Early Phase 1 Depression and Anxiety Trial, Recruiting NCT06793488 Sponsor: Columbia University Condition: Depression and Anxiety
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Early Phase 1 Depression and Anxiety Trial, Recruiting

NCT06793488
Recruiting Early Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

For people with alcohol use disorder (AUD):

  • People aged between 21 and 55 years old
  • People who are right-handed
  • People who are able to give informed consent and follow the study requirements
  • People who are actively looking for treatment for alcohol use disorder
  • People who have been diagnosed with moderate or severe alcohol use disorder (more than 3 symptoms according to standard diagnostic criteria)

For healthy volunteers (people without alcohol use disorder):

  • People aged between 21 and 55 years old
  • People who are right-handed
  • People who are able to give informed consent and follow the study requirements
  • People who drink, on average, fewer than 8 standard drinks per week (for women) or fewer than 15 standard drinks per week (for men), and have had no more than one heavy drinking day in the past 28 days

Who may not be able to join:

For people with alcohol use disorder:

  • People with certain neurological or medical conditions, or other factors that could interfere with MRI scanning — such as a history of stroke, seizure, brain tumour, brain infection, traumatic brain injury, multiple sclerosis, or dementia; having a non-MRI-safe metal device in the body; pregnancy; claustrophobia; colour blindness; severe hearing impairment; weighing more than 300 lbs; being wheelchair-bound; or having tattoos that do not meet the guidelines set by the trial's MRI facility (confirm with trial site)
  • People who have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder
  • People who have any other psychiatric condition that, in the investigator's judgment, would require treatment during the study period
  • People considered to have a significant risk of suicide or violence
  • People who are currently taking any psychiatric medications
  • People who currently have a substance use disorder other than alcohol use disorder, tobacco use disorder, or mild cannabis use disorder
  • People who are currently pregnant, trying to become pregnant, or breastfeeding
  • People whose living situation is so unstable (for example, homelessness) that participation would not be possible
  • People with a known allergy, intolerance, or sensitivity to the study drug disulfiram or related substances
  • People with medical conditions that make treatment with disulfiram unsafe — such as liver disease, kidney disease, heart disease, seizure disorder, underactive thyroid, or diabetes
  • People currently taking medications that contain alcohol, or certain other medications including metronidazole, isoniazid, paraldehyde, phenytoin, warfarin, or theophylline
  • People taking other medications that may interfere with disulfiram (confirm with trial site)
  • People with a history of severe alcohol withdrawal seizures, a condition called delirium tremens, or difficult-to-treat alcohol withdrawal
  • People currently experiencing moderate or severe alcohol withdrawal symptoms (confirm with trial site)
  • People who have previously tried disulfiram and it did not work for them
  • People who have already been abstinent from alcohol for more than 7 days at the time of screening

For healthy volunteers:

  • People with certain neurological or medical conditions, or other factors that could interfere with MRI scanning — such as those listed above for the AUD group (confirm with trial site)
  • People who have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder
  • People who have any psychiatric condition that, in the investigator's judgment, would require treatment during the study period
  • People considered to have a significant risk of suicide or violence
  • People who are currently taking any psychiatric medications
  • People who currently have any substance use disorder, other than tobacco use disorder or mild cannabis use disorder
  • People who are currently pregnant, trying to become pregnant, or breastfeeding
  • People whose living situation is so unstable (for example, homelessness) that participation would not be possible
  • People who have a diagnosis of alcohol use disorder of any severity

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Phone: 646-774-8189

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Early Phase 1
Registry
ClinicalTrials.gov
Start date
15 September 2025
Est. completion
30 August 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

AI-BNST Resting state functional connectivity correlation (R) value; AI-BNST task activation t statistic; State trait anxiety inventory score

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov