On October 5, 2025, NYU Langone Health and the National Institute on Drug Abuse (NIDA) announced a significant step forward in addressing Cannabis Use Disorder. A new clinical trial combining advanced transcranial direct current stimulation (tDCS) technology and mindfulness meditation seeks to provide alternative treatment options for patients struggling with cannabis dependency. While recruitment for the trial has not yet begun, its promising methodology already has the attention of clinical, quality, and regulatory professionals.
In this article:
- What changed?
- Trial details and key interventions
- Who is eligible for the trial?
- FAQs
- Conclusion and insights
- Disclaimer
- Announcement link
What changed?
The announcement introduces a groundbreaking research initiative known as the “C.A.R.E.S. Initiative,” focusing on Cannabis Use Disorder, which has become a growing concern in public health. This study stands out for integrating tDCS, a medical device intervention, with behavioral mindfulness practices. Researchers aim to explore whether this combination can improve patient outcomes, targeting both the neurological and psychological aspects of the disorder.
The trial is currently listed as “Not yet recruiting” on ClinicalTrials.gov, meaning patient enrollment has not started. Clinical, quality, and regulatory teams are now keeping a close watch on the development, potentially influencing device performance expectations and behavioral therapy guidelines.
Trial details and key interventions
What is tDCS?
Transcranial Direct Current Stimulation (tDCS) involves the use of low electrical currents delivered through electrodes positioned on the scalp. This non-invasive technology is designed to modulate brain activity, particularly in regions connected to addiction behavior. In the C.A.R.E.S. Initiative, active tDCS will be utilized alongside a sham device to benchmark efficacy.
Mindfulness integration
Mindfulness meditation, a behavioral intervention employed in this trial, has been widely studied for its role in combatting cravings and promoting mental wellness. This research seeks to determine if mindfulness techniques, paired with tDCS, offer synergistic benefits for treating Cannabis Use Disorder.
Principal sponsors
NYU Langone Health and the National Institute on Drug Abuse (NIDA) are the driving forces behind this study. NIDA’s involvement underscores the importance of innovation in addiction treatment, aligning with its mission to advance research in effective behavioral and medical therapies.
Who is eligible for the trial?
While specific inclusion and exclusion criteria remain unpublished at this stage, it is anticipated that the trial will focus on individuals diagnosed with Cannabis Use Disorder. Participants will likely undergo a thorough screening process to ensure suitability for both medical device exposure and behavioral interventions.
Recruitment timelines have not yet been disclosed, but interested parties are advised to keep an eye on regulatory updates. Professionals seeking eligibility details or patient referral frameworks will find updates hosted on ClinicalTrials.gov.
FAQs
1. What is the current status of this clinical trial?
The trial is labeled as “Not yet recruiting,” meaning patient enrollment has not begun.
2. Who are the sponsors?
NYU Langone Health and NIDA (National Institute on Drug Abuse) are sponsoring the study.
3. How will mindfulness meditation be incorporated?
Mindfulness practices will be combined with active and sham tDCS sessions to evaluate their combined effect on cannabis dependency.
4. Where can I find regular updates?
Ensure periodic reviews of updates at ClinicalTrials.gov at the provided link.
Conclusion and insights
The C.A.R.E.S. Initiative represents an innovative approach to treating Cannabis Use Disorder, leveraging advances in medical device technology and behavioral therapy. For regulatory and clinical teams, this trial may provide valuable insights into combined treatment modalities and new standards for device application in addiction therapy.
Professionals are encouraged to monitor developments closely as recruitment begins and findings unfold. With NYU Langone Health and NIDA collaborating on this groundbreaking project, it could set a new benchmark in the addiction treatment landscape.
Disclaimer
The information provided here is intended for general professional purposes and is not legal advice. For specific regulatory concerns, consult appropriate legal, medical, or policy experts.
Announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07184983?term=medical+device