Naltrexone for Anxiety
(SSO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that participants do not have a history of mental illness or take medications related to mental health disorders or liver function. If you are currently taking such medications, you would not be eligible to participate.
Is naltrexone safe for humans?
How does the drug naltrexone differ from other treatments for anxiety?
Naltrexone is unique because it is traditionally used to treat alcohol and opioid dependence by blocking the effects of these substances, and its use for anxiety is novel. Unlike typical anxiety medications, naltrexone is available in a long-acting injectable form, which can provide a steady release and potentially reduce side effects.13678
What data supports the effectiveness of the drug Naltrexone for anxiety?
Research shows that Naltrexone is effective in reducing alcohol cravings and relapse rates in alcohol-dependent patients, and it may also help those with high levels of anxiety and distress. This suggests it could potentially be useful for anxiety, although direct evidence for anxiety treatment is not provided.136910
Who Is on the Research Team?
Naomi Eisenberger, Ph.D.
Principal Investigator
University of California, Los Angeles
Are You a Good Fit for This Trial?
Healthy adults aged 18-35 with no history of mental illness or chronic physical conditions, not pregnant, and without liver disease. Participants must be fluent in English and comfortable swallowing pills. Those with a history of substance abuse or on certain medications are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a fear extinction procedure with naltrexone or placebo administration
Follow-up
Participants return for a follow-up test to determine if fear extinction was successful
What Are the Treatments Tested in This Trial?
Interventions
- Naltrexone
- Placebo
Naltrexone is already approved in United States, European Union, Canada for the following indications:
- Alcohol dependence
- Opioid use disorder
- Opioid dependence
- Alcohol dependence
- Opioid use disorder
- Alcohol dependence
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator