Opioids and Social Support Enhanced Extinction Effects (SSO)

Revisiting Safety Signals: Examining a Separate Safety Mechanism for Social Support Figures

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Fear
• Intervention / Treatment: Drug: Naltrexone; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Erica Hornstein, Ph.D.; Phone Number: 9175664470; Email: ericahornstein@ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA
    • Los Angeles, California, United States, 90095-1563
      • UCLA Department of Psychology, 5514 Pritzker Hall

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

Other exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Half of the participants will be randomly assigned to take a placebo capsule during the experimental session
Active Comparator: Naltrexone	Drug: Naltrexone; Half of the participants will be randomly assigned to take one dose of naltrexone (50mg, capsule form) during the experimental session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Naomi Eisenberger, Ph.D., University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: November 14, 2019
• First Posted (Actual): November 18, 2019

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: social support; fear extinction
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Alcohol Deterrents; Naltrexone
• Other Study ID Numbers: SSO; R21MH115287 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No