CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 7 enrolled
Drug / intervention
Disulfiramdrug
Likely dose
Disulfiram 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02735577
NCT02735577Phase 4Completed

Neurocognitive Mechanisms of Disulfiram Treatment of Alcohol Use Disorder

New York State Psychiatric Institute·interventional·Posted Apr 12, 2016·Updated Nov 23, 2020

In Brief

A Phase 4 clinical trial evaluating Disulfiram for Alcohol Use Disorder. Completed, enrolled 7 participants across 1 site.

Detailed Summary

This study combines functional MRI with medication treatment in order to understand the neural mechanisms by which disulfiram, a currently approved medication for alcohol use disorder, changes behavior. Disulfiram is a medication that prevents drinking by causing a highly unpleasant physical reaction when alcohol is consumed while it is being taken. Thus, it provides a means for studying the general neural mechanisms by which awareness of risks impacts behavior change in alcohol use disorder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 12, 2016
Enrollment StartMar 1, 2016
Primary CompletionOct 31, 2019
Study CompletionOct 16, 2020
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 10.2 years ago

Interventions

Disulfiramdrug

Patients will be hospitalized on an inpatient psychiatric unit for 1-7 days to initiate abstinence. An fMRI scan will be performed to examine neural mechanisms of alcohol motivation. Prior to discharge, patients will receive the first dose of disulfiram 500 mg. They will then attend an outpatient clinic every other day for 14 days. At each clinic visit, they will receive 500 mg of disulfiram under supervision. Another fMRI scan examining alcohol motivation will be performed. Following this, all patients will attend the clinic weekly, and will be prescribed disulfiram 250 mg daily to take at home. This will be followed followed by an optional extension of weekly visits taking disulfiram 250 mg daily for another 28 days, for a total of 70 days of disulfiram treatment.