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RECRUITINGEarly Phase 1INTERVENTIONAL

Anxiety During Abstinence in AUD

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Inclusion Criteria (Participants with Alcohol use Disorder): 1. Between the ages of 21 and 55 2. Right-handed 3. Able to perform willing to sign a consent form and comply with study 4. Seeking treatment for AUD 5. 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): 1. Between the ages of 21 and 55 2. Right-handed 3. Able to perform willing to sign a consent form and comply with study 4. 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): 1. 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/ 2. DSM 5 diagnoses of schizophrenia, schizoaffective disorder, or bipolar disorder 3. Any non-AUD psychiatric disorder that may, according to the investigator's judgment, require treatment over the course of the study 4. Significant suicide or violence risk 5. Currently taking psychotropic medication 6. Current substance use disorder other than AUD, tobacco use disorder or mild cannabis use disorder 7. Currently pregnant, attempting to become pregnant or nursing 8. Sufficiently socially unstable as to preclude participation (e.g. homeless). 9. Known history of allergy, intolerance, or hypersensitivity to disulfiram or its derivates ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria (Participants with Alcohol use Disorder): 1. Between the ages of 21 and 55 2. Right-handed 3. Able to perform informed consent and comply with study 4. Seeking treatment for AUD 5. 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): 1. Between the ages of 21 and 55 2. Right-handed 3. Able to perform informed consent and comply with study 4. 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): 1. 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/ 2. DSM 5 diagnoses of schizophrenia, schizoaffective disorder, or bipolar disorder 3. Any non-AUD psychiatric disorder that may, according to the investigator's judgment, require treatment over the course of the study 4. Significant suicide or violence risk 5. Currently taking psychotropic medication 6. Current substance use disorder other than AUD, tobacco use disorder or mild cannabis use disorder 7. Currently pregnant, attempting to become pregnant or nursing 8. Sufficiently socially unstable as to preclude participation (e.g. homeless). 9. Known history of allergy, intolerance, or hypersensitivity to disulfiram or its derivates 10. 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) 11. Currently taking medications containing alcohol, metronidazole, isoniazid, paraldehyde, phenytoin, warfarin, or theophylline. 12. Treatment with concomitant medications that might interfere with disulfiram 13. A history of alcohol withdrawal seizures, delirium tremens or resistant alcohol withdrawal 14. Current moderate or severe alcohol withdrawal (CIWA \>9 with BAL\<0.05) 15. History of prior disulfiram treatment failure 16. Being abstinent for \> 7 days at the time of screening Exclusion Criteria (Healthy Volunteer Participants): 1. 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/ 2. DSM 5 diagnoses of schizophrenia, schizoaffective disorder, or bipolar disorder 3. Any psychiatric disorder that may, according to the investigator's judgment, require treatment over the course of the study 4. Significant suicide or violence risk 5. Currently taking psychotropic medication 6. Current substance use disorder other than tobacco use disorder or mild cannabis use disorder 7. Currently pregnant, attempting to become pregnant or nursing 8. Sufficiently socially unstable as to preclude participation (e.g., homeless). 9. A diagnosis of AUD of any severity

Treatments Being Tested

DRUG

Disulfiram 250 mg

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

DIAGNOSTIC_TEST

functional MRI

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.

Locations (1)

Columbia University Irving Medical Center
New York, New York, United States