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NCT05007561 · ClinicalTrials.gov registry record · Early Phase 1
Understanding How Opioids Affect the Experiential and Neural Signatures of Social Experiences
A Early Phase 1 study of Placebo and Naltrexone, sponsored by San Diego State University.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 210
- Enrollment target
- 1
- Study location
NCT05007561: Recruiting Early Phase 1 study of Placebo and Naltrexone, sponsored by San Diego State University.
NCT05007561 is a Early Phase 1 study of Placebo and Naltrexone that is actively recruiting participants, run by San Diego State University. The registered enrollment target is 210 participants, above the 154-participant average among 5 other Placebo trials with a reported enrollment target (36% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05007561, a Early Phase 1 study of Placebo and Naltrexone, is actively recruiting participants, sponsored by San Diego State University.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 210 participants
- Enrollment target
- 1
- Study location
Study Summary
The study is a randomized, placebo-controlled design with the opioid antagonist, oral naltrexone. Following random assignment, participants will take 50mg of naltrexone or placebo once a day for 7 days. On days 1 - 7, participants complete reports of their feelings of social connection and mood in order to assess more naturalistic feelings in response to opportunities for social connection outside of the laboratory setting. Additionally, at the end of each day, they complete a physical symptoms questionnaire. On the 7th day, participants will come to the SDSU MRI scanning facility to complete tasks designed to elicit feelings of social connection in the fMRI scanner. After the scan, feelings in response to the scanner tasks will be collected.
Primary Outcome
State feelings of social connection outside of the lab
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Naltrexone Hydrochloride
Study Locations (1)
California
- San Diego State University - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2021-11-16 |
| Est. Completion | 2027-07 |
| Phase | Early Phase 1 |
What NCT05007561 shows while recruiting
NCT05007561 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, above the 154-participant average among 5 other Placebo trials with a reported enrollment target (36% higher).
The record links to 2 conditions, with Placebo appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05007561 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05007561 about?
NCT05007561 is a clinical study titled "Understanding How Opioids Affect the Experiential and Neural Signatures of Social Experiences". The study is a randomized, placebo-controlled design with the opioid antagonist, oral naltrexone. Following random assignment, participants will take 50mg of naltrexone or placebo once a day for 7 days. On days 1 - 7, participants complete reports of their feelings of social connection and mood in o...
What is the current status of trial NCT05007561?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 210 participants. The study started on 2021-11-16. Estimated completion is 2027-07.
What conditions does trial NCT05007561 study?
This clinical trial studies the following conditions: Placebo, Naltrexone.
What interventions are being tested in trial NCT05007561?
The interventions under investigation include: Placebo (DRUG), Naltrexone Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT05007561?
This trial is sponsored by San Diego State University, which has 118 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05007561 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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