Status:
RECRUITING
Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Normal Physiology
Eligibility:
All Genders
18-45 years
Phase:
EARLY_PHASE1
Brief Summary
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...
Detailed Description
Study Description: Learning and decision-making are critical for adaptive behavior and survival. Treating maladaptive behaviors in neuropsychiatric conditions, such substance use disorder, requires k...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- In order to be eligible to participate in this study, an individual must meet the following criteria:
- Willingness to comply with all study procedures and availability for the duration of the study. Consent signature will be documentation of meeting this criterion.
- 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.
- Agreement to adhere to Lifestyle Considerations throughout study
- duration. Consent signature will be documentation of meeting this criterion.
- Right-handed.
- EXCLUSION CRITERIA:
- Individuals who meet any of the following criteria will be excluded from participation:
- Any neurological disorder that would increase seizure risk from TMS such as stroke, brain lesions, previous neurosurgery, epilepsy, any history of seizure or fainting episode of unknown cause, frequent severe headache, or head trauma resulting in loss of consciousness, lasting over 30 minutes or with sequela lasting longer than one month. The MAI will also retain discretion to exclude based on a history of a neurological illness or trauma that may compromise safety or data integrity.
- Predisposition to seizures (e.g., first-degree family history of potentially hereditary epilepsy, etc.).
- Current use (any use in the past two weeks, daily use for more than one week within past 3 months) of any investigational drug or of any medications with psychotropic (e.g., benzodiazepines, etc.), anti or pro-convulsive action. This will be determined at the discretion of the MAI.
- 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.
- Participation in any neuromodulation (e.g., TMS, tFUS, tDCS, tACS, etc.) session (excluding the current protocol) in the past two weeks.
- For tasks that involve gustatory or olfactory stimuli, food intake: History of anaphylaxis, e.g., due to severe asthma or food and non-food allergies (e.g., latex, detergents, soap, etc.). This will disqualify participants for tasks that involve chemosensory stimuli or food intake, but not from the protocol itself.
- Uncorrected impairments in visual acuity severe enough to affect task participation.
- Non-English speaking. Justification: Data integrity of some of the cognitive tasks used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing TMS and MRI procedures. The inability to effectively communicate TMS and MRI safety procedures in a language other than English could compromise the safety of non-English speaking participants.
- Pregnancy. Justification: It is unknown whether MRI and TMS pose risks to fetuses.
- Any other condition that in the judgment of the investigators is incompatible with participation.
Exclusion
Key Trial Info
Start Date :
January 14 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 2 2044
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06561828
Start Date
January 14 2026
End Date
November 2 2044
Last Update
January 9 2026
Active Locations (1)
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1
National Institute on Drug Abuse
Baltimore, Maryland, United States, 21224