Opioids and Social Support Enhanced Extinction Effects

Fear Clinical Trial

— SSO  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04166071
• Other study ID #: SSO
• Secondary ID: R21MH115287
• Status: Enrolling by invitation
• Phase: Early Phase 1
• Start date: December 13, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fear

Intervention

Drug:
• Naltrexone
Half of the participants will be randomly assigned to take one dose of naltrexone (50mg, capsule form) during the experimental session
• Placebo
Half of the participants will be randomly assigned to take a placebo capsule during the experimental session

Locations

Country	Name	City	State
United States	UCLA	Los Angeles	California
United States	UCLA Department of Psychology, 5514 Pritzker Hall	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).