Trial Outcomes & Findings for Imaging Glutamate Release From Alcohol (NCT NCT04159688)

NCT ID: NCT04159688

Last Updated: 2024-10-09

Results Overview

The percent change in receptor availability will be measured from the PET data. Since this project is for basic science it is not known whether positive values are better or worse outcome.

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 8 participants
• Primary outcome timeframe: Baseline and within 2 hours of challenge
• Results posted on: 2024-10-09

Participant Flow

Participant milestones

Measure	Alcohol Challenge Alcohol Challenge, oral, targeting BAL of 60 mg/dL, Given once Alcohol: Alcohol Challenge
Overall Study STARTED	8
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Imaging Glutamate Release From Alcohol

Baseline characteristics by cohort

Measure	Alcohol Challenge n=8 Participants Alcohol Challenge, oral, targeting BAL of 60 mg/dL, Given once Alcohol: Alcohol Challenge
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	28 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	3 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and within 2 hours of challenge

The percent change in receptor availability will be measured from the PET data. Since this project is for basic science it is not known whether positive values are better or worse outcome.

Outcome measures

Measure	Alcohol Challenge n=7 Participants Alcohol Challenge, oral, targeting BAL of 60 mg/dL, Given once Alcohol: Alcohol Challenge
Alcohol-induced Change in Receptor Availability	-9.1 percentage change of BP_ND Interval -11.2 to -6.6

Adverse Events

Alcohol Challenge

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

Dr. Ansel Hillmer

Yale University

Phone: 203-737-6400

Email: ansel.hillmer@yale.edu

Results disclosure agreements

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