Trial Outcomes & Findings for Naltrexone Neuroimaging (NCT NCT04935931)

NCT ID: NCT04935931

Last Updated: 2023-10-12

Results Overview

Change in %BOLD following single dose naltrexone (post-pre) within individuals during passive food view task in the nucleus accumbens

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 13 participants
• Primary outcome timeframe: 2 hours post-naltrexone vs baseline
• Results posted on: 2023-10-12

Participant Flow

Participant milestones

Measure	Single Pre/Post Design Pre-naltrexone fMRI Naltrexone: naltrexone 50 mg PO x 1 Post-naltrexone fMRI
Overall Study STARTED	13
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Single Pre/Post Design Pre-naltrexone fMRI Naltrexone: naltrexone 50 mg PO x 1 Post-naltrexone fMRI
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Naltrexone Neuroimaging

Baseline characteristics by cohort

Measure	Single Pre/Post Design n=13 Participants Pre-naltrexone fMRI Naltrexone: naltrexone 50 mg PO x 1 Post-naltrexone fMRI
Age, Categorical <=18 years	9 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	17 years STANDARD_DEVIATION 2.4 • n=5 Participants
Sex/Gender, Customized Gender identity · Female	12 Participants n=5 Participants
Sex/Gender, Customized Gender identity · Male	0 Participants n=5 Participants
Sex/Gender, Customized Gender identity · Other (prefer to self-describe)	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 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	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	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours post-naltrexone vs baseline

Change in %BOLD following single dose naltrexone (post-pre) within individuals during passive food view task in the nucleus accumbens

Outcome measures

Measure	Single Pre/Post Design n=12 Participants Pre-naltrexone fMRI Naltrexone: naltrexone 50 mg PO x 1 Post-naltrexone fMRI
Change in % Blood Oxygenation Level Dependent Change (%BOLD) in the Nucleus Accumbens	-0.08 %BOLD signal change Standard Deviation 0.03

PRIMARY outcome

Timeframe: 2 hours post-naltrexone vs baseline

Change in %BOLD following single dose naltrexone (post-pre) within individuals during monetary incentive delay in dorsal anterior cingulate cortex

Outcome measures

Measure	Single Pre/Post Design n=12 Participants Pre-naltrexone fMRI Naltrexone: naltrexone 50 mg PO x 1 Post-naltrexone fMRI
Change in % Blood Oxygenation Level Dependent Change (%BOLD) in the Dorsal Anterior Cingulate Cortex	0.06 %BOLD signal change Standard Deviation 0.03

SECONDARY outcome

Timeframe: 2 hours post-naltrexone

Population: plasma concentration

Maximum plasma concentration of naltrexone at 2 hours post-single dose

Outcome measures

Measure	Single Pre/Post Design n=12 Participants Pre-naltrexone fMRI Naltrexone: naltrexone 50 mg PO x 1 Post-naltrexone fMRI
Exposure	44.1 nanomolar Standard Deviation 22.7

Adverse Events

Single Pre/Post Design

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Single Pre/Post Design n=13 participants at risk Pre-naltrexone fMRI Naltrexone: naltrexone 50 mg PO x 1 Post-naltrexone fMRI
Nervous system disorders Claustrophobia	7.7% 1/13 • Number of events 1 • 1 day (single study visit)

Additional Information

Dr. Stephani Stancil

Children's Mercy Kansas City

Phone: 816-234-3000

Email: slstancil@cmh.edu

Results disclosure agreements

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