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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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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).
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