Trial Outcomes & Findings for An fMRI Study of Opioid-related Changes in Neural Activity (NCT NCT02818036)

Last Updated: 2019-07-23

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

82 participants

Primary outcome timeframe

approximately one hour after taking study drug

Results posted on

2019-07-23

Participant Flow

Participant milestones

Participant milestones
Measure	Naltrexone single 50mg dose of naltrexone Naltrexone	Sugar Pill single sugar pill Placebo
Overall Study STARTED	42	40
Overall Study COMPLETED	40	40
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Naltrexone single 50mg dose of naltrexone Naltrexone	Sugar Pill single sugar pill Placebo
Overall Study head did not fit in fMRI scanner headres	1	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

An fMRI Study of Opioid-related Changes in Neural Activity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Naltrexone n=40 Participants single 50mg dose of naltrexone Naltrexone	Sugar Pill n=40 Participants single sugar pill Placebo	Total n=80 Participants Total of all reporting groups
Age, Continuous	21.90 years STANDARD_DEVIATION 3.49 • n=5 Participants	22.88 years STANDARD_DEVIATION 3.20 • n=7 Participants	22.39 years STANDARD_DEVIATION 3.362 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	21 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	19 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	23 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Body Mass Index (BMI)	24.30 kg/m^2 STANDARD_DEVIATION 3.60 • n=5 Participants	23.42 kg/m^2 STANDARD_DEVIATION 2.61 • n=7 Participants	23.86 kg/m^2 STANDARD_DEVIATION 3.15 • n=5 Participants

PRIMARY outcome

Timeframe: approximately one hour after taking study drug

Population: 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)

Outcome measures

Outcome measures
Measure	Naltrexone n=40 Participants single 50mg dose of naltrexone Naltrexone	Sugar Pill n=37 Participants single sugar pill Placebo
Bold Oxygen-level Dependent (BOLD) Activations in Prespecified ROIs	0.117 BOLD signal Standard Error 0.033	0.2545 BOLD signal Standard Error 0.061

PRIMARY outcome

Timeframe: approximately two hours after taking study drug

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Naltrexone n=39 Participants single 50mg dose of naltrexone Naltrexone	Sugar Pill n=39 Participants single sugar pill Placebo
Self-reported Feelings of Connection in Response to the Scanner Tasks	4.576 scores on a scale Standard Deviation .848	4.766 scores on a scale Standard Deviation .895

Adverse Events

Naltrexone

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Sugar Pill

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Naltrexone n=40 participants at risk single 50mg dose of naltrexone Naltrexone	Sugar Pill n=40 participants at risk single sugar pill Placebo
Gastrointestinal disorders Nausea	15.0% 6/40 • Symptoms in response to taking the study drugs were collected approximately three hours after drug administration Symptoms were collected on a 0 - 4 scale, with 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms, 4 = very severe symptoms.	7.5% 3/40 • Symptoms in response to taking the study drugs were collected approximately three hours after drug administration Symptoms were collected on a 0 - 4 scale, with 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms, 4 = very severe symptoms.
Gastrointestinal disorders Stomach pain	10.0% 4/40 • Symptoms in response to taking the study drugs were collected approximately three hours after drug administration Symptoms were collected on a 0 - 4 scale, with 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms, 4 = very severe symptoms.	7.5% 3/40 • Symptoms in response to taking the study drugs were collected approximately three hours after drug administration Symptoms were collected on a 0 - 4 scale, with 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms, 4 = very severe symptoms.
General disorders Fatigue	70.0% 28/40 • Symptoms in response to taking the study drugs were collected approximately three hours after drug administration Symptoms were collected on a 0 - 4 scale, with 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms, 4 = very severe symptoms.	47.5% 19/40 • Symptoms in response to taking the study drugs were collected approximately three hours after drug administration Symptoms were collected on a 0 - 4 scale, with 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms, 4 = very severe symptoms.
Nervous system disorders Dizziness	37.5% 15/40 • Symptoms in response to taking the study drugs were collected approximately three hours after drug administration Symptoms were collected on a 0 - 4 scale, with 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms, 4 = very severe symptoms.	10.0% 4/40 • Symptoms in response to taking the study drugs were collected approximately three hours after drug administration Symptoms were collected on a 0 - 4 scale, with 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms, 4 = very severe symptoms.
Nervous system disorders Headache	25.0% 10/40 • Symptoms in response to taking the study drugs were collected approximately three hours after drug administration Symptoms were collected on a 0 - 4 scale, with 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms, 4 = very severe symptoms.	12.5% 5/40 • Symptoms in response to taking the study drugs were collected approximately three hours after drug administration Symptoms were collected on a 0 - 4 scale, with 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms, 4 = very severe symptoms.

Additional Information

Dr. Tristen Inagaki

University of Pittsburgh

Phone: 412-624-4211

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place