Alcohol Use DisorderEarly Phase 1NCT06793488
Anxiety During Abstinence in AUD
A Early Phase 1 study testing Disulfiram 250 mg and functional MRI in people with Alcohol Use Disorder, run by Columbia University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Disulfiram 250 mg and functional MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2025to 30 Aug 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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/
Show all 21Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10019
A B Srivastava, MD, 646-774-8189, abs2257@cumc.columbia.edu
About this study
Official title: Neural Mechanisms of Anxiety During Early and Protracted Abstinence in Alcohol Use Disorder
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:
- To characterize anxiety itself as well as anxiety related-neurobiological circuitry in early abstinence in AUD
- To examine how anxiety and anxiety related-neurobiological circuitry change over the course of abstinence in AUD
Read more
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.
Read the detailed description
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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Disulfiram 250 mg, functional MRI
- Keywords
- fMRI, disulfiram, withdrawal, anxiety, abstinence
- Medical subject headings
- Alcoholism, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disulfiram 250 mgDrug
Also called antabuse
Disulfiram will be used in Participants with Alcohol Use Disorder only to facilitate abstinence.
functional MRIDiagnostic test
Also called fMRI
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Alcohol Use Disorder | Experimental | Participants with Alcohol Use Disorder (AUDP) will be participants (n=40) ages 21-55 with alcohol use disorder (AUD) who are seeking treatment for AUD. They will undergo 3 months of treatment with disulfiram 250mg daily with supervised dosing and undergo fMRI scanning after 1 week and 3 months of disulfiram treatment. Receives: Drug: Disulfiram 250 mg; Diagnostic Test: functional MRI |
| Healthy volunteer participants | Other | Healthy volunteer participants will be participants (n=20) ages 21-55 without a history of alcohol or other substance use disorders. They will undergo fMRI scanning once. Receives: Diagnostic Test: functional MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
AI-BNST Resting state functional connectivity correlation (R) value
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.
Measured: 1 week and 3 months
AI-BNST task activation t statistic
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
Measured: 1 week and 3 months
State trait anxiety inventory score
The State-Trait Anxiety Inventory (STAI) score ranges from 20-80, with higher scores indicating greater anxiety
Measured: 1 week and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start15 Sep 2025
- Primary completion30 Aug 2029 (estimated)
- Study completion30 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants with alcohol use disorder (n=40) will be administered disulfiram for 3 months, which will serve to facilitate abstinence from alcohol in order to study the mechanisms of anxiety during early and protracted abstinence in alcohol use disorder. The will undergo fMRI scanning after 1 week and 3 months of disulfiram. Participants will be observed taking disulfiram both remotely (4/5 work days/week) and in person 1 day/week. Healthy volunteer participants (n=20) will not receive disufiram and will only be scanned once.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, A. Benjamin Srivastava, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793488
- Sponsor's protocol ID
- AAAV4012
- Other IDs
- K23AA030355
- Status last verified
- Feb 2026
- First submitted
- 21 Jan 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: fMRI data and metadata will be archived in OpenNeuro, and Electrodermal Activity data will be stored in the DANDI archive and deposited to NIAAA Data Archive (NIAAADA), which is part of the NIMH NDA. All data will be de-identified prior to receipt by the repository, but the information needed to generate a global unique identifier for the NIAAADA, which is part of the NIMH NDA, will be collected for each subject. Sufficient data from this project will be preserved to enable sharing via NIAAADA data of sufficient quality to validate and replicate research findings. NIAAA requires data measured from human subjects to be shared using the NIAAADA. All fMRI resting state and task related paradigm designs and experiment definitions will be deposited in the NIAAADA. Studies will be created that contain the data used for every publication. Sufficient data from this project will be preserved to enable sharing via NDA data of sufficient quality to validate and replicate research findings.
Publications
Anker JJ, Kushner MG, Thuras P, Menk J, Unruh AS. Drinking to cope with negative emotions moderates alcohol use disorder treatment response in patients with co-occurring anxiety disorder. Drug Alcohol Depend. 2016 Feb 1;159:93-100. doi: 10.1016/j.drugalcdep.2015.11.031. Epub 2015 Dec 11.
