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35th AM (2025) - Poster Session
Clinical Trials for Cocaine Use Disorder Registere ...
Clinical Trials for Cocaine Use Disorder Registered on Global Databases
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Pdf Summary
This review identified 38 clinical trials investigating treatments for Cocaine Use Disorder (CUD), predominantly conducted in the United States (n=32), with additional studies in the Netherlands (n=5) and Australia (n=1). No ongoing trials were found in Canadian, Iranian, or Swiss registries. The research encompassed three novel pharmacologic interventions not yet FDA-approved: psilocybin (a hallucinogen), the gene viral vector AAV8-hCocH, and the dAd5GNE vaccine (an anti-cocaine vaccine).<br /><br />Device-based therapies were also explored, including transcranial magnetic stimulation (TMS), repetitive TMS (rTMS), deep brain stimulation (DBS), and Low-Intensity Focused Ultrasound (LIFU). Behavioral interventions remained prevalent, featuring cognitive behavioral therapy (CBT), contingency management (CM), and emerging cognitive approaches such as Episodic Future Thinking (EFT), Control Episodic Thinking (CET), Working Memory Training (WMT), and Computerized Chemosensory-Based Orbitofrontal Networks Training (CBOT). Notably, several trials implemented internet-based formats of CBT and CM, signifying an increasing emphasis on digital therapeutics.<br /><br />Trial characteristics showed an average follow-up period of three months (range 0.75 to 24 months) and a mean sample size of 68 participants (range 8 to 600). Most trials (94.7%) used randomized designs, and about one-third (31.6%) were unmasked. Around 55% of trials adhered to FDA guidelines regarding combined outcomes and follow-up durations of at least three months.<br /><br />While many studies focus on repurposing existing therapies, the advent of innovative treatments such as gene therapy and anti-cocaine vaccines presents promising prospects for more effective and enduring solutions. The authors emphasize that ongoing collaboration among researchers, regulatory bodies, and industry will be essential to accelerate the development of novel, efficacious treatments for CUD, thereby improving patient outcomes and addressing this critical public health issue.
Keywords
Cocaine Use Disorder
clinical trials
pharmacologic interventions
psilocybin
gene therapy
anti-cocaine vaccine
device-based therapies
behavioral interventions
digital therapeutics
randomized controlled trials
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