BREAKING: Nonprofit Representing Psychedelic Researchers Files Post-Trial Brief Following Historic Hearing
Contact: Gina Giorgio
Director of Strategy and Development
Students for Sensible Drug Policy
gina@ssdp.org
BREAKING: NONPROFIT REPRESENTING PSYCHEDELIC RESEARCHERS FILES POST-TRIAL BRIEF FOLLOWING HISTORIC HEARING TO KEEP SCIENTIFIC RESEARCH LEGAL
Setting a Powerful Precedent: Research Harm Takes Center Stage for the First Time in DEA Scheduling Case
[Arlington, VA, January 6th, 2025] – Students for Sensible Drug Policy (SSDP) has filed its post-trial brief in a groundbreaking Drug Enforcement Administration (DEA) administrative court case that could shape the future of public health, scientific research on psychedelics, and the drug scheduling process as a whole.
The case—part of a multi-year long effort by SSDP’s Science Policy Committee to keep crucial medical research legal—challenges the DEA’s proposed scheduling of
2,5-dimethoxy-4-iodo-amphetamine (DOI) and 2,5-dimethoxy-4-chloro-amphetamine (DOC), two research chemicals vital to studies on serotonin receptors and potentially life-saving medical advancements.
This groundbreaking legal effort, led by the young leaders of SSDP, marks the first time “research harm,” or the harm caused to future and ongoing research by the agency’s decisions, will be formally considered in a DEA scheduling case, setting a powerful precedent for how such decisions impact scientific progress.
Research Harm at the Forefront
SSDP and co-petitioner Dr. Raul Ramos, post-doctoral researcher at the University of California at Berkeley whose cutting edge neuroscience research relies on DOI, argue that the placement of DOC and DOI in Schedule I would cause research harm in that it would hinder, harm, or discourage research efforts because researchers would be required to obtain a DEA registration to handle Schedule I controlled substances and adhere to the heightened regulatory requirements of the Controlled Substances Act (CSA). According to SSDP and Ramos, this would greatly increase the cost of research as well as the time required, and would prevent more experimental or cross-disciplinary research from being conducted.
Though the DEA had originally attempted to silence expert witnesses and block crucial scientific evidence—including the impact of scheduling on research—from coming to light during the two-week hearing held at the DEA’s administrative court in Arlington, Virginia in November 2024—the first of its kind since MDMA was scheduled in 1986—Administrative Law Judge Paul Soeffing allowed harms to research to be discussed in court testimony and ultimately explicitly requested SSDP address how a Schedule I designation would impede critical scientific inquiry in their post-trial brief.
“For over a century, United States drug policy has silenced scientific voices and bypassed the facts to create harmful laws rooted in misinformation and fear. The very fact that the DEA, for the first time ever, will consider the harm to research caused by scheduling is a significant victory that will indelibly shape future scheduling decisions,” says SSDP Executive Director Kat Murti. “This hearing marks a significant milestone, as it centers on the detrimental impact that restrictive scheduling could have on groundbreaking research. Adding DOI and DOC to Schedule I of the Controlled Substances Act would undermine decades of progress in neuroscience and pharmacology and SSDP and the young scientists leading this fight are committed to protecting the future of scientific and medical research.”
Following the Science: An Updated Rubric for Scheduling
In their post-trial brief, SSDP proposes an updated version of the 8-Factor Analysis required under the Controlled Substances Act (CSA), which would incorporate research harm as a crucial consideration for each of the eight factors.
SSDP further applies the 8-Factor Analysis to DOI and DOC, revealing at each step that the research chemicals lack the characteristics typically associated with high abuse potential:
1. Its actual or relative potential for abuse
Reports suggest minimal recreational use, with no clear evidence of problematic behavior or patterns of misuse.
2. Scientific evidence of its pharmacological effect, if known
DOI and DOC act on serotonin 5-HT2A receptors, similar to other psychedelics, but lack the addictive properties of substances like cocaine or opioids. Evidence shows these substances do not lead to self-administration in animals and may even reduce behaviors associated with addiction.
3. The state of current scientific knowledge regarding the drug or other substances
These substances are well-studied in research settings and demonstrate therapeutic potential, including anti-addictive effects. However, preclinical findings on DOI’s utility in treating substance use disorders and inflammation were omitted from the DEA’s analysis.
4. Its history and current pattern of abuse
DOI and DOC are rarely used recreationally, with surveys and law enforcement reports showing extremely low prevalence. Anecdotal evidence suggests occasional use but no sustained or harmful patterns of abuse.
5. The scope, duration, and significance of abuse
The long duration of effects (up to 36 hours) makes these substances impractical for recreational use. Seizure and survey data confirm minimal public use or diversion to illicit markets.
6. What, if any, risk there is to the public health
DOI and DOC have no recorded fatalities linked solely to their use. Their inclusion in Schedule I could hinder valuable research into their therapeutic potential, impacting advancements in addiction treatment and other medical applications.
7. Its psychic or physiological dependence liability
Both substances lack evidence of physiological dependence and produce no withdrawal symptoms. Claims of “psychic dependence” are speculative and not supported by robust scientific evidence.
8. Whether the substance is an immediate precursor of a substance already controlled
Neither DOI nor DOC is an immediate precursor to any controlled substance, making this factor irrelevant.
“We are using the law to bring science to the forefront, applying the best reading of the statute to ensure decisions align with empirical evidence. The science is so overwhelmingly in our favor that there’s only one logical way to rule on this case, regardless of how one views the Controlled Substances Act (CSA),” says Brett Phelps, Esq, an SSDP alum and legal counsel for the youth-driven drug policy nonprofit. “It would fly in the face of logic to ignore the science.”
The DEA’s Flawed Approach
SSDP’s updated rubric underscores the necessity of following the science and highlights the lack of scientific evidence in favor of scheduling.
The DEA, by contrast, relies on flawed logic, arguing that because DOI and DOC are similar to other Schedule I psychedelics, they should also be added to Schedule I, even without any actual evidence of abuse.
Notably, there is no evidence that any of the substances the DEA cites were subjected to the rigorous eight-factor analysis required by the CSA before being scheduled.
Lysergic acid diethylamide (LSD) and 2,5-Dimethoxy-4-methylamphetamine (DOM) were made illegal by Congress without undergoing the eight-factor analysis. And, though
2,5-Dimethoxy-4-bromoamphetamine (DOB) was scheduled through rulemaking, it remains unclear if the eight-factor analysis was conducted.
“The DEA, for reasons that are not fully transparent, is attempting to raise barriers to any and all research on the psychedelic DOI. The evidence presented by the DEA to justify its actions would not withstand scrutiny from any reputable scientific publication or establishment. This action infringes on the rights of the American people, whose tax dollars support NIH-funded research into DOI,” says petitioner and expert witness Raul A. Ramos, PhD. “ The outcomes of this work could lead to novel therapies for various neuropsychiatric conditions. However, if the DEA succeeds in implementing this proposal, the potential knowledge and advancements from this research may never come to fruition.”
Implications for Research
The outcome of this hearing could have long-lasting implications for scientific freedom and public health. DOI and DOC are essential research chemicals in pre-clinical psychiatry and neurobiology whose status as unscheduled compounds has made them de facto tools for researchers studying serotonin receptors.
DOI in particular has been a cornerstone in neuroscience research due to its high selectivity for the 5-HT2A serotonin receptor, a critical component in understanding the therapeutic effects of psychedelics.
DOI’s use in the lab ushered in a new era of psychiatric drug discovery since it was used to map the localization of an important serotonin receptor in the brain critical in learning, memory, pain and psychiatric disease. Over 80% of the antidepressant drugs on the market affect the serotonin system.
Over the past two decades, DOI has been cited in more than 900 research articles, contributing significantly to our understanding of complex neural mechanisms and offering potential pathways for breakthrough treatments. Recent studies utilizing DOI have shown encouraging results in managing pain and reducing opioid cravings, offering a beacon of hope in the ongoing opioid crisis.
“I have spent my entire Ph.D. studying DOI,” said Tanner Anderson, a neuroscience Ph.D. candidate and SSDP Science Policy Committee member. “Placing DOI and DOC in Schedule I would be a step backward for neuroscience and public health.”
Common Ground Acknowledged
While the DEA and SSDP/Ramos did not agree on much of the evidence presented, they did agree to a specific set of facts:
1. There is no diversion of DOI or DOC from legitimate channels, including research laboratories.
2. There is no evidence of physiological or psychic dependence of DOI and DOC.
3. There is no documentation in medical literature on the human use of DOI, including no reports of distressing responses or death associated with DOI.
4. It is impossible to know if anecdotal reports of people taking or selling the substances are true without analytical confirmation.
“As someone who has extensively studied the pharmacodynamics and pharmacokinetics of DOI and related psychedelics, it’s baffling to me that the government is going after DOI/DOC,” says Dr. Alaina Jaster, a pharmacologist and DOI researcher who has been involved with SSDP’s fight to keep DOI and DOC legal since 2022. “I believe that the evidence we presented and the argument we shared shows that these chemicals are not used outside of the lab and are not a danger to society. My hope is that the testimonies provided help shape a future where the DEA and FDA update their policies to be evidence based and follow current scientific literature instead of relying on archaic drug laws.”
A Call for Young Scientific Advocates
This case isn’t just about two chemicals; it’s about the integrity of science and the health of millions who stand to benefit from these discoveries. It would fly in the face of logic to ignore the overwhelming evidence and the voices of students and experts advocating for a science-based approach. SSDP’s fight to keep DOI and DOC legal is a testament that the next generation of scientists is leading advocacy roles and actively shaping the policies that impact their fields.
“None of us were experts on administrative hearings; we were just a couple of passionate scientists who wanted to make a difference. Now, our group has gone up in front of the federal government and made our voices heard,” says Dr. Elijah Ullman, a PhD pharmacologist and co-founder of SSDP’s Science Policy Committee who successfully defended his doctoral thesis in the lead-up to the November hearing. “Students should not be afraid to challenge proposed rulings or be involved in their government. You’ll find a way to make it all work with the right team. It’s important to bring truth to ‘America: ruled by the people, for the people.’”
Next Steps
DEA Administrative Law Judge Paul E. Soeffing will issue a recommendation following a review of the courtroom transcripts and submission of the post-hearing briefs from both SSDP/Ramos and the Government.
This process is estimated to take several months, but SSDP remains steadfast in its mission to advocate for evidence-based drug policies and protect the freedom of scientific inquiry.
“Our post-hearing brief exposes the DEA’s profound failure to meet its burden of proof to add these crucial research tools to Schedule I, as well as illuminating the dangers of unchecked administrative power. The proposed scheduling of DOI and DOC epitomizes the abuses of administrative authority in misguided policies that threaten to derail critical scientific progress and public health advancement. The Supreme Court’s holding in Loper Bright removes a barrier that the DEA has hidden behind for decades to misapply the Controlled Substances Act in ways that courts have acknowledged is contrary to Congressional intent,” says Robert Rush, a Denver-based attorney representing Dr. Ramos and working closely with SSDP. “We are hopeful that the tribunal rules based on the overwhelming evidence presented and current law to spare these compounds from needless restriction and allow critical research to continue that could positively benefit a tremendous number of people.”
With chapters on campuses and in communities across the country, Students for Sensible Drug Policy (SSDP) is the largest national youth-led network dedicated to ending the War on Drugs. Our national staff, Board of Directors, chapters, and alumni work together to replace the disastrous War on Drugs with policies rooted in evidence, compassion, and human rights, at a grassroots level.
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