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New treatment option for Alcohol Use Disorder
Official title The Effects of Disulfiram (Antabuse®) on Visual Acuity in Patients With Retinal Degeneration
ClinicalTrials.gov ID: NCT06319872
What this study is testing
What is Oral disulfiram?
Oral disulfiram is an investigational medicine, given as a pill taken by mouth, 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
- Oral disulfiram (Antabuse®) has been shown to improve image-forming vision in animal models with retinal degeneration due to its ability to decrease Retinoic Acid synthesis and consequently reduce hyperactivity in the inner retina. The investigator will aim to evaluate the impact of oral disulfiram on the vision of patients with retinal degeneration who are being treated with the drug in the management of their concurrent alcohol use disorder.
- 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 18 and older
You may be able to join if
- All sexes, 18 years and older.
- Participants must speak English, understand, and sign the informed consent document.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- In good general health as evidenced by medical history and with a clinical diagnosis of inherited retinal dystrophy or dry-AMD.
- Best Corrected Visual Acuity (BCVA) of 20/20 (with constriction or other defects of Goldmann visual field) to Light Perception in the better eye.
You likely can't join if
- A condition that, in the opinion of the investigator, would preclude participation in the study, e.g., cardiovascular disease, hepatitis.
- Individuals with a history of diabetes mellitus.
- Individuals with a history of psychosis.
- Individuals with hypothyroidism.
- Individuals with hypersensitivity to thiuram derivatives causing rubber contact dermatitis.
- Those on anticoagulant therapy or other medications that may be affected by disulfiram.
See the full eligibility criteria
- All sexes, 18 years and older.
- Participants must speak English, understand, and sign the informed consent document.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- In good general health as evidenced by medical history and with a clinical diagnosis of inherited retinal dystrophy or dry-AMD.
- Best Corrected Visual Acuity (BCVA) of 20/20 (with constriction or other defects of Goldmann visual field) to Light Perception in the better eye.
- Intact inner nuclear layer, inner plexiform, and ganglion cell layer on macular SD-OCT.
- Ability to take oral medication and be willing to adhere to the disulfiram regimen.
- Patients must have the diagnosis of alcohol use disorder provided by an addiction specialist and be a candidate for therapeutic use of disulfiram for that condition.
- Patients must agree to refrain from all alcohol consumption for 180 days.
- Any female participant of childbearing potential must have a negative urine pregnancy test at screening.
- Any female participant of childbearing potential must have (or have a partner who has) had a surgical sterilization (vasectomy, hysterectomy, or tubal ligation), be completely abstinent from intercourse or must agree to...
- A condition that, in the opinion of the investigator, would preclude participation in the study, e.g., cardiovascular disease, hepatitis.
- Individuals with a history of diabetes mellitus.
- Individuals with a history of psychosis.
- Individuals with hypothyroidism.
- Individuals with hypersensitivity to thiuram derivatives causing rubber contact dermatitis.
- Those on anticoagulant therapy or other medications that may be affected by disulfiram.
- Ophthalmic conditions with independent effect upon visual function (e.g. diabetic retinopathy, glaucoma, cataract, vitreous hemorrhage, retinal detachment, active intraocular inflammation or active infectious ocular...
- Patients with No Light Perception (NLP) in both eyes.
- History of major ocular surgery within the prior 6 months or major ocular surgery anticipated within the next 6 months following randomization.
- Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis
- Participation in an investigational trial that involves treatment with any drug within 30 days of randomization that has not received regulatory approval at the time of study entry. Note: study participants cannot...
- Known allergy or hypersensitivity to any component of the study drug.
- For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months.
- Participants who expect to move out of the area of the clinical center during the 8 months of the study
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, 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.