Trial Outcomes & Findings for Neural Mechanisms of Disulfiram Effects (NCT NCT02735577)

NCT ID: NCT02735577

Last Updated: 2020-11-23

Results Overview

Number of drinking days

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 7 participants
• Primary outcome timeframe: 42 days
• Results posted on: 2020-11-23

Participant Flow

Participant milestones

Measure	Disulfiram Patients in this arm will receive disulfiram 250 mg daily for a total of 42 days. Disulfiram: 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.
Disulfiram Treatment STARTED	7
Disulfiram Treatment COMPLETED	6
Disulfiram Treatment NOT COMPLETED	1
Optional 28 Days of Disulfiram Treatment STARTED	6
Optional 28 Days of Disulfiram Treatment COMPLETED	4
Optional 28 Days of Disulfiram Treatment NOT COMPLETED	2

Reasons for withdrawal

Measure	Disulfiram Patients in this arm will receive disulfiram 250 mg daily for a total of 42 days. Disulfiram: 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.
Disulfiram Treatment Lost to Follow-up	1
Optional 28 Days of Disulfiram Treatment Lost to Follow-up	2

Baseline Characteristics

Neural Mechanisms of Disulfiram Effects

Baseline characteristics by cohort

Measure	Disulfiram n=7 Participants Patients in this arm will receive disulfiram 250 mg daily for a total of 42 days. Disulfiram: 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.
Age, Continuous	47.6 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants
Baseline Drinking days (prior 28 days)	24.0 days STANDARD_DEVIATION 2.3 • n=5 Participants

PRIMARY outcome

Timeframe: 42 days

Population: Participants who completed the initial 42 days of disulfiram treatment

Number of drinking days

Outcome measures

Measure

Disulfiram n=6 Participants Patients in this arm will receive disulfiram 250 mg daily for a total of 42 days. Disulfiram: 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.

Alcohol Use

0 days Standard Deviation 0

Adverse Events

Disulfiram

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nasir Naqvi, MD

New York State Psychiatric Institute

Phone: 6467748181

Email: nasir.naqvi@nyspi.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place