Interview with Sa'ed al-Olimat, PharmD: How Pharmacists are Shaping the Future of Psychedelic Therapy

As psychedelic therapies continue to gain ground in the popular zeitgeist and edge closer to clinical use, pharmacists need to develop new competencies beyond traditional medication management. In an exclusive interview with Pharmacy Times, Sa'ed al-Olimat, PharmD, thinks the FDA's recent decision on 3,4-Methylenedioxymethamphetamine (MDMA)-assisted therapy highlights why pharmacists must be educators in this rapidly evolving therapeutic space.

Question: Since your last conversation with us, what new developments in psychedelic research do you think pharmacists should be aware of or paying attention to?

Sa’ed Al-Olimat, PharmD: One of the biggest developments since our last conversation is the FDA’s formal issuance of the Complete Response Letter regarding MDMA-assisted therapy. While the advisory committee vote gave some early indication of the challenges ahead, the CRL made it official that MDMA will not yet move forward to approval. The rationale provided by the FDA has sparked an important and ongoing conversation across the psychedelic research and clinical communities.

What pharmacists should be paying attention to now is less about the basic pharmacology, which remains promising and should still be a priority learning objective, but more about how psychedelic clinical trials are being evaluated. There is increasing tension between the demand for rigorous methodology and the reality that traditional double-blind designs are uniquely difficult in psychedelic research. With substances like MDMA and psilocybin, participants can often tell whether they received the active drug. This complicates blinding and raises questions about how trial outcomes should be interpreted.

This has implications far beyond MDMA alone. It affects how future psychedelic trials will be designed, regulated, and ultimately approved. Pharmacists will need to stay informed not only on drug mechanisms and interactions, but also on evolving regulatory expectations and ethical considerations. We are entering a phase where pharmacists must be part pharmacologist, part educator, and part advocate.

Q: What is your response to the FDA’s Complete Response Letter and its impact on the future of MDMA-assisted therapy?

Sa’ed Al-Olimat, PharmD: The CRL was disappointing, but it should not be viewed as the end of the road. It reflects the FDA’s cautious stance toward approving a fundamentally new treatment model, particularly one involving subjective experiences and psychotherapy.

What has been especially frustrating for many in the field is that the trial design elements cited as problematic were previously reviewed and agreed upon by the FDA through a Special Protocol Assessment. This included decisions around blinding and control conditions. MAPS conducted their trials in alignment with what the FDA had approved at the outset, only to later have those same elements cited as reasons for rejection. That raises legitimate concerns about regulatory consistency and predictability.

At the same time, the FDA’s concerns around bias and safety are not without validity. Psychedelic research does challenge traditional clinical trial paradigms, and the field may need to develop new standards that balance scientific rigor with the realities of these therapies. This could include improved active placebos, crossover designs, or greater use of objective outcome measures. With clearer expectations and refined methodologies, there remains a realistic path forward for MDMA-assisted therapy, and other forms of psychedelic therapy to come.

Q: What should clinicians know about psychedelic mechanisms of action, and what persistent misconceptions do you wish would disappear?

Sa’ed Al-Olimat, PharmD: Mechanistically, classic psychedelics like psilocybin, LSD, and DMT primarily act as agonists at the 5-HT2A receptor. This activity leads to downstream changes in brain network connectivity, including temporary disruptions of the default mode network. These changes are associated with increased neuroplasticity, emotional openness, and cognitive flexibility. MDMA works a little differently. It acts primarily as a serotonin-releasing agent and also increases levels of oxytocin and other neurochemicals involved in trust, bonding, and emotional processing.

One of the most persistent misconceptions is the idea that psychedelics alone are sufficient, or that they function as a 1-time magic pill. While these substances can catalyze powerful insights and emotional breakthroughs, the therapeutic value does not come from the molecule alone. The benefits arise from psychedelic use within a structured psychological support process that includes preparation, close monitoring during the experience, and integration afterward.

The psychedelic experience can be expansive and healing, but it can also be deeply challenging, frustrating, or emotionally intense (which can also be very healing). Yet, without a proper emotional support system and planned framework, individuals may enter the experience with unrealistic expectations or feel overwhelmed by what emerges. Without integration, even the most meaningful insights can fade or become destabilizing. Ongoing psychological and social support is critical for helping people make sense of their experiences and translate insights into lasting change.

Clinicians should understand that psychedelic-assisted therapy is not a passive pharmaceutical intervention. It is a collaborative therapeutic process in which context, support, and human connection are as important as the medication's mechanism of action.

Q: What competencies do you think pharmacists will need to develop as psychedelics move closer to clinical use?

Sa’ed Al-Olimat, PharmD: Pharmacists will need strong foundational knowledge in the pharmacodynamics and pharmacokinetics of psychedelic compounds, particularly regarding drug-drug interactions. This includes understanding which medications may blunt psychedelic effects, which combinations increase risk, and how to approach tapering decisions when appropriate.

Equally important are patient counseling skills, harm-reduction principles, and the ability to collaborate across disciplines. Psychedelic therapies do not fit neatly into existing healthcare workflows. Pharmacists should be equipped to help patients navigate expectations, understand risks, and prepare for emotionally demanding experiences in a thoughtful, nonjudgmental way. As the most accessible healthcare professional, I can envision a framework where pharmacists are trained to support a patient's journey from preparation, dose-day support, and integration. In fact, a few of my pharmacist colleagues and I have been trained and certified by MAPS in their 100-hour MDMA Therapy Training Program.

Pharmacists will need to stay informed about legal, ethical, and regulatory developments. As interest in psychedelics continues to grow, pharmacists will increasingly serve as trusted sources of accurate information and safety guidance.