Veteran and research professionals reviewing clinical-trial policy documents in a neutral meeting room
EMDRNews Article

FDA Finalizes Psychedelic Trial Guidance as VA and HHS Expand Veteran Research

By Timothy Vermillion, DSW, LCSW, BCD | July 16, 2026

The federal actions do not approve a treatment. They set expectations for clinical trials, create a five-year research partnership, and open a public hearing on implementation.

On July 13, 2026, the Department of Veterans Affairs and the Department of Health and Human Services announced a five-year memorandum of understanding on psychedelic drug research. That day, the Food and Drug Administration also announced final guidance for psychedelic clinical investigations and a September 14 public hearing; the Federal Register notice of the guidance was published July 14. Neither federal action approved a psychedelic drug product or authorized routine clinical use.

These actions concern how research is designed and coordinated, how safety and outcome data are collected, and where the public can weigh in.

What the FDA finalized

The final guidance updates a draft first issued in 2023. It covers study design, data collection and generation, and patient monitoring in trials of psychedelic drug products, including studies involving psychiatric and substance use disorders.

The document is explicitly nonbinding. It “does not establish any rights for any person and is not binding on FDA or the public.” Sponsors will still read it closely because it describes the agency’s current thinking about trials in which long dosing sessions, intense subjective effects, and difficulties with blinding can complicate the collection of interpretable safety and outcome data.

What VA and HHS agreed to do

The memorandum remains in force for five years, with an option to renew. The agencies say the partnership will support greater clinical-trial participation, staff training, collection and sharing of safety, effectiveness, and cost data, coordination with FDA, and educational resources for clinicians and patients.

VA reports that it is involved in 20 active clinical trials focused on psychedelic therapies for mental health conditions, supported by the VA Office of Research and Development and more than $23 million in external funding.

The announcements also carry important limits. VA says clinical use outside research would be considered only after FDA approval and discourages self-medicating with psychedelics or other unprescribed substances. HHS said earlier ibogaine studies identified an increased risk of serious heart-rhythm problems; planned research will evaluate whether updated dosing and administration approaches can reduce that risk.

The hearing and its deadlines

The FDA hearing is scheduled for September 14, 2026, from 12:30 to 4:30 p.m. ET. It will be held at FDA’s White Oak campus in Silver Spring, Maryland, with online attendance available by webcast.

Requests to present oral comments are due by 11:59 ET on August 21, 2026. Written comments are due by 11:59 p.m. ET on October 5, 2026. The FDA hearing page provides registration and submission instructions.

The federal materials point to system-level implementation questions involving workforce training, informed consent, safety monitoring, adverse-event reporting, post-trial follow-up, and access. These are policy and research-oversight issues, not treatment instructions. The September hearing gives veterans, family members, researchers, and clinicians a formal way to contribute experience and evidence to that discussion.

Where EMDR sits in the conversation

The VA National Center for PTSD maintains a professional review of psychedelic-assisted therapy for PTSD, updated June 2, 2026. It describes two randomized, placebo-controlled phase 3 trials in which PTSD symptom severity decreased significantly more with MDMA-assisted therapy than with placebo plus therapy. It also notes that veterans made up about 19% of each phase 3 sample, limiting how confidently the findings can be generalized to veteran populations.

For psilocybin and PTSD, the VA review says there are currently no published treatment data. It also highlights a recurring research challenge: strong drug effects make effective blinding difficult. The VA review says the Lykos psychotherapy model used in the MDMA trials has not been studied as a stand-alone PTSD treatment and is not mentioned in the current VA/DoD Clinical Practice Guideline for PTSD.

The EMDR field has nevertheless been discussing possible combinations for years. EMDRIA’s Focal Point blog published a clinician practice piece about ketamine and EMDR in November 2023 and another about psychedelic-assisted psychotherapy in September 2025. These posts document practitioner interest and safety concerns, but they are practice perspectives rather than evidence that a combined treatment is effective.

EMDR Therapy Quarterly, the journal of the EMDR Association UK, published a 2023 proposal for a 12-session psychedelic-assisted EMDR framework using EMDR phases for preparation and integration around psychedelic sessions. Its authors acknowledged that some assertions were based on anecdotal clinical experience and presented the framework as a starting point for research.

What the combined-treatment research shows—and does not show

The only published clinical dataset located for a ketamine-and-EMDR combination is a 2025 retrospective chart review of eight clients with PTSD in one private practice. Participants received low-dose sublingual ketamine during EMDR reprocessing. After four sessions, average PTSD scores on the International Trauma Questionnaire fell from 15.50 to 9.88, while average functional-impairment scores fell from 8.50 to 5.25. Within this eight-person dataset, the pre/post changes met the study’s statistical-significance threshold in paired-samples tests (p < .05).

The observed improvement is a signal worth studying, but it is not evidence that the combined intervention caused the changes or that the findings generalize beyond this sample. The review was retrospective, had no control group, and came from one private practice. Both authors disclosed that they co-developed the trademarked approach and co-founded the Ketamine Assisted EMDR Therapy Institute. They called for larger randomized controlled studies.

Ketamine occupies a different regulatory lane from the classic psychedelics discussed in the federal actions. It is an FDA-approved Schedule III anesthetic, but FDA has not approved ketamine for PTSD or for use with EMDR. Clinicians generally may prescribe an approved drug off-label when they judge that use medically appropriate; off-label prescribing does not establish safety or effectiveness for the unapproved use. The source review located no randomized trial establishing the effectiveness or safety of an EMDR–ketamine or EMDR–psychedelic combination.

What is available now

VA identifies EMDR, Cognitive Processing Therapy, and Prolonged Exposure as evidence-based trauma-focused psychotherapies recommended in the 2023 VA/DoD PTSD guideline and available in VA care. The psychedelic drug products discussed here remain investigational and are not FDA-approved for PTSD.

Federal interest is not evidence of effectiveness or safety, and a growing trial portfolio is not the same as routine access. The federal actions do not compare, rank, or establish equivalence between established trauma-focused psychotherapy and an investigational drug-assisted model. Veterans considering care now can ask their clinicians about established treatments without waiting for the psychedelic research and regulatory process to be resolved.

For broader context on veteran care, EMDRNews has reported on how veterans can ask about EMDR access through VA care and on why smoking and nicotine risk deserve attention in veteran PTSD care.

Frequently asked questions

Did the FDA approve a psychedelic treatment?

No. The FDA finalized nonbinding guidance for clinical investigations and scheduled a public hearing. Neither action approves a product or authorizes routine clinical use.

What did VA and HHS agree to do?

Their five-year memorandum establishes cooperation on clinical-trial participation, workforce preparation, data sharing, patient and clinician education, and coordination with FDA.

How can the public participate in the FDA hearing?

The hearing is September 14, 2026. Requests to present oral comments are due August 21, and written comments are due October 5. Registration and submission instructions are on the FDA hearing page.

What is the current evidence for psychedelic-assisted treatment of PTSD?

The strongest published signal cited by VA comes from two phase 3 trials of MDMA-assisted therapy, although veterans were a minority of participants. VA says there are currently no published treatment data for psilocybin in PTSD, and blinding remains a major methodological challenge.

Is there evidence for combining EMDR with ketamine or psychedelics?

Only very limited evidence. One retrospective chart review reported improvement in eight clients who received ketamine during EMDR reprocessing. It had no control group and does not establish that the combined approach is effective or safe. No randomized trial of an EMDR–ketamine or EMDR–psychedelic combination was located.

Sources

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