NCT06793488 · Columbia University
Anxiety During Abstinence in AUD
What this study is about
The goal of this study is to better understand the underlying neurobiological basis of anxiety that emerges during abstinence in patients with alcohol use disorder (AUD). The main questions it aims to answer are: 1. To characterize anxiety itself as well as anxiety related-neurobiological circuitry in early abstinence in AUD 2.
View original scientific description
The goal of this study is to better understand the underlying neurobiological basis of anxiety that emerges during abstinence in patients with alcohol use disorder (AUD). The main questions it aims to answer are: 1. To characterize anxiety itself as well as anxiety related-neurobiological circuitry in early abstinence in AUD 2. To examine how anxiety and anxiety related-neurobiological circuitry change over the course of abstinence in AUD Researchers will recruit both participants with AUD and healthy volunteers. The participants with AUD will be prescribed disulfiram, a medication that helps participants with AUD stay abstinent. Healthy volunteers will not receive antabuse. Patients with AUD will undergo fMRI scanning both after 1 week and 3 months of disulfiram treatment. Healthy volunteers will undergo fMRI once.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- (Participants with Alcohol use Disorder):
- Between the ages of 21 and 55
- Right-handed
- Able to perform informed consent and comply with study
- Seeking treatment for AUD
- Meets The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for AUD of at least moderate severity (\>3 symptoms) Inclusion Criteria (Healthy Volunteer Participants):
- Between the ages of 21 and 55
- Right-handed
- Able to perform informed consent and comply with study
- Report drinking an average of fewer than 8/15 standard drinks per week for women/men and no more than 1 HDD (heavy drinking days) during the previous 28 days.
Exclusion criteria
- (Participants with Alcohol use Disorder):
- Neurological, medical or other conditions that would interfere with MRI scanning (e.g., history of stroke, seizure, brain tumor, brain infection, traumatic brain injury, multiple sclerosis, dementia, non MRI-compliant metal device in body, pregnancy, claustrophobia, color blindness, severe hearing impairment, weight\>300 lbs., wheelchair-bound, tattoos as indicated by the guidelines established by the Zuckerman Institute MRI unit: https://mr.research.columbia.edu/
- DSM 5 diagnoses of schizophrenia, schizoaffective disorder, or bipolar disorder
- Any non-AUD psychiatric disorder that may, according to the investigator's judgment, require treatment over the course of the study
- Significant suicide or violence risk
- Currently taking psychotropic medication
- Current substance use disorder other than AUD, tobacco use disorder or mild cannabis use disorder
- Currently pregnant, attempting to become pregnant or nursing
- Sufficiently socially unstable as to preclude participation (e.g. homeless).
- Known history of allergy, intolerance, or hypersensitivity to disulfiram or its derivates
- Contraindications to disulfiram treatment (e.g. liver disease, kidney disease, cardiac disease, seizure disorder, hypothyroidism, diabetes mellitus, pregnancy or lactation, allergy to disulfiram or thiuram derivatives)
- Currently taking medications containing alcohol, metronidazole, isoniazid, paraldehyde, phenytoin, warfarin, or theophylline.
- Treatment with concomitant medications that might interfere with disulfiram
- A history of alcohol withdrawal seizures, delirium tremens or resistant alcohol withdrawal
- Current moderate or severe alcohol withdrawal (CIWA \>9 with BAL\<0.05)
- History of prior disulfiram treatment failure
- Being abstinent for \> 7 days at the time of screening Exclusion Criteria (Healthy Volunteer Participants):
- Neurological, medical or other conditions that would interfere with MRI scanning (e.g., history of stroke, seizure, brain tumor, brain infection, traumatic brain injury, multiple sclerosis, dementia, non MRI-compliant metal device in body, pregnancy, claustrophobia, color blindness, severe hearing impairment, weight\>300 lbs., wheelchair- bound, tattoos as indicated by the guidelines established by the ZI MRI unit: https://mr.research.columbia.edu/
- DSM 5 diagnoses of schizophrenia, schizoaffective disorder, or bipolar disorder
- Any psychiatric disorder that may, according to the investigator's judgment, require treatment over the course of the study
- Significant suicide or violence risk
- Currently taking psychotropic medication
- Current substance use disorder other than tobacco use disorder or mild cannabis use disorder
- Currently pregnant, attempting to become pregnant or nursing
- Sufficiently socially unstable as to preclude participation (e.g., homeless).
- A diagnosis of AUD of any severity
Where
- New York, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 10, 2026 · Source of record for eligibility and locations