Reforming Outdated Barriers to Research on Mental Health and Addiction Treatment

Written by Bridget McQuillan and Jazz Glastra

“As a researcher, I always hesitate to go into doing research with Schedule I drugs,” said Dr. Nora Volkow, Director of the National Institute on Drug Abuse, or NIDA, in 2021 (Jager, 2021). NIDA, part of the federal government’s National Institutes of Health, funds and conducts billions of dollars’ worth of research on substance abuse and treatment. So why would one of the nation’s leading substance abuse researchers and the leader of this formidable organization balk at conducting research with Schedule I substances? “It takes much longer to get the approval in order to initiate research, and it’s more costly, and that actually delays everyone’s progress.” [Emphasis added].

These problems are exactly what part of the new HALT Fentanyl Act (short for Halt All Lethal Trafficking of Fentanyl Act) tries to fix. Signed into law in July 2025, the bill does two big things: it permanently classifies fentanyl-related substances as Schedule I, and it cuts some of the red tape that prevents scientists from studying Schedule I drugs.

The first part grabbed the headlines, but the second could reshape the future of mental-health research and treatment.

Why This Matters

Schedule I is the strictest drug category in the U.S. It’s where substances like heroin and now fentanyl analogs sit, but also psychedelics like psilocybin and MDMA, which have significant medical potential. And unlike other drug categories, it’s been a notoriously difficult class of drugs to research (McKenna & Boyd, 2023). Scientists need separate licenses for each study site, every staff member requires an individual registration, and even producing small amounts of a substance for research requires additional approvals. As of 2019, it took an average of 105 days to get a DEA registration after submitting an application (Miller, 2019).

As Dr. Volkow points out, these obstacles aren’t just frustrating; they actively slow down progress. Some researchers are forced to abandon research projects altogether. For patients waiting for better treatments, that delay has serious consequences.

How the HALT Fentanyl Act Changes the System

The new law makes several changes designed to speed up research without compromising safety:

• One license can now cover multiple study sites, making large clinical trials more feasible
• Researchers with an FDA-approved clinical trial application can move forward through a notice process rather than a full registration
• Ongoing studies are protected if a substance gets rescheduled mid-trial
• Small-scale manufacturing is allowed without requiring yet another license

Individually, these sound like technical fixes. Together, they could finally turn Schedule I research into something scientists are eager to pursue.  

Could the HALT Fentanyl Act Advance Psychedelic Research?

For psychedelic research, these reforms matter. Research into psilocybin and MDMA has suggested they could offer major relief for conditions like treatment-resistant depression and PTSD (Sky, 2022), disorders that affect millions and don’t always respond to existing therapies.

But scaling these studies has been slow and unnecessarily expensive. The HALT Fentanyl Act’s reforms could make it more realistic for researchers to expand small pilot studies into large, multi-site trials—the kind needed to move psychedelic therapies closer to FDA approval.

BrainFutures’ Role

In March 2025, BrainFutures led a letter to U.S. Senate leaders supporting the research reforms contained in the HALT Fentanyl Act alongside a dozen other organizations and researchers. Our advocacy on this issue is rooted in the urgent need for innovation in mental health research. These long-overdue reforms will make it easier for scientists to study Schedule I drugs, particularly psychedelic compounds that may develop into new, lifesaving treatments for people struggling with depression, PTSD, and other mental health challenges.

What Comes Next?

Passing the law is just the beginning. BrainFutures plans to participate in the rule-making process, sharing input from researchers and mental health experts to ensure the law’s promise is not lost in implementation. As the new law rolls out, we’ll be working closely with researchers to evaluate the impact of HALT Fentanyl and advocate for further reforms, if necessary.

For all the headlines about fentanyl enforcement, the quieter story may end up being the most hopeful. The HALT Fentanyl Act marks a step forward that has the potential to accelerate psychedelic research in response to our nation’s pressing mental health crisis. While this is a significant first step, much work still lies ahead.

BrainFutures invites feedback and insights from researchers as we continue our engagement in this work. Please email info@brainfutures.org to connect.

References

Compass Pathways. (2018, October 23). COMPASS Pathways Receives FDA Breakthrough Therapy Designation for Psilocybin Therapy for Treatment-resistant Depression. Prnewswire.com. https://www.prnewswire.com/news-releases/compass-pathways-receives-fda-breakthrough-therapy-designation-for-psilocybin-therapy-for-treatment-resistant-depression-834088100.html

Jaeger, K. (2021, December 2). Top Federal Drug Official Personally Hesitates To Study Marijuana Because Of Schedule I Research Barriers. Marijuana Moment. https://www.marijuanamoment.net/top-federal-drug-official-personally-hesitates-to-study-marijuana-because-of-schedule-i-research-barriers/

Jaeger, K. (2025, August 19). DEA Advances Psilocybin Rescheduling Petition To Federal Health Officials Following Years-Long Legal Challenge – Marijuana Moment. Marijuana Moment. https://www.marijuanamoment.net/dea-advances-psilocybin-rescheduling-petition-to-federal-health-officials-following-years-long-legal-challenge/

McKenna, S., & Boyd, C. (2023). How a Drug’s Schedule I Status Restricts Research. R Street. https://www.rstreet.org/wp-content/uploads/2023/07/FINAL-schedule-1-restricted-research.pdf

Miller, L. (2019, February 6). Research and the DEA registration [PowerPoint slides]. DEA Diversion Control Division. https://www.deadiversion.usdoj.gov/mtgs/researcher_train/conf_2019/feb_2019/miller.pdf

Sky, J. (2022, February). Psychedelic Medicine: A Review of Clinical Research for a Class of Rapidly Emerging Behavioral Health Interventions. (H. McCormack, L. Raines, H. Harbin, J. Glastra, F. Wolswijk & I. Burgess, Eds.). BrainFutures. https://www.brainfutures.org/mental-health-treatment/patevidence/