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NCT04080427 · ClinicalTrials.gov registry record · Phase 1

Effects of Delta9-tetrahydrocannabinol (THC) on Retention of Memory for Fear Extinction Learning in PTSD: R33 Study

A Phase 1 study, sponsored by Wayne State University.

Completed
Registry status
Phase 1
Development phase
102
Enrollment target

NCT04080427: Completed Phase 1 study, sponsored by Wayne State University.

NCT04080427 is a Phase 1 study that has completed, run by Wayne State University. The registered enrollment target is 102 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04080427, a Phase 1 study, has completed, sponsored by Wayne State University.

COMPLETED
Registry status
Phase 1
Development phase
102 participants
Enrollment target

Study Summary

The goal of this study is to look at how a type of drug called cannabinoids are related to the processing of fear signals, the experience of emotions and fear, and the pattern of activity in the brain that is involved in these processes and how this relates to the treatment of post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder that occurs after experiencing a traumatic event(s) and is characterized by unwanted memories of the trauma(s) through flashbacks or nightmares, avoidance of situations that remind the person of the event, difficulty experiencing emotions, loss of interest in activities the person used to enjoy, and increased arousal, such as difficulty falling asleep or staying asleep, anger and hypervigilance. The information gained from this study could lead to the development of new treatments for persons who suffer from anxiety or fear-based disorders.

Primary Outcome

functional magnetic resonance imaging (fMRI) blood oxygen level-dependent (BOLD) percent signal change within region of interests \[amygdala; ventromedial prefrontal cortex; hippocampus\]

Interventions

  • DRUG Placebo capsule
  • DRUG Dronabinol 7.5 milligram oral capsule

Trial Details

FieldValue
Enrollment Target 102 participants
Start Date 2021-04-15
Est. Completion 2025-05-31
Phase Phase 1
Wayne State University

163 total trials

What the finished NCT04080427 record still lists

NCT04080427 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo capsule is the first listed.

NCT04080427 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04080427 about?

NCT04080427 is a clinical study titled "Effects of Delta9-tetrahydrocannabinol (THC) on Retention of Memory for Fear Extinction Learning in PTSD: R33 Study". The goal of this study is to look at how a type of drug called cannabinoids are related to the processing of fear signals, the experience of emotions and fear, and the pattern of activity in the brain that is involved in these processes and how this relates to the treatment of post-traumatic stress ...

What is the current status of trial NCT04080427?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 102 participants. The study started on 2021-04-15. Estimated completion is 2025-05-31.

What interventions are being tested in trial NCT04080427?

The interventions under investigation include: Placebo capsule (DRUG), Dronabinol 7.5 milligram oral capsule (DRUG).

Who is sponsoring clinical trial NCT04080427?

This trial is sponsored by Wayne State University, which has 163 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04080427's enrollment target sits among peer trials

102 543rd of 2000 higher than 1,455 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04080427, the US trial registry maintained by the National Library of Medicine. NCT04080427 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.