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Enrolling by invitation NCT04166071

Opioids and Social Support Enhanced Extinction Effects

Early Phase I Interventional Fear

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Naltrexone, Placebo.
Who it may be relevant to
Registry conditions: Fear. Basic parameters: 18 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Fear Response directly post-extinction [Time frame: Directly following a fear extinction procedure (during the experiment session).]
  • Fear Response 24-hours post-extinction [Time frame: 24 hours following the completion of the fear extinction procedure (during a follow-up fear reinstatement session).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

United States · 2 centers
  • UCLA Department of Psychology, 5514 Pritzker Hall — Los Angeles
  • UCLA — Los Angeles

Identifiers

NCT: NCT04166071 · SSO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