Health TrialsbyHealthPanel

Understanding How Opioids Affect the Experiential and Neural Signatures of Social Experiences

ConditionsNaltrexonePlacebo
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-25
SponsorSan Diego State University

About this trial

The study is a randomized, placebo-controlled design with the opioid antagonist, oral naltrexone. Following random assignment, participants will take 50mg of naltrexone or placebo once a day for 7 days. On days 1 - 7, participants complete reports of their feelings of social connection and mood in order to assess more naturalistic feelings in response to opportunities for social connection outside of the laboratory setting. Additionally, at the end of each day, they complete a physical symptoms questionnaire. On the 7th day, participants will come to the SDSU MRI scanning facility to complete tasks designed to elicit feelings of social connection in the fMRI scanner. After the scan, feelings in response to the scanner tasks will be collected.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

good health

English fluency

willing to provide contact information for 4-6 close others

willing to provide digital photographs of 2 close others

Disqualifiers

presence of medical devices, implants, or other metal objects in or on the body that cannot be removed

tattooed eyeliner

a body habitus prohibiting MRI scanning

claustrophobia

Trial design

Design model

Parallel

Treatments tested in this trial

  • Naltrexone Hydrochloride

    Drug

    oral naltrexone

  • Placebo

    Drug

    oral sugar pill

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: NaltrexoneExperimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Daily feelings of social connection via ecological momentary assessment

State feelings of social connection outside of the lab

Time frame
post-treatment, change across 7 days
2

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

In the MRI scanner, participants read sentences written by people they know and people they do not know in a block design. In a second task they view images of people they know, those they do not know, and other emotional images. Brain activity will be measured as BOLD activity in response to stimuli from known (vs. unknown) people using functional magnetic resonance imaging (FMRI). Based on a priori hypotheses, brain activity will be masked to activity in structural regions-of- interest (ROIs) of the ventral striatum (VS), middle-insula (MI), anterior cingulate cortex (ACC) and ventromedial prefrontal cortex (VMPFC).

Time frame
Day 7, approximately 60 mins after taking study drug
3

feelings in response to neuroimaging tasks

Feelings of social connection and general positive affect in response to the neuroimaging tasks will be reported on a scale of 1 (not at all) to 7 (very)

Time frame
Day 7, approximately 150 minutes after taking study drug

Secondary outcomes

1

physical symptoms via daily diary

Physical symptoms previously associated with naltrexone will be assessed as well as the subjective experience of the symptoms.

Time frame
end of day on days 1-7

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

San Diego State University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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