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Anti-alcoholism Medication

All participants for Fundus Flavimaculatus

Phase 1

Waitlist Available

Research Sponsored by University of Rochester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 180

Awards & highlights

Study Summary

This trial aims to see if a drug called disulfiram, commonly known as Antabuse, can improve vision in patients with retinal degeneration who also have an alcohol use disorder. The drug

Who is the study for?

This trial is for patients with various types of retinal degeneration, such as Stargardt Disease and Age-Related Macular Degeneration. Participants must also be receiving disulfiram for alcohol use disorder management. Specific inclusion and exclusion criteria details are not provided.Check my eligibility

What is being tested?

The study is testing the effects of oral disulfiram (Antabuse®) on improving vision in patients with retinal degeneration. It's based on findings that it may reduce hyperactivity in the retina by decreasing Retinoic Acid synthesis.See study design

What are the potential side effects?

While specific side effects related to this trial aren't listed, common side effects of disulfiram can include drowsiness, headache, metallic taste, skin rash, and in some cases more severe reactions like liver problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 180

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 180

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 180 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

mean change in Best Corrected Visual Acuity (BCVA) score assessed by ETDRS

Secondary outcome measures

mean change in National Eye Institute-Visual Functioning Questionnaire 25 composite score.

mean change in cone and rod amplitude assessed using Full field electroretinogram (ffERG)

mean change in cone and rod amplitude assessed using multifocal electroretinogram (mfERG)

+10 more

Side effects data

From 2012 Phase 4 trial • 41 Patients • NCT00721526

30%

Alcohol intolerance

Pain

Arthralgia

Transaminases increased

Insomnia

Myalgia

Apathy

Abdominal pain

Headache

Back pain

Muscle spasms

Micturition urgency

Tinnitus

Epistaxis

Flatulence

Chest pain

Dyspnoea

Hyperhidrosis

Pollakiuria

Nausea

Panic attack

Pruritus

Dyspepsia

Feelings of worthlessness

Hallucination

Tooth abscess

Weight decreased

Decreased appetite

Bunion operation

Metrorrhagia

Candida infection

Asthenia

Concussion

Fatigue

Temporomandibular joint syndrome

Confusional state

100%

80%

60%

40%

20%

Study treatment Arm

Disulfiram Plus Lorazepam

Trial Design

1Treatment groups

Experimental Treatment

Group I: All participantsExperimental Treatment1 Intervention

Participants will receive either drug or placebo for 180 days.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor

838 Previous Clinical Trials

518,557 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are they currently enrolling participants for this investigation?

"According to information from clinicaltrials.gov, this specific study is not presently enrolling new participants. Despite being listed on 4/15/2024 and last updated on 3/18/2024, it is inactive for recruitment currently. It's worth noting that out of the total trials listed, there are currently 511 other active studies seeking participants."

Answered by AI

Have all participants in the study been reviewed and approved by the FDA?

"Given the limited supporting data for safety and effectiveness in this Phase 1 trial, our team at Power rates participant safety as a level 1 on the scale of assessment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Effects of Disulfiram (Antabuse®) on Visual Acuity in Patients With Retinal Degeneration

Alex Levin 2024. "The Effects of Disulfiram (Antabuse®) on Visual Acuity in Patients With Retinal Degeneration". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06319872.