News
Inside the Addiction Medicine Pipeline: Breakthrough Treatments on the Horizon
This blog is part of ASAM’s ‘Recovery Readout’ series, which breaks down the latest data and trends impacting addiction medicine and practice management.
Data in Focus
There are about 6,000 active clinical trials in the US with medication as the intervention tested per NIH’s online database.
Yet, only about 2% of them are studying medications to address substance use disorders (SUDs) or about 100 of the ~6,000.1
Interestingly, almost 60% of ongoing clinical trials for medications are at phase 2 or beyond2, a phase that signifies the interventions have met a human safety threshold and are now being evaluated for their effectiveness.
Studies for medications to address opioid use disorder (OUD) are the largest group of phase 2+ studies, followed by studies for alcohol use disorder (AUD).3
However, that’s compared to all medication trials in the NIH database that are phase 2 and beyond (~73%).4
Zoom Out
The large share of SUD trials at phase 2 or beyond show a field that is maturing and showing signs of real breakthroughs with these studies now testing effectiveness, not just safety.
And the drug‑development pipeline for substance use disorders appears to be more mechanistically diverse than in past years, with trials involving Glucagon-Like Peptide-1s (GLP-1) and psychedelics making up almost 40% of ongoing SUD clinical trials.5
Psilocybin appears to be the most tested psychedelic, and the Trump Administration has signaled interest with a petition from the Drug Enforcement Administration (DEA) to reschedule the substance to schedule 2 from schedule 1.
As for GLP-1s, there are 11 ongoing clinical trials with 10 in phase 2 and 1 in phase 3 that is testing the use of semaglutide for AUD in veterans.6
GLP-1s to address opioid, alcohol, tobacco, cocaine, and methamphetamine use disorders are all currently being studied in phase 2 effectiveness studies.
The data also point to a problem that has continued to frustrate the field: despite stimulant and polysubstance use driving overdose deaths, they remain the least represented conditions in the drug pipeline. Only about 15% of ongoing trials are focused on stimulants and less than 1% are focused on polysubstance use. Compare that to alcohol and opioids which make up more than 90% of the current portfolio.7
The Impact
The addiction medicine pipeline of new medications to address SUDs are showing real promise, but the field still lags the broader clinical development environment.
SUD impacts more than 16% of the US population.8 Still less than 4%9 of the National Institute of Health’s (NIH) current budget10 is dedicated to National Institute on Drug Abuse (NIDA) and National Institute on Alcohol Abuse and Alcoholism (NIAAA) that study interventions to address it.
Nevertheless, GLP-1s and psychedelic-type therapies make up a substantial portion of the current research portfolio, indicating that scientific momentum and research investment appear to be coalescing around these innovative therapies.
GLP-1s have real practical implications for SUD treatment given they are not controlled substances that would be restricted by federal and state regulations.
And non-specialty prescribers are very familiar with them, removing a barrier that has particularly frustrated efforts to integrate primary care with existing OUD treatment regimens.
Nevertheless, there’s also considerable policy, coverage, and reimbursement challenges associated with these medications, something that clinicians that treat SUD are all too familiar with.
Not to mention, in the case of psychedelics, most drugs in that class remain at schedule I federally (no accepted medical use/high potential for abuse), complicating research advances, increasing operational and financial barriers, and complicating coverage and payment policies.
Takeaways
Industry is investing significantly in GLP-1 products, and clinicians treating addiction should prepare for the high possibility that GLP-1s will become the first new SUD treatment regimen since innovations in treatment with buprenorphine that brought about the injectable product.
Although there have been considerable efforts to engage primary care with current treatments with limited success, encouraging trial results so far mean a change to the current paradigm in where SUD is addressed, given that primary care docs are already prescribing these meds.
While psychedelic trials are showing promise, their use, if approved by the FDA, face significant regulatory and operational hurdles.
Care coordination may become more important as these promising trials, especially GLP-1s, prove effective for addressing a multitude of conditions, not limited to SUD. That could mean the need for more interprofessional consultations and integrated care.
The coverage, payment, and regulatory landscape for these emerging breakthrough medications are not uniform. Given the documented challenges to accessing existing treatment options, policymakers may need to consider concerted updates to ensure patients with a SUD can access them.
Stories Behind the Stats
- The surprising new use for GLP-1s: Alcohol and drug addiction
- GLP-1s have transformed weight loss and diabetes. Is addiction next?
- GLP-1 drugs protect against new or worsening addictions, large study shows
- White House strikes deals for lower prices on obesity drugs
- Patients Face New Barriers for GLP-1 Drugs Like Wegovy and Ozempic
- ’Shrooms Lead the Pack in Psychedelic Medicine, but Rollout Is Bumpy
- DEA Advances Psilocybin Rescheduling Petition To Federal Health Officials Following Years-Long Legal Challenge
Go Deeper
- Glucagon-like peptide-1 receptor agonists and risk of substance use disorders among US veterans with type 2 diabetes: cohort study
- The potential role of GLP-1 receptor agonists in substance use disorders – a systematic review
- Psychedelic medicine: mechanisms, evidence, and translation to practice
1 ASAM staff analysis, supported by Copilot review, of NIH’s ClinicalTrials.gov database showing that of approximately 6,000 active U.S. medication‑intervention trials, only about 100 (~2%) are focused on medications for substance use disorders.
2 Ibid.
3 Ibid.
4 ASAM staff analysis, supported by Copilot review, of NIH ClinicalTrials.gov data indicating that approximately 73% of all active U.S. medication‑intervention trials have advanced to phase 2 or later, a substantially higher proportion than observed among SUD‑focused medication trials.
5 ASAM staff analysis, supported by Copilot review, of NIH ClinicalTrials.gov data.
6 Ibid.
7 Ibid.
8 Substance Abuse and Mental Health Services Administration. (2024). National Survey on Drug Use and Health (NSDUH), 2024: National findings. U.S. Department of Health and Human Services. https://www.samhsa.gov/data/
9 NIDA and NIAAA are funded at a combined level of ~$2.3 billion out of the total $47.2 billion NIH budget (~5%).
10 Consolidated Appropriations Act, 2026, Pub. L. No. 119-75, H.R. 7148, 119th Cong. (2026). https://www.congress.gov/bill/119th-congress/house-bill/7148