Trial Outcomes & Findings for Oxytocin and Stress Response in Alcohol Use Disorder (NCT NCT03610633)

Last Updated: 2019-10-23

Results Overview

Corticolimbic functional connectivity will be determined using psychophysiological interaction (PPI) modeling. The left and right amygdala will serve as seed regions. Connectivity of each seed region with the homologous orbitofrontal cortex region will be represented as a parameter estimate, yielding one parameter estimate for right amygdala-right orbitofrontal connectivity and one parameter estimate for left amygdala-left orbitofrontal connectivity per subject.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

60 minutes following medication (oxytocin or placebo)

Results posted on

2019-10-23

Participant Flow

Participant milestones

Participant milestones
Measure	Oxytocin/Alcohol Use Disorder Participants will receive 24 IU of oxytocin prior to completing fMRI scanning procedures. Oxytocin: The neuropeptide oxytocin (OT) increases social approach, trust, and reduces anxiety to social stress.	Placebo/Alcohol Use Disorder Participants will receive placebo (saline solution) prior to completing fMRI scanning procedures. Placebo: Saline solution.
Overall Study STARTED	5	6
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oxytocin and Stress Response in Alcohol Use Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxytocin/Alcohol Use Disorder n=5 Participants Participants will receive 24 IU of oxytocin prior to completing fMRI scanning procedures. Oxytocin: The neuropeptide oxytocin (OT) increases social approach, trust, and reduces anxiety to social stress.	Placebo/Alcohol Use Disorder n=5 Participants Participants will receive placebo (saline solution) prior to completing fMRI scanning procedures. Placebo: Saline solution.	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=99 Participants	5 Participants n=107 Participants	10 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	25.2 years n=99 Participants	24 years n=107 Participants	24.6 years n=206 Participants
Sex: Female, Male Female	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants
Sex: Female, Male Male	4 Participants n=99 Participants	3 Participants n=107 Participants	7 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) White	4 Participants n=99 Participants	5 Participants n=107 Participants	9 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	5 participants n=99 Participants	5 participants n=107 Participants	10 participants n=206 Participants

PRIMARY outcome

Timeframe: 60 minutes following medication (oxytocin or placebo)

Outcome measures

Outcome measures
Measure	Oxytocin/Alcohol Use Disorder n=5 Participants Participants will receive 24 IU of oxytocin prior to completing fMRI scanning procedures. Oxytocin: The neuropeptide oxytocin (OT) increases social approach, trust, and reduces anxiety to social stress.	Placebo/Alcohol Use Disorder n=5 Participants Participants will receive placebo (saline solution) prior to completing fMRI scanning procedures. Placebo: Saline solution.
Corticolimbic Functional Connectivity Based on fMRI Blood Oxygenation Level Dependent (BOLD) Response During the Stress Versus Neutral Conditions of the Montreal Imaging Stress Test Task Averaged Over the Second and Third Functional Runs Left amygdala left orbitofrontal connectivity	-.12723 contrast of parameter estimates Standard Deviation .103532	-.04836 contrast of parameter estimates Standard Deviation .150718
Corticolimbic Functional Connectivity Based on fMRI Blood Oxygenation Level Dependent (BOLD) Response During the Stress Versus Neutral Conditions of the Montreal Imaging Stress Test Task Averaged Over the Second and Third Functional Runs Right amygdala right orbitofrontal connectivity	.042561 contrast of parameter estimates Standard Deviation .155865	-.06624 contrast of parameter estimates Standard Deviation .240009

Adverse Events

Oxytocin/Alcohol Use Disorder

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo/Alcohol Use Disorder

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

Laura Lohnes

Medical University of South Carolina

Phone: 843-792-7709

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place