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Opioids and Social Support Enhanced Extinction Effects (SSO)

University of California, Los Angeles (UCLA) logo

University of California, Los Angeles (UCLA)

Status and phase

Invitation-only
Early Phase 1

Conditions

Fear

Treatments

Drug: Placebo
Drug: Naltrexone

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04166071
SSO
R21MH115287 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups, including a placebo group

Naltrexone
Active Comparator group
Treatment:
Drug: Naltrexone
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

2

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Central trial contact

Erica Hornstein, Ph.D.

Data sourced from clinicaltrials.gov

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