Early phase 1: continuous Theta Burst Stimulation (cTBS) for Normal Physiology
Background: People with substance use disorder (SUD) often have changes in brain function that can make it difficult to control drug-seeking behavior. These changes may heighten the urge to use drugs or lessen the desire to seek nondrug-related rewards.
Official registry: https://clinicaltrials.gov/study/NCT06561828 · National Institute on Drug Abuse (NIDA) · enrollment listed as 600
What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are continuous Theta Burst Stimulation (cTBS), intermittent Theta Burst Stimulation (iTBS), or sham Theta Burst Stimulation (sham TBS). The registry lists allocation as randomized. Background: People with substance use disorder (SUD) often have changes in brain function that can make it difficult to control drug-seeking behavior.
They plan to enroll about 600 people at Baltimore. Taking part typically means using or being fitted with a device plus check-ins.
Official title (unrewritten)
Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making
Interventions: continuous Theta Burst Stimulation (cTBS), intermittent Theta Burst Stimulation (iTBS), sham Theta Burst Stimulation (sham TBS)
Primary outcome (registry wording): Task Performance
Who it is for (from inclusion criteria)
- Ages 18 Years to 45 Years
- In order to be eligible to participate in this study, an individual must meet the following criteria:
- Aged 18-45 years old. Justification: Many neural processes change with age, and these changes could introduce unwanted variability in the measured signals
- In good general health based on the assessment of the MAI
Who the registry excludes
- Individuals who meet any of the following criteria will be excluded from participation:
- Predisposition to seizures (e.g., first-degree family history of potentially hereditary epilepsy, etc.)
- Unable to undergo MRI or TMS due to certain metallic or magnetic devices or implants in the body, claustrophobia, or other reasons
- History of noise-induced hearing loss or tinnitus
- Recent history (within past 12 months) of learning disability, major DSM-5 psychiatric disorder including major affective disorder, ADHD, obsessive-compulsive disorder, schizophrenia, or PTSD. This will be determined at the discretion of the MAI
- Pattern of alcohol and drug use in the past 12 months that is indicative of harmful use, loss of control over use, or physical dependence
- Daily nicotine, alcohol, or drug use (excluding caffeine) for at least 4 continuous weeks within the past 12 months
Public study contact (from the registry)
NIDA IRP Screening Team
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- National Institute on Drug Abuse — Baltimore, Maryland (recruiting)
FAQ about this NCT record
Is NCT06561828 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06561828?
Early phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06561828?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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