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NCT05989841 · ClinicalTrials.gov registry record · Phase 1
Mitigating PTSD-CUD After Sexual Assault
A Phase 1 study of Post Traumatic Stress Disorder and Cannabis Use Disorder, sponsored by University of Nevada, Las Vegas.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
- 6
- Study locations
NCT05989841: Recruiting Phase 1 study of Post Traumatic Stress Disorder and Cannabis Use Disorder, sponsored by University of Nevada, Las Vegas.
NCT05989841 is a Phase 1 study of Post Traumatic Stress Disorder and Cannabis Use Disorder that is actively recruiting participants, run by University of Nevada, Las Vegas. The registered enrollment target is 68 participants, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (90% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05989841, a Phase 1 study of Post Traumatic Stress Disorder and Cannabis Use Disorder, is actively recruiting participants, sponsored by University of Nevada, Las Vegas.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
- 6
- Study locations
Study Summary
683,000 women are sexually assaulted annually in the United States, half of whom develop chronic posttraumatic stress disorder (PTSD) and thus have markedly increased risk for cannabis use disorder (CUD). The current proposal will test the acceptability, initial efficacy, and mechanisms underlying a novel digital therapeutic targeting risk for PTSD-CUD, which could address the critical need for PTSD-CUD prevention for the 100,000 women who annually present for emergency care after sexual assault. In this research context, the applicant will receive key training in multisite, emergency-care based randomized clinical trials (RCTs), advanced statistical analyses for RCTs and ecological momentary assessment data, biobehavioral mechanisms underlying PTSD-CUD prevention, and professional development, launching her independent research career focused on reducing the public health burden of PTSD-CUD among sexual assault survivors by leveraging digital therapeutics.
Primary Outcome
18-item self-report measure of anxiety sensitivity assessing all three subdomains of anxiety sensitivity (physical, cognitive, social). Participants respond to 18 items (e.g., It scares me when my heart beats rapidly) on a 4-point Likert scale. Scores range from 0-72, with higher scores indicating higher levels of anxiety sensitivity.
Conditions Studied
Interventions
- BEHAVIORAL RISE Guide
- BEHAVIORAL Relaxation Control
Study Locations (6)
North Carolina
- UNC Chapel Hill - Chapel Hill
- Harbor Shelter - Smithfield
Minnesota
- Hennepin Assault Response Team - Minneapolis
Nevada
- University Medical Center - Las Vegas
Oklahoma
- Tulsa Forensic Nursing - Tulsa