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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05007561
Recruitment Status : Recruiting
First Posted : August 16, 2021
Last Update Posted : March 10, 2022
Sponsor:
Information provided by (Responsible Party):
Tristen Inagaki, San Diego State University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Naltrexone Placebo Drug: Naltrexone Hydrochloride Drug: Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Understanding How Opioids Affect the Experiential and Neural Signatures of Social Experiences
Actual Study Start Date : November 16, 2021
Estimated Primary Completion Date : April 2026
Estimated Study Completion Date : July 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Naltrexone
50mg naltrexone HCL once daily for seven days by mouth
Drug: Naltrexone Hydrochloride
oral naltrexone
Other Names:
  • oral naltrexone
  • naltrexone pill
  • naltrexone
  • naltrexone oral tablet

Placebo Comparator: placebo
sugar pill once daily for seven days by mouth
Drug: Placebo
oral sugar pill
Other Name: sugar pill




Primary Outcome Measures :
  1. Daily feelings of social connection via ecological momentary assessment [ Time Frame: post-treatment, change across 7 days ]
    State feelings of social connection outside of the lab

  2. Bold Oxygen-level Dependent (BOLD) Activations in Prespecified ROIs [ Time Frame: Day 7, approximately 60 mins after taking study drug ]
    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).

  3. feelings in response to neuroimaging tasks [ Time Frame: Day 7, approximately 150 minutes after taking study drug ]
    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)


Secondary Outcome Measures :
  1. physical symptoms via daily diary [ Time Frame: end of day on days 1-7 ]
    Physical symptoms previously associated with naltrexone will be assessed as well as the subjective experience of the symptoms.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • good health
  • English fluency
  • willing to provide contact information for 4-6 close others
  • willing to provide digital photographs of 2 close others
  • own a smartphone

Exclusion Criteria:

  • 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
  • self-reported chronic mental or physical illness
  • current and regular use of prescription medication
  • previous history of having difficulty taking pills
  • current use of opioid analgesics
  • depressive symptoms above a 9 on Patient Health Questionnaire
  • excessive alcohol use
  • positive urine drug test
  • body mass index (BMI) greater than 35
  • pregnancy or plans to become pregnant in next 6 months
  • positive urine pregnancy test

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05007561


Contacts
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Contact: Tristen Inagaki, PhD 6195941239 tinagaki@sdsu.edu

Locations
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United States, California
San Diego State University Recruiting
San Diego, California, United States, 92120
Contact: Tristen Inagaki, PhD         
Sponsors and Collaborators
San Diego State University
Investigators
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Principal Investigator: Tristen Inagaki, PhD San Diego State University
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Responsible Party: Tristen Inagaki, Assistant Professor, San Diego State University
ClinicalTrials.gov Identifier: NCT05007561    
Other Study ID Numbers: R01DA052883 ( U.S. NIH Grant/Contract )
First Posted: August 16, 2021    Key Record Dates
Last Update Posted: March 10, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data and resources from the current study will be deposited in the Open Science Framework (OSF) and OpenNEURO.org, in accordance with the NIH Data Sharing Policy. In addition, results will be posted on the ClinicalTrials.gov website within 1 year of the study's completion date.
Supporting Materials: Analytic Code
Time Frame: After publication of the primary findings.
Access Criteria: Researchers in both private and public sector

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Naltrexone
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents