NCT06319872 The Effects of Disulfiram (Antabuse®) on Visual Acuity in Patients With Retinal Degeneration
| NCT ID | NCT06319872 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Rochester |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-05-19 |
| Primary Completion | 2029-05-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2025-05-19 with a primary completion date of 2029-05-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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 practice two acceptable methods of contraception throughout the course of the study and for at least one week after disulfiram discontinuation. Acceptable methods of contraception include hormonal contraception (i.e., birth control pills, injected hormones, dermal patch, or vaginal ring); intrauterine device; barrier methods (diaphragm, condom) with spermicide. Exclusion Criteria: * 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 diseases, choroidal neovascularization). * 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 receive another investigational drug while participating in this study. * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06319872 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06319872 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06319872 currently recruiting?
Yes, NCT06319872 is actively recruiting participants. Contact the research team at evan_burr@urmc.rochester.edu for enrollment information.
Where is the NCT06319872 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT06319872 clinical trial?
NCT06319872 is sponsored by University of Rochester. The trial plans to enroll 15 participants.