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NCT Number: NCT06793488

Anxiety During Abstinence in AUD

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.

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Key information

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Columbia University Irving Medical Center

New York, 10019, United States

Location status: Recruiting

Location contact

A B Srivastava, MD

CONTACT

[email protected]

646-774-8189

About this study

This study will recruit 40 treatment-seeking participants with AUD ("AUDP") and 20 age matched healthy volunteer participants (HVP). AUDP will be initiated on disulfiram, a medication FDA approved for alcohol use disorder that is a first line treatment for maintenance of abstinence from alcohol, to facilitate and help ensure abstinence from alcohol and will undergo functional MRI scanning at two timepoints: 1) 8-14 days after the last drink ("early abstinence") and 2) after three months of abstinence ("protracted abstinence"). HVP will be scanned once. The investigators will examine the functioning of the Anterior Insula (AI), Bed Nucleus of the Stria Terminalis (BNST), and Dorsolateral Prefrontal Cortex (DLPFC) during a task that evokes anxiety while anticipating an uncertain threat ("threat-anxiety") as well as resting state functional connectivity (RSFC) between AI-BNST and AI-DLPFC to measure whether there are neuroplastic changes in these circuits that occur during abstinence. These changes in anxiety circuit activity and connectivity will be related to changes in current anxiety symptoms.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Disulfiram 250 mg

Drug

Disulfiram will be used in Participants with Alcohol Use Disorder only to facilitate abstinence.

Other names: antabuse

Functional MRI

Diagnostic Test

Participants will undergo fMRI scanning. Participants with alcohol use disorder will undergo scanning after 1 week and 3 months of disulfiram maintenance. Healthy volunteer participants will undergo scanning once.

Other names: fMRI

Primary outcomes

  1. AI-BNST Resting state functional connectivity correlation (R) value

    Time frame: 1 week and 3 months

    Resting state functional connectivity between the bed nucleus of the stria terminalis and anterior insula resting state functional connectivity. Correlation values range from -1 to +1, with higher values indicating stronger connectivity.

  2. AI-BNST task activation t statistic

    Time frame: 1 week and 3 months

    Unpredictable threat task activation of the bed nucleus of the stria terminalis and anterior insula. T statistics range from negative infinity to positive infinity. The farther the t statistic is away from zero (positively), this indicates a larger magnitude in brain activation

  3. State trait anxiety inventory score

    Time frame: 1 week and 3 months

    The State-Trait Anxiety Inventory (STAI) score ranges from 20-80, with higher scores indicating greater anxiety

Study contacts

Contact information is provided by the study sponsor or research team.

A B Srivastava, MD

CONTACT

[email protected]

646-774-8189

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Neural Mechanisms of Anxiety During Early and Protracted Abstinence in Alcohol Use Disorder

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jan 27, 2025
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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