More Protocols And Guidance Are Needed As Momentum Builds For Veterans, Psychedelics, And Mental Health

Studies and reports from the U.S. Department of Veterans Affairs (VA) and other research publications suggest that an estimated 20-30% of U.S. veterans may experience some form of mental health disorder, with depression and anxiety ranking high amongst conditions. 

According the New England Journal of Medicine, up to 14% of Operations Iraqi Freedom (OIF) and Enduring Freedom (OEF) veterans suffer from depression. Meanwhile, a survey across four primary care clinics of the Veteran Affairs Medical Centers found that 12% of veterans suffered from general anxiety disorder (GAD). And 7 out of 100 veterans suffer from post-traumatic stress disorder (PTSD). 

The Role Of Psychedelics In Mental Health Treatment

Fortunately, researchers striving to better understand psychedelics continue to unveil promising findings for the therapeutic use of a host of compounds in mental health treatment. Over the past 20 years, clinical trials have shown that, under the right conditions, psychedelic compounds like psilocybin, 3,4-Methyl​enedioxy​methamphetamine (MDMA), dimethyltryptamine (DMT), and lysergic acid diethylamide (LSD) can have a positive effect on mental health conditions like, PTSD, major depressive disorder (MDD), and GAD.

Legislatively, there's momentum for change. Proposals in Congress include directing the Defense Department to study psychedelics for PTSD treatment among active-duty service members. Representatives Alexandria Ocasio-Cortez and Daniel Crenshaw have been notable advocates for such research.

Federally, the therapeutic value of psychedelics is increasingly recognized, as well, with the FDA granting "breakthrough therapy" designations to psilocybin and MDMA. This recognition could lead to their eventual approval for therapeutic use.

The push for alternative treatments need to be part of the broader conversation on psychedelic-assisted mental health solutions for veterans. One that should include an emphasis on the urgent need for protocols, structured guidelines, and practices in the administration of psychedelic-assisted therapies from the Veterans Administration. 

The VA currently provides evidence-based treatment therapies to veterans, including Cognitive

Behavioral Therapy for Depression (CBT-D), Interpersonal Psychotherapy for Depression (IPT-D), and several others, but not guidance for the breadth of psychedelic-assisted therapies now being practiced. 

The VA's Role In Psychedelic Therapy Adoption

In 2022, an updated clinical practice guideline (CPG) from the US Department of Veterans Affairs (VA) and the Department of Defense (DoD) for the management of MDD included recommendations for newer psychedelic therapies including ketamine and esketamine. Psilocybin-assisted and other psychedelic therapies were considered, but not included or recommended in the update.

While psychedelic therapeutic programs are expected to be efficacious independent of traditional psychotherapeutic practices, they are also expected to work along side traditional evidence-based therapies to complement and enhance their effectiveness. Without federal guidelines and support for treatment, some veterans are leaving the country to engage in psychedelic-assisted therapies. 

“That’s the irony. You have veterans who have done so much for our country yet, when we find a cure, they have to leave the country to get cured,” said Rep. Lou Correa, D-Calif., who co-chairs the Congressional Psychedelics Advancing Therapies (PATH) Caucus alongside Rep. Jack Bergman, R-Mich. 

There’s been a recent, greater call-to-action for the VA to keep up with the advancement of psychedelic-assisted mental health treatment being adopted in the private sector. A timely article published by the RAND Corporation urged the VA to take a proactive approach to providing guidance for psychedelic therapies in the treatment of mental health care, or risk playing catch-up with evolving practices.

“The VA should not wait another 20 years to provide guidance on psychedelics,” the article stressed, recommending the VA consider what training its providers will need to better understand psychedelics and how they interact with conventional treatment. 

Protocols and Guidelines For Psychedelic Therapies

Psychedelics can produce intense emotional and perceptual effects. Protocols ensure that these substances are administered in a controlled, safe environment, minimizing risks of psychological distress or physical harm. This includes screening for contraindications, such as certain mental health conditions or medications that could interact negatively with psychedelics.

Psychedelic-assisted therapy protocols may be segmented into three phases:

Preparation Phase:

• Screening: Potential participants undergo thorough psychological and medical screening to identify any contraindications.

• Education: Participants receive detailed information about the effects of the psychedelic, what to expect, and the overall process.

• Set and Setting Preparation: Efforts are made to establish a comfortable, safe, and supportive environment. Participants are also prepared mentally, fostering a positive and open mindset.

Administration Phase:

• Dosing: The psychedelic is administered in a controlled dose, often determined based on the individual's body weight and psychological readiness.

• Supportive Presence: Trained therapists or guides are present throughout the experience, providing emotional support and ensuring safety.

• Monitoring: Continuous monitoring of the participant’s physical and psychological state is conducted.

Integration Phase:

• Debriefing: Post-experience, participants engage in sessions to discuss and make sense of their experiences.

• Therapeutic Support: Ongoing therapy may be provided to help integrate insights gained during the experience into the participant’s daily life.

• Follow-Up: Participants might have follow-up sessions to assess long-term effects and provide additional support if needed.

While protocols and guidelines for most psychedelic use do not yet exist within the Veterans Administration, they do in the civilian domain, and may prove ideal for adoption, or in the least, modeling at the federal level.

Cybin and the EMBARK Drug Protocols Model

Cybin Inc. CYBN, a clinical-stage biopharmaceutical company focused on progressing “Psychedelics to Therapeutics™” has developed a psychological support model that provides a support framework for patients receiving psychedelic drugs. The company is actively testing two synthetic psychedelic compounds for two mental health conditions: CYB003, a synthetic psilocybin, for treating MDD, and CYB004, a synthetic DMT, for treatment of GAD.  

CYB003 Phase 2 study results recently published by Cybin, demonstrated rapid, robust, and clinically significant reduction of depression symptoms in patients with MDD six weeks after just a two 12 mg dose of the drug, with 79% of patients in remission. 

Results Cybin CEO, Doug Drysdale told me in a written interview, “Based on psilocybin data we had expectations that CYB003 would perform well, but this magnitude of change is so unprecedented that it exceeded even my expectations.”

Cybin’s CYB004 is a deuterated dimethyltryptamine (dDMT), and was designed with the potential to overcome the limitations of DMT to be a potentially more viable treatment option for anxiety disorders. Cybin is currently conducting one of the largest Phase 1 DMT clinical trials to date. 

The company’s psychological support framework called EMBARK, is a transdiagnostic, trans drug model that can be adapted to the treatment of various mental health conditions with psychedelics. It consists of six domains:

1. Mindfulness - Developing a capacity to observe and accept internal states

2. Body-Aware - Acknowledging the body can act a as a doorway into deep healing

3. Affective-Cognitive - Supporting participants with identifying, welcoming, and experiencing affective emotional states more fully

4. Relational - Attending to the importance of relationships in healing 

5. Keeping Momentum - Integrating and translating altered states into altered traits

6. Existential-Spiritual - Translating psychedelic-occasioned spiritual experiences into resources for healing

EMBARK is also based on the four ethical cornerstones of:

1. Trauma-Informed Care - Recognizing the importance of attending to trauma in all aspects of treatment

2. Culturally Competent Care - Integrating a focus on cultural factors into all elements of treatment

3. Ethically Rigorous Care - Psychedelic medicine psychological support has a greater need for therapists to use their role power ethically

4. Collective Care - EMBARK facilitators attend to the larger context of participants’ challenges through all aspects of treatment

This, along with Cybin's advancements in psychedelic medicines CYB003 and CYB004 may offer new, effective treatments for veterans suffering from mental health disorders, and the company’s EMBARK psychotherapeutic protocols provide care providers the framework for how to integrate them. 

Together, this set of solutions is prime for VA consideration and adoption.

“Veterans can be hopeful in the progress of clinical stage drug programs like CYB003 and CYB004,” Drysdale said. “These innovative treatments and protocols may offer renewed possibilities for unmet needs in major depressive disorder and anxiety disorders.”

“To all veterans, your courage and sacrifice deserve the best care, and the progress we are seeing signify that help is on the horizon,” Drysdale related. “Never lose faith in your journey toward better mental health and we will continue to progress these programs as expediently as possible.”

Psychedelic protocols are essential for ensuring safety, maximizing therapeutic benefits, adhering to legal and ethical standards, and enhancing the scientific understanding of these powerful, therapeutic substances. More guidance is needed from the Veterans Administration to help those servicemen and servicewomen already using these alternative therapies in their own mental health treatments. 

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Andre Bourque is a Benzinga contributing columnist and the co-founder of BioVescent, a ketamine, psychedelics, and alternative medicine biopharmaceutical company. Andre’s articles have been featured in Forbes, Entrepreneur.com, HuffPo, Yahoo Finance, Ebony Magazine, and Ebony.com. 

You can connect with him on LinkedIn, Twitter, and Instagram.