Trial Outcomes & Findings for Pregabalin as Treatment for Alcohol Use Disorder (NCT NCT03256253)

NCT ID: NCT03256253

Last Updated: 2020-08-31

Results Overview

Defined as the highest amount of medication per day maintained for a 7 day period.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 18 participants
• Primary outcome timeframe: over the course of the 8 week trial or participants' length of participation
• Results posted on: 2020-08-31

Participant Flow

Participant milestones

Measure	Pregabalin pregabalin up to daily dose of 600 mg Pregabalin: pregabalin up to 600 mg/day
Overall Study STARTED	18
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pregabalin as Treatment for Alcohol Use Disorder

Baseline characteristics by cohort

Measure	Pregabalin n=18 Participants pregabalin up to daily dose of 600 mg Pregabalin: pregabalin up to 600 mg/day
Age, Continuous	40.1 years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 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	2 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	2 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Education	14.1 years STANDARD_DEVIATION 2.5 • n=5 Participants

PRIMARY outcome

Timeframe: over the course of the 8 week trial or participants' length of participation

Population: Data was available for 14 patients

Defined as the highest amount of medication per day maintained for a 7 day period.

Outcome measures

Measure	Pregabalin n=14 Participants pregabalin up to daily dose of 600 mg Pregabalin: pregabalin up to 600 mg/day
Maximum Dose of Pregabalin:	571.4 milligrams Standard Deviation 80.2

Adverse Events

Pregabalin

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pregabalin n=15 participants at risk pregabalin up to daily dose of 600 mg Pregabalin: pregabalin up to 600 mg/day
General disorders drowsiness	26.7% 4/15 • Number of events 4 • Over the course of the 8 week trial or length of participant's participation Data was collected for 15 participants with post-enrollment data
General disorders fogginess	20.0% 3/15 • Number of events 3 • Over the course of the 8 week trial or length of participant's participation Data was collected for 15 participants with post-enrollment data
General disorders dizziness	20.0% 3/15 • Number of events 3 • Over the course of the 8 week trial or length of participant's participation Data was collected for 15 participants with post-enrollment data
General disorders insomnia	20.0% 3/15 • Number of events 3 • Over the course of the 8 week trial or length of participant's participation Data was collected for 15 participants with post-enrollment data
Musculoskeletal and connective tissue disorders back pain	13.3% 2/15 • Number of events 2 • Over the course of the 8 week trial or length of participant's participation Data was collected for 15 participants with post-enrollment data
Eye disorders blurred vision	13.3% 2/15 • Number of events 2 • Over the course of the 8 week trial or length of participant's participation Data was collected for 15 participants with post-enrollment data
General disorders vivid dreams	13.3% 2/15 • Number of events 2 • Over the course of the 8 week trial or length of participant's participation Data was collected for 15 participants with post-enrollment data
General disorders dry mouth	13.3% 2/15 • Number of events 2 • Over the course of the 8 week trial or length of participant's participation Data was collected for 15 participants with post-enrollment data
General disorders fatigue	13.3% 2/15 • Number of events 2 • Over the course of the 8 week trial or length of participant's participation Data was collected for 15 participants with post-enrollment data
General disorders difficulty concentrating	6.7% 1/15 • Number of events 1 • Over the course of the 8 week trial or length of participant's participation Data was collected for 15 participants with post-enrollment data
General disorders dry eyes	6.7% 1/15 • Number of events 1 • Over the course of the 8 week trial or length of participant's participation Data was collected for 15 participants with post-enrollment data
Eye disorders eye infection	6.7% 1/15 • Number of events 1 • Over the course of the 8 week trial or length of participant's participation Data was collected for 15 participants with post-enrollment data
General disorders increased sensitivity to alcohol	6.7% 1/15 • Number of events 1 • Over the course of the 8 week trial or length of participant's participation Data was collected for 15 participants with post-enrollment data
General disorders swollen feet	6.7% 1/15 • Number of events 1 • Over the course of the 8 week trial or length of participant's participation Data was collected for 15 participants with post-enrollment data
Eye disorders eye redness	6.7% 1/15 • Number of events 1 • Over the course of the 8 week trial or length of participant's participation Data was collected for 15 participants with post-enrollment data

Additional Information

John Mariani MD

New York State Psychiatric Institute

Phone: 6467748181

Email: john.mariani@nyspi.columbia.edu

Results disclosure agreements

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