Opioids and Social Support Enhanced Extinction Effects

Study Overview
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Brief Summary
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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.

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

Conditions
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Fear

Intervention / Treatment
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* Drug: Naltrexone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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social support, fear extinction