine treatment while not under the effects of any medication. However, afterward she should reflect on whether Jason was competent to continue consenting to the treatment once he began to experience a NOSC. Similarly, she should consider what to do if a patient not only voices their desire to depart but also makes a physical movement to leave. A clinician who physically restrains a patient from leaving their office may face false imprisonment or kidnapping claims. Before embarking on KAP that involves a NOSC, the therapist should consider reminding the patient of the clinician’s obligation to breach confidentiality if the patient becomes a danger to self or others.

Boundary-Related Issues
Marriage and Family Therapists should only provide care within the scope of their work as a psychotherapist providing KAP/PAP. Therapists should exercise caution when discussing pharmaceuticals with patients, particularly as they relate to any possible benefits or risks associated with using such medication. Patients need to know that while their therapist is a healthcare provider, they are not a medical professional. If patients have any medical questions, like how a drug may affect them or how to handle side effects, they should ask their prescriber.

Patients may experience ketamine and other drugs in ways that increase the possibility of boundaries being tested. Clinicians should have a heightened awareness of the patient’s potential vulnerabilities when under the influence of ketamine or psychedelics. Therapists must not engage in sexual relationships with current patients or with former patients within two years of treatment. In addition to the CAMFT Code of Ethics sections 4.4 and 4.5, detailed below, Business and Professions Code section 729 declares that any psychotherapist “who engages in an act of sexual intercourse, sodomy, oral copulation, or sexual contact with a patient or client... is guilty of sexual exploitation,” which is a public offense punishable by a fine or imprisonment. Clinicians must be steadfast in their professionalism, particularly when a patient is experiencing a NOSC that potentially makes them susceptible to their therapist’s undue influence.

These important sections of the CAMFT Code of Ethics address boundary-related issues that may arise when providing KAP:

SECTION 4. DUAL/MULTIPLE RELATIONSHIPS: Marriage and family therapists establish and maintain professional relationship boundaries that prioritize therapeutic benefit and safeguard the best interest of their clients/patients against exploitation. Marriage and family therapists engage in ethical multiple relationships with caution and in a manner that is congruent with their therapeutic role.

4.4 NON-PROFESSIONAL RELATIONSHIPS WITH FORMER CLIENTS/PATIENTS: Prior to engaging in a non-sexual relationship with former clients/ patients, marriage and family therapists take care to avoid engaging in interactions which may be exploitive or harmful to the former client/patient. Marriage and family therapists consider factors which include, but are not limited to, the potential continued emotional vulnerability of the former client/patient, the anticipated consequences of involvement with that person, and the elimination of the possibility that the former client/patient resumes therapy in the future with that therapist.

4.5 SEXUAL CONTACT: Sexual contact includes, but is not limited to sexual intercourse, sexual intimacy, and sexually explicit communications without a sound clinical basis and rationale for treatment. Sexual contact with a client/patient, or a client’s/patient’s spouse or partner, or a client’s/patient’s immediate family member, during the therapeutic relationship, or during the two years following the termination of the therapeutic relationship, is unethical. Prior to engaging in sexual contact with a former client/patient or a client’s/patient’s spouse or partner, or a client’s/patient’s immediate family member, following the two years after termination or last professional contact, the therapist shall consider factors which include, but are not limited to, the potential harm to or exploitation of the former client/patient or to the client’s/patient’s family, the potential continued emotional vulnerability of the former client/patient, and the anticipated consequences of involvement with that person. (See also section 7.2 Sexual Contact with Supervisees and Students.)

4.7 EXPLOITATION: Marriage and family therapists do not use their professional relationships with clients/patients to further their own interests and do not exert undue influence on patients.

Conclusion
The importance of clinicians working within their scope of practice and scope of competence when providing KAP cannot be understated. While there are legal avenues for providing KAP, at this time, the lawful provision of PAP is limited to formal clinical trials. As new therapeutics are developed and approved by the U.S. Food and Drug Administration, our understanding of how supportive psychotherapy can be ethically provided to KAP or PAP patients will also evolve. CAMFT strongly encourages its members to call CAMFT’s legal department to discuss relevant legal and ethical issues arising from KAP or PAP.

---

Kristin W. Roscoe, JD, is a staff attorney at CAMFT. Kristin is available to answer member calls regarding legal, ethical, and licensure issues.

---

Endnotes

¹ George, et al., 2022.
² Andersen, et al., 2021.
³ United States Drug Enforcement Administration, Drug Scheduling, https://www.dea.gov/drug-information/drug-scheduling.
⁴ See A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD, https://clinicaltrials.gov/ct2/show/ NCT03537014; and Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression, Goodwin, et. al. (2022), https://www.nejm.org/doi/full/10.1056/NEJMoa2206443
⁵ See Nature Medicine, MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial (Sept. 14, 2023), https://www.nature.com/articles/s41591-023- 02565-4.
⁶ Garcia-Romeau and Richards, 2018.
⁷ Department of Justice/Drug Enforcement Administration Drug Fact Sheet Ketamine (April 2020), https://www.dea.gov/sites/ default/files/2020-06/Ketamine-2020.pdf.
⁸ Kohtala 2021.
⁹ Holma et al., 2010; Hasin et al., 2018.
¹⁰ FDA approves new nasal spray medication for treatment- resistant depression; available only at a certified doctor’s office or clinic (March 5, 2019), https://www.fda.gov/news-events/ press-announcements/fda-approves-new-nasal-spray-medication- treatment-resistant-depression-available-only-certified.
¹¹ Spravato package insert, https://www.janssenlabels.com/ package-insert/product-monograph/prescribing-information/ SPRAVATO-pi.pdf.
¹² Understanding Unapproved Use of Approved Drugs “Off Label”, https://www.fda.gov/patients/learn-about-expanded-access-and- other-treatment-options/understanding-unapproved-use-approved- drugs-label. 13 FDA alerts health care professionals of potential risks associated with compound ketamine nasal spray (Feb. 16, 2022), https://www. fda.gov/drugs/human-drug-compounding/fda-alerts-health-care- professionals-potential-risks-associated-compounded-ketamine- nasal-spray.
¹⁴ KRIYA, Guidelines (Dec. 13, 2020), https://www.kriyainstitute. com/guidelines/.
¹⁵ As of the writing of this article, PAP is not currently legal outside of formal clinical trials. Should that change in the future, PAP clinicians may be guided by these liability scenarios to the extent there is alignment with FDA-approved protocols.
¹⁶ CPH & Associates Sample Policy specifically excludes claims “arising out of any criminal, dishonest, fraudulent or malicious act or omission.”
¹⁷ See In the Matter of the Accusation Against: Eyal Goren, Decision and Order, OAH No. 2022070626 https://search.dca.ca. gov/downloadd0022f2a848132072353c15edbad3c5b03d6845842 d435a4457c0b4a47ca22cfbb3741072628f9967eaae554af254b700 3b05a5b026eec53293305daa6ddc13e, which resulted in the surrender of the therapist’s license after allegedly providing “Underground Psychedelic Therapy” to two patients effective March 9, 2023.
¹⁸ Bus. & Prof. Code section 4890.02.
¹⁹ The EBSCO Psychology and Behavioral Sciences collection may be accessed by members of CAMFT at: https://www.camft. org/Education/EBSCO/EBSCOhost

---

This article is not intended to serve as legal advice and is offered or educational purposes only. The information provided should not be used as a substitute for independent legal advice and it is not intended to address every situation that could potentially arise. Please be aware that laws, regulations and technical standards change over time. As a result, it is important to verify and update any reference or information that is provided in this article.