Trial Outcomes & Findings for Neural Substrates of Emotion: Impact of Cocaine Dependence (NCT NCT02682784)

Last Updated: 2021-10-21

Results Overview

Psychophysiological interaction (PPI) analysis measures how strongly one region of the brain is connected to another brain region during a particular experimental condition, such as doing arithmetic while being given feedback about performance. The strength of this functional connection between two regions can be expressed as a parameter estimate - the higher the value of the parameter estimate, the more strongly connected the two regions are so that as activation in one region increases, activation in the connected region also increases. However, two regions can also be strongly negatively connected such that if activation in one region goes up during a task condition, activation in the other region goes down

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

138 participants

Primary outcome timeframe

During Montreal Imaging Stress Task in fMRI scanner

Results posted on

2021-10-21

Participant Flow

Participant milestones

Participant milestones
Measure	Oxytocin/Cocaine User Individuals who meet criteria for cocaine use disorder and are randomized to oxytocin. Oxytocin: Nasal spray based on naturally occurring hormone, oxytocin.	Placebo/Cocaine User Individuals who meet criteria for cocaine use disorder and are randomized to placebo. Placebo	Oxytocin/Control Healthy controls who are randomized to oxytocin. Oxytocin: Nasal spray based on naturally occurring hormone, oxytocin.	Placebo/Control Healthy controls who are randomized to placebo. Placebo
Overall Study STARTED	40	37	29	32
Overall Study COMPLETED	39	35	27	29
Overall Study NOT COMPLETED	1	2	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Oxytocin/Cocaine User Individuals who meet criteria for cocaine use disorder and are randomized to oxytocin. Oxytocin: Nasal spray based on naturally occurring hormone, oxytocin.	Placebo/Cocaine User Individuals who meet criteria for cocaine use disorder and are randomized to placebo. Placebo	Oxytocin/Control Healthy controls who are randomized to oxytocin. Oxytocin: Nasal spray based on naturally occurring hormone, oxytocin.	Placebo/Control Healthy controls who are randomized to placebo. Placebo
Overall Study Withdrawal by Subject	0	2	1	2
Overall Study Physician Decision	1	0	1	1

Baseline Characteristics

Neural Substrates of Emotion: Impact of Cocaine Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxytocin/Cocaine User n=39 Participants Individuals who meet criteria for cocaine use disorder and are randomized to oxytocin. Oxytocin: Nasal spray based on naturally occurring hormone, oxytocin.	Placebo/Cocaine User n=35 Participants Individuals who meet criteria for cocaine use disorder and are randomized to placebo. Placebo	Oxytocin/Control n=27 Participants Healthy controls who are randomized to oxytocin. Oxytocin: Nasal spray based on naturally occurring hormone, oxytocin.	Placebo/Control n=29 Participants Healthy controls who are randomized to placebo. Placebo	Total n=130 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants	34 Participants n=7 Participants	27 Participants n=5 Participants	29 Participants n=4 Participants	129 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	16 Participants n=7 Participants	15 Participants n=5 Participants	13 Participants n=4 Participants	57 Participants n=21 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	19 Participants n=7 Participants	12 Participants n=5 Participants	16 Participants n=4 Participants	73 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants	35 Participants n=7 Participants	26 Participants n=5 Participants	28 Participants n=4 Participants	128 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	39 participants n=5 Participants	35 participants n=7 Participants	27 participants n=5 Participants	29 participants n=4 Participants	130 participants n=21 Participants

PRIMARY outcome

Timeframe: During Montreal Imaging Stress Task in fMRI scanner

Population: Some scans were not useable to due to head movement.

Outcome measures

Outcome measures
Measure	Oxytocin/Cocaine User n=35 Participants Individuals who meet criteria for cocaine use disorder and are randomized to oxytocin. Oxytocin: Nasal spray based on naturally occurring hormone, oxytocin.	Placebo/Cocaine User n=27 Participants Individuals who meet criteria for cocaine use disorder and are randomized to placebo. Placebo	Oxytocin/Control n=27 Participants Healthy controls who are randomized to oxytocin. Oxytocin: Nasal spray based on naturally occurring hormone, oxytocin.	Placebo/Control n=24 Participants Healthy controls who are randomized to placebo. Placebo
Functional Connectivity Between Corticolimbic Brain Regions During Acute Social Stress	.011 Arbitrary units Standard Deviation .099	.012 Arbitrary units Standard Deviation .103	.043 Arbitrary units Standard Deviation .097	.0008 Arbitrary units Standard Deviation .149

PRIMARY outcome

Timeframe: During Facial Recognition Task in fMRI scanner

Population: Some scans were not useable due to head movement.

Use an implicit facial affect recognition paradigm to determine the impact of cocaine dependence and oxytocin on amygdala activity in response to fearful faces. The BOLD signal measured during neutral faces will be subtracted from the BOLD signal measured during fearful faces.

Outcome measures

Outcome measures
Measure	Oxytocin/Cocaine User n=30 Participants Individuals who meet criteria for cocaine use disorder and are randomized to oxytocin. Oxytocin: Nasal spray based on naturally occurring hormone, oxytocin.	Placebo/Cocaine User n=18 Participants Individuals who meet criteria for cocaine use disorder and are randomized to placebo. Placebo	Oxytocin/Control n=23 Participants Healthy controls who are randomized to oxytocin. Oxytocin: Nasal spray based on naturally occurring hormone, oxytocin.	Placebo/Control n=24 Participants Healthy controls who are randomized to placebo. Placebo
Amygdala Activity in Response to Fearful Faces	8.33 Bold signal Standard Deviation 48.9	2.32 Bold signal Standard Deviation 47.6	11.98 Bold signal Standard Deviation 30.4	18.07 Bold signal Standard Deviation 30.8

Adverse Events

Oxytocin/Cocaine User

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo/Cocaine User

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Oxytocin/Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo/Control

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

Lisa Nunn

Medical University of South Carolina

Phone: 843-792-0476

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place