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New treatment option for Alcohol Use Disorder
Official title Anxiety During Abstinence in AUD
ClinicalTrials.gov ID: NCT06793488
What this study is testing
What is Disulfiram 250 mg?
Disulfiram 250 mg is an investigational medicine, being studied as a potential treatment for alcohol use disorder.
Also referred to as antabuse.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 55. Healthy volunteers may be eligible.
You may be able to join if
- (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
You likely can't join if
- (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...
- 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
See the full eligibility 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) (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.
- (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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.