An fMRI Study of Opioid-related Changes in Neural Activity | NCT02818036

An fMRI Study of Opioid-related Changes in Neural Activity | NCT02818036 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
naltrexone	Experimental	single 50mg dose of naltrexone	Drug: Naltrexone
sugar pill	Placebo Comparator	single sugar pill	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Naltrexone	Drug		naltrexone
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bold Oxygen-level Dependent (BOLD) Activations in Prespecified ROIs	In the MRI scanner, participants read sentences written by people they knew and people they did not know in a block design. Brain activity was measured as BOLD activity in response to reading sentences from known (vs. unknown) people using functional magnetic resonance imaging (FMRI). Based on a priori hypotheses, brain activity was masked to activity in structural regions-of-interest (ROIs) of the ventral striatum (VS) and middle-insula (MI).	approximately one hour after taking study drug
Self-reported Feelings of Connection in Response to the Scanner Tasks	feelings of social connection in response to reading sentences from known people (i.e. average of how connected, touched, warm did you feel). Feelings were reported on a scale of 1 (not at all) to 7 (very) such that higher numbers reflect greater feelings of social connection. time frame was mistakenly entered as the start of the fMRI scan, but participants reported on their feelings of social connection after the scan. Thus, the outcome measure time frame is reported as two, rather than one, hour after taking the study drug.	approximately two hours after taking study drug

Facility	Status	City	State	ZIP	Country	Contacts
University of Pittsburgh		Pittsburgh	Pennsylvania	15260	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34292204	Derived	Ross LP, Andreescu C, Inagaki TK. Relationships Between Early Maternal Warmth and Social Connection: A Randomized Clinical Trial With Naltrexone. Psychosom Med. 2021 Oct 1;83(8):924-931. doi: 10.1097/PSY.0000000000000986.
31414860	Derived	Inagaki TK, Hazlett LI, Andreescu C. Opioids and social bonding: Effect of naltrexone on feelings of social connection and ventral striatum activity to close others. J Exp Psychol Gen. 2020 Apr;149(4):732-745. doi: 10.1037/xge0000674. Epub 2019 Aug 15.

ID	Title	Description
FG000	Naltrexone	single 50mg dose of naltrexone Naltrexone
FG001	Sugar Pill	single sugar pill Placebo

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00042 subjects FG00140 subjects
COMPLETED		FG00040 subjects FG00140 subjects
NOT COMPLETED		FG0002 subjects FG0010 subjects

Type	Comment	Reasons
head did not fit in fMRI scanner headres		FG0001 subjects FG0010 subjects
Withdrawal by Subject		FG0001 subjects FG001

Baseline Characteristics Module

ID	Title	Description
BG000	Naltrexone	single 50mg dose of naltrexone Naltrexone
BG001	Sugar Pill	single sugar pill Placebo

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Bold Oxygen-level Dependent (BOLD) Activations in Prespecified ROIs

In the MRI scanner, participants read sentences written by people they knew and people they did not know in a block design. Brain activity was measured as BOLD activity in response to reading sentences from known (vs. unknown) people using functional magnetic resonance imaging (FMRI). Based on a priori hypotheses, brain activity was masked to activity in structural regions-of-interest (ROIs) of the ventral striatum (VS) and middle-insula (MI).

all participants, 3 excluded from sugar pill group (1 for poor registration during preprocessing, 1 for technical error with task presentation, 1 for signal dropout in primary regions of interest)

Posted

Mean

Standard Error

BOLD signal

approximately one hour after taking study drug

ID	Title	Description
OG000	Naltrexone	single 50mg dose of naltrexone Naltrexone

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Naltrexone	single 50mg dose of naltrexone Naltrexone	0

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Dr. Tristen Inagaki	University of Pittsburgh	412-624-4211		inagaki@pitt.edu

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 13, 2015	Jul 17, 2019	Prot_SAP_000.pdf

Intervention Browse Module

ID	Term
D009271	Naltrexone

ID	Term
D009270	Naloxone
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG0020
Asian	BG00010 BG00112 BG00222
Native Hawaiian or Other Pacific Islander	BG0000 BG0010 BG0020
Black or African American	BG0001 BG0012 BG0023
White	BG00027 BG00123 BG00250
More than one race	BG0002 BG0012 BG0024
Unknown or Not Reported	BG0000 BG0011 BG0021

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		t-test, 1 sided	degrees of freedom = 75	<.01	a priori threshold for significance was p<.05													Other	difference in neural activity to social task when taking naltrexone as compared to placebo

Primary

Self-reported Feelings of Connection in Response to the Scanner Tasks

feelings of social connection in response to reading sentences from known people (i.e. average of how connected, touched, warm did you feel). Feelings were reported on a scale of 1 (not at all) to 7 (very) such that higher numbers reflect greater feelings of social connection.

time frame was mistakenly entered as the start of the fMRI scan, but participants reported on their feelings of social connection after the scan. Thus, the outcome measure time frame is reported as two, rather than one, hour after taking the study drug.

All participants. Ratings from 1 participant in the naltrexone group were misplaced. 1 participant from the sugar pill group did not follow instructions and so ratings were not included in final analyses.

Posted

Mean

Standard Deviation

scores on a scale

approximately two hours after taking study drug

ID	Title	Description
OG000	Naltrexone	single 50mg dose of naltrexone Naltrexone
OG001	Sugar Pill	single sugar pill Placebo

Units	Counts
Participants	OG00039 OG00139

Title

Denominators