Opioids and Social Support Enhanced Extinction Effects

NCT04166071 | Enrolling By Invitation Early Phase 1 FDA Drug

• 1 other identifier: SSO
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

University of California, Los Angeles researchers will recruit healthy participants (age 18-35) to participate in a study examining whether the administration of naltrexone, an opioid antagonist, eliminates the ability of social support figure reminders to enhance fear extinction--a process during which a threatening cue is learned to not predict a negative or threatening outcome (i.e., electric shock) by being repeatedly presented in the absence of that outcome. After undergoing an email screening, a telephone screening, an in lab screening, and a health screening, 60 participants will be enrolled in the study. During the experiment, 30 participants will be administered naltrexone and 30 participants will be administered placebo (both participants and experimenters will be blind to condition) before undergoing a fear extinction procedure in which threatening cues--cues that predict electric shock--will be paired with either an image of a social support figure (provided by participants) or a second threatening cue. These pairings will be presented repeatedly in the absence of shock in order for fear extinction to occur. Participants will return for a follow-up test to determine if fear extinction was successful.

Conditions

Fear

Keywords

social support; fear extinction

Outcome Measures

Primary Outcomes (2)

• Fear Response directly post-extinction

  presence of fear response as indicated by significantly higher galvanic skin response (GSR: an index of peripheral stress responding) to a previously learned fearful image (CS+) compared to a baseline comparator (CS-: never learned to be fearful).

  Directly following a fear extinction procedure (during the experiment session).

• Fear Response 24-hours post-extinction

  presence of fear response as indicated by significantly higher galvanic skin response (GSR: an index of peripheral stress responding) to a previously learned fearful image (CS+) compared to a baseline comparator (CS-: never learned to be fearful).

  24 hours following the completion of the fear extinction procedure (during a follow-up fear reinstatement session).

Study Arms (2)

Naltrexone

ACTIVE COMPARATOR

Drug: Naltrexone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Naltrexone DRUG

Half of the participants will be randomly assigned to take one dose of naltrexone (50mg, capsule form) during the experimental session

Naltrexone

Placebo DRUG

Half of the participants will be randomly assigned to take a placebo capsule during the experimental session

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy adults 18 and 35
• fluent in English
• no history of mental illness (including anxiety, depression, phobia, or any other mental health related disorder diagnosed by a mental health professional)

You may not qualify if:

• pregnant or planning to become pregnant during the experiment period
• presence of chronic mental illness (as determined by the report of a past diagnosis of mental illness by a physician or psychologist and/or the prescription of medication related to mental health disorder; including anxiety, depression, phobia, or any other diagnosed psychological disorder)
• chronic physical illness (as determined by past diagnosis and/or treatment by a physician)
• history of liver disease or abnormal liver function
• current and regular use of prescription medications related to mental health disorders or liver function
• previous history of fainting during blood draws
• difficulty or discomfort swallowing pills
• history of substance abuse or addiction (especially alcohol or opiate abuse)

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

UCLA Department of Psychology, 5514 Pritzker Hall

Los Angeles, California, 90095-1563, United States

Location

UCLA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Interventions

Naltrexone

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Naomi Eisenberger, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 18, 2019
• Study Start: December 13, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)