Social AcceptanceNCT02818036

An fMRI Study of Opioid-related Changes in Neural Activity

A study testing Naltrexone in people with Social Acceptance, run by Tristen Inagaki at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of the study is to explore the effect of blocking opioids on affiliation-related neural activity. Read more about this study

Who is it for?: Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Social Acceptance
What is being tested?: Naltrexone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 82 participants
Where: 1 siteUnited States
Study dates: Aug 2016to 21 Jun 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

good health
between the ages of 18 and 35,
fluent in English
right-handed (for the fMRI scan)

Who cannot join

Self-reported current or past diagnoses of physical or mental illness.
Score on the Patient Health Questionnaire (depressive symptoms) above a 13
Positive urine drug test (for Tetrahydrocannabinol (THC), Opiates, Cocaine, Amphetamine (AMP), and Methamphetamine (mAMP))
Positive urine pregnancy test
Use of any prescription medication, except for birth control
Use of any over-the-counter medications on the day of the fMRI session and 24 hours after the fMRI session

Show all 11Show fewer

Self-reported problems with liver functioning, including hepatitis or liver failure
Difficulty swallowing or taking pills
BMI greater than 35 or weight greater than 400 lbs
Claustrophobia
Nonremovable metal in the body

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh
Pittsburgh, Pennsylvania, 15260

Other trials in United States

About this study

The purpose of the study is to explore the effect of blocking opioids on affiliation-related neural activity.

Conditions: Social Acceptance
Being tested: Naltrexone, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NaltrexoneDrug
PlaceboDrug

Study groups in NCT02818036
Study group	Role	What they receive
naltrexone	Experimental	single 50mg dose of naltrexone Receives: Drug: Naltrexone
sugar pill	Placebo comparator	single sugar pill Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: approximately two hours after taking study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 201621 Jun 2018

First posted29 Jun 2016 (estimated)
Study startAug 2016
Primary completion21 Jun 2018
Study completion21 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Social AcceptanceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02818036
Sponsor's protocol ID: PRO15010292
Status last verified: Jul 2019
First submitted: 20 Jun 2016
Last updated: 23 Jul 2019
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 34292204
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.
PubMed 31414860

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Quality of Life

All Social Acceptance trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An fMRI Study of Opioid-related Changes in Neural Activity
ClinicalTrials.gov ID: NCT02818036
Acronym / sponsor ID: PRO15010292
Conditions: Social Acceptance
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: Tristen InagakiUniversity, hospital or other
Study start: Aug 2016
Primary completion: 21 Jun 2018 (actual)
Study completion: 21 Jun 2018 (actual)
First posted: 29 Jun 2016 (estimated)
Results: Posted 23 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study is to explore the effect of blocking opioids on affiliation-related neural activity.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
naltrexone	Experimental	Drug: Naltrexonesingle 50mg dose of naltrexone
sugar pill	Placebo comparator	Drug: Placebosingle sugar pill

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

good health
between the ages of 18 and 35,
fluent in English
right-handed (for the fMRI scan)

Key exclusion criteria (11 listed)

Self-reported current or past diagnoses of physical or mental illness.
Score on the Patient Health Questionnaire (depressive symptoms) above a 13
Positive urine drug test (for Tetrahydrocannabinol (THC), Opiates, Cocaine, Amphetamine (AMP), and Methamphetamine (mAMP))
Positive urine pregnancy test
Use of any prescription medication, except for birth control

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Naltrexone	Drug	naltrexone
Placebo	Drug	sugar pill

Primary outcome

Bold Oxygen-level Dependent (BOLD) Activations in Prespecified ROIs
Time frame: approximately one hour after taking study drug
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).
Self-reported Feelings of Connection in Response to the Scanner Tasks
Time frame: approximately two hours after taking study drug
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.

Results and safety

Results posted to the registry on 23 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Naltrexone	42	40
Sugar Pill	40	40

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

Time frame: approximately one hour after taking study drug. Mean (Standard Error). Unit: BOLD signal

Measure	Naltrexone n = 40	Sugar Pill n = 37
Value	0.117 (0.033)	0.2545 (0.061)

Naltrexone vs Sugar Pill: p <.01, t-test, 1 sided

Population analysed: 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)

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

Time frame: approximately two hours after taking study drug. Mean (Standard Deviation). Unit: scores on a scale

Measure	Naltrexone n = 39	Sugar Pill n = 39
Value	4.576 (.848)	4.766 (.895)

Naltrexone vs Sugar Pill: p = .338, t-test, 2 sided

Population analysed: 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.

Adverse events

Time frame: Symptoms in response to taking the study drugs were collected approximately three hours after drug administration. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Naltrexone	0 of 40 (0%)	30 of 40 (75%)	0 of 40
Sugar Pill	0 of 40 (0%)	20 of 40 (50%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34292204Ross 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.
Derived from this study: PubMed 31414860Inagaki 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.

Related trials for Social Acceptance

Active, not recruiting
Self-Help Plus (SH+) for Stress Reduction in Social Service Workers: A Pilot RCT
Stress, Psychological, Occupational, Stress, Psychological
Not yet recruiting
The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veterans
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The AYA Oncology Self-care Movement
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Naltrexone in people with Social Acceptance, run by Tristen Inagaki at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bold Oxygen-level Dependent (BOLD) Activations in Prespecified ROIs (time frame: approximately one hour after taking study drug). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02818036, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.