PubMed 26718394Anker JJ, Kushner MG. Co-Occurring Alcohol Use Disorder and Anxiety: Bridging Psychiatric, Psychological, and Neurobiological Perspectives. Alcohol Res. 2019 Dec 30;40(1):arcr.v40.1.03. doi: 10.35946/arcr.v40.1.03. eCollection 2019.
PubMed 31886106Glasser MF, Coalson TS, Robinson EC, Hacker CD, Harwell J, Yacoub E, Ugurbil K, Andersson J, Beckmann CF, Jenkinson M, Smith SM, Van Essen DC. A multi-modal parcellation of human cerebral cortex. Nature. 2016 Aug 11;536(7615):171-178. doi: 10.1038/nature18933. Epub 2016 Jul 20.
PubMed 27437579Brown SA, Irwin M, Schuckit MA. Changes in anxiety among abstinent male alcoholics. J Stud Alcohol. 1991 Jan;52(1):55-61. doi: 10.15288/jsa.1991.52.55.
PubMed 1994124Centanni SW, Morris BD, Luchsinger JR, Bedse G, Fetterly TL, Patel S, Winder DG. Endocannabinoid control of the insular-bed nucleus of the stria terminalis circuit regulates negative affective behavior associated with alcohol abstinence. Neuropsychopharmacology. 2019 Feb;44(3):526-537. doi: 10.1038/s41386-018-0257-8. Epub 2018 Nov 2.
PubMed 30390064Clauss JA, Avery SN, Benningfield MM, Blackford JU. Social anxiety is associated with BNST response to unpredictability. Depress Anxiety. 2019 Aug;36(8):666-675. doi: 10.1002/da.22891. Epub 2019 Apr 6.
PubMed 30953446Agarwal R, Sharma SK, Malaviya AN. Gold-induced hypersensitivity pneumonitis in a patient with rheumatoid arthritis. Clin Exp Rheumatol. 1989 Jan-Feb;7(1):89-90.
PubMed 2706825Driessen M, Meier S, Hill A, Wetterling T, Lange W, Junghanns K. The course of anxiety, depression and drinking behaviours after completed detoxification in alcoholics with and without comorbid anxiety and depressive disorders. Alcohol Alcohol. 2001 May-Jun;36(3):249-55. doi: 10.1093/alcalc/36.3.249.
PubMed 11373263Farb NA, Segal ZV, Anderson AK. Attentional modulation of primary interoceptive and exteroceptive cortices. Cereb Cortex. 2013 Jan;23(1):114-26. doi: 10.1093/cercor/bhr385. Epub 2012 Jan 19.
PubMed 22267308Flook EA, Feola B, Avery SN, Winder DG, Woodward ND, Heckers S, Blackford JU. BNST-insula structural connectivity in humans. Neuroimage. 2020 Apr 15;210:116555. doi: 10.1016/j.neuroimage.2020.116555. Epub 2020 Jan 16.
PubMed 31954845Joutsa J, Moussawi K, Siddiqi SH, Abdolahi A, Drew W, Cohen AL, Ross TJ, Deshpande HU, Wang HZ, Bruss J, Stein EA, Volkow ND, Grafman JH, van Wijngaarden E, Boes AD, Fox MD. Brain lesions disrupting addiction map to a common human brain circuit. Nat Med. 2022 Jun;28(6):1249-1255. doi: 10.1038/s41591-022-01834-y. Epub 2022 Jun 13.
PubMed 35697842Kushner MG, Abrams K, Thuras P, Hanson KL, Brekke M, Sletten S. Follow-up study of anxiety disorder and alcohol dependence in comorbid alcoholism treatment patients. Alcohol Clin Exp Res. 2005 Aug;29(8):1432-43. doi: 10.1097/01.alc.0000175072.17623.f8.
PubMed 16131851Schuckit MA, Hesselbrock V. Alcohol dependence and anxiety disorders: what is the relationship? Am J Psychiatry. 1994 Dec;151(12):1723-34. doi: 10.1176/ajp.151.12.1723.
PubMed 7977877Schuckit MA, Irwin M, Brown SA. The history of anxiety symptoms among 171 primary alcoholics. J Stud Alcohol. 1990 Jan;51(1):34-41. doi: 10.15288/jsa.1990.51.34.
PubMed 2299847Skinner MD, Lahmek P, Pham H, Aubin HJ. Disulfiram efficacy in the treatment of alcohol dependence: a meta-analysis. PLoS One. 2014 Feb 10;9(2):e87366. doi: 10.1371/journal.pone.0087366. eCollection 2014.
PubMed 24520330
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms of Anxiety During Early and Protracted Abstinence in Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT06793488
- Acronym / sponsor ID
- AAAV4012
- Conditions
- Alcohol Use Disorder
- Keywords
- fMRI, disulfiram, withdrawal, anxiety, abstinence
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 30 Aug 2029 (estimated)
- Study completion
- 30 Aug 2029 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To characterize anxiety itself as well as anxiety related-neurobiological circuitry in early abstinence in AUD
- 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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants with alcohol use disorder (n=40) will be administered disulfiram for 3 months, which will serve to facilitate abstinence from alcohol in order to study the mechanisms of anxiety during early and protracted abstinence in alcohol use disorder. The will undergo fMRI scanning after 1 week and 3 months of disulfiram. Participants will be observed taking disulfiram both remotely (4/5 work days/week) and in person 1 day/week. Healthy volunteer participants (n=20) will not receive disufiram and will only be scanned once.
| Arm | Type | Receives |
|---|---|---|
| Participants with Alcohol Use Disorder | Experimental | Drug: Disulfiram 250 mg, Diagnostic Test: functional MRIParticipants with Alcohol Use Disorder (AUDP) will be participants (n=40) ages 21-55 with alcohol use disorder (AUD) who are seeking treatment for AUD. They will undergo 3 months of treatment with disulfiram 250mg daily with supervised dosing and undergo fMRI scanning after 1 week and 3 months of disulfiram treatment. |
| Healthy volunteer participants | Other | Diagnostic Test: functional MRIHealthy volunteer participants will be participants (n=20) ages 21-55 without a history of alcohol or other substance use disorders. They will undergo fMRI scanning once. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- 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.
- 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/
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disulfiram 250 mgAlso: antabuseDisulfiram will be used in Participants with Alcohol Use Disorder only to facilitate abstinence. | Drug | Participants with Alcohol Use Disorder |
| functional MRIAlso: fMRIParticipants 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. | Diagnostic test | Healthy volunteer participants, Participants with Alcohol Use Disorder |
Primary outcome
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.
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Background: PubMed 26718394Anker JJ, Kushner MG, Thuras P, Menk J, Unruh AS. Drinking to cope with negative emotions moderates alcohol use disorder treatment response in patients with co-occurring anxiety disorder. Drug Alcohol Depend. 2016 Feb 1;159:93-100. doi: 10.1016/j.drugalcdep.2015.11.031. Epub 2015 Dec 11.
- Background: PubMed 31886106Anker JJ, Kushner MG. Co-Occurring Alcohol Use Disorder and Anxiety: Bridging Psychiatric, Psychological, and Neurobiological Perspectives. Alcohol Res. 2019 Dec 30;40(1):arcr.v40.1.03. doi: 10.35946/arcr.v40.1.03. eCollection 2019.
- Background: PubMed 27437579Glasser MF, Coalson TS, Robinson EC, Hacker CD, Harwell J, Yacoub E, Ugurbil K, Andersson J, Beckmann CF, Jenkinson M, Smith SM, Van Essen DC. A multi-modal parcellation of human cerebral cortex. Nature. 2016 Aug 11;536(7615):171-178. doi: 10.1038/nature18933. Epub 2016 Jul 20.
- Background: PubMed 1994124Brown SA, Irwin M, Schuckit MA. Changes in anxiety among abstinent male alcoholics. J Stud Alcohol. 1991 Jan;52(1):55-61. doi: 10.15288/jsa.1991.52.55.
- Background: PubMed 30390064Centanni SW, Morris BD, Luchsinger JR, Bedse G, Fetterly TL, Patel S, Winder DG. Endocannabinoid control of the insular-bed nucleus of the stria terminalis circuit regulates negative affective behavior associated with alcohol abstinence. Neuropsychopharmacology. 2019 Feb;44(3):526-537. doi: 10.1038/s41386-018-0257-8. Epub 2018 Nov 2.
- Background: PubMed 30953446Clauss JA, Avery SN, Benningfield MM, Blackford JU. Social anxiety is associated with BNST response to unpredictability. Depress Anxiety. 2019 Aug;36(8):666-675. doi: 10.1002/da.22891. Epub 2019 Apr 6.
- Background: PubMed 2706825Agarwal R, Sharma SK, Malaviya AN. Gold-induced hypersensitivity pneumonitis in a patient with rheumatoid arthritis. Clin Exp Rheumatol. 1989 Jan-Feb;7(1):89-90.
- Background: PubMed 11373263Driessen M, Meier S, Hill A, Wetterling T, Lange W, Junghanns K. The course of anxiety, depression and drinking behaviours after completed detoxification in alcoholics with and without comorbid anxiety and depressive disorders. Alcohol Alcohol. 2001 May-Jun;36(3):249-55. doi: 10.1093/alcalc/36.3.249.
- Background: PubMed 22267308Farb NA, Segal ZV, Anderson AK. Attentional modulation of primary interoceptive and exteroceptive cortices. Cereb Cortex. 2013 Jan;23(1):114-26. doi: 10.1093/cercor/bhr385. Epub 2012 Jan 19.
- Background: PubMed 31954845Flook EA, Feola B, Avery SN, Winder DG, Woodward ND, Heckers S, Blackford JU. BNST-insula structural connectivity in humans. Neuroimage. 2020 Apr 15;210:116555. doi: 10.1016/j.neuroimage.2020.116555. Epub 2020 Jan 16.
- Background: PubMed 35697842Joutsa J, Moussawi K, Siddiqi SH, Abdolahi A, Drew W, Cohen AL, Ross TJ, Deshpande HU, Wang HZ, Bruss J, Stein EA, Volkow ND, Grafman JH, van Wijngaarden E, Boes AD, Fox MD. Brain lesions disrupting addiction map to a common human brain circuit. Nat Med. 2022 Jun;28(6):1249-1255. doi: 10.1038/s41591-022-01834-y. Epub 2022 Jun 13.
- Background: PubMed 16131851Kushner MG, Abrams K, Thuras P, Hanson KL, Brekke M, Sletten S. Follow-up study of anxiety disorder and alcohol dependence in comorbid alcoholism treatment patients. Alcohol Clin Exp Res. 2005 Aug;29(8):1432-43. doi: 10.1097/01.alc.0000175072.17623.f8.
- Individual participant dataSharing planned: Yes. fMRI data and metadata will be archived in OpenNeuro, and Electrodermal Activity data will be stored in the DANDI archive and deposited to NIAAA Data Archive (NIAAADA), which is part of the NIMH NDA. All data will be de-identified prior to receipt by the repository, but the information needed to generate a global unique identifier for the NIAAADA, which is part of the NIMH NDA, will be collected for each subject. Sufficient data from this project will be preserved to enable sharing via NIAAADA data of sufficient quality to validate and replicate research findings. NIAAA requires data measured from human subjects to be shared using the NIAAADA. All fMRI resting state and task related paradigm designs and experiment definitions will be deposited in the NIAAADA. Studies will be created that contain the data used for every publication. Sufficient data from this project will be preserved to enable sharing via NDA data of sufficient quality to validate and replicate research findings.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Disulfiram 250 mg and functional MRI in people with Alcohol Use Disorder, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact A B Srivastava, MD (646-774-8189, abs2257@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AI-BNST Resting state functional connectivity correlation (R) value (time frame: 1 week and 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06793488, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.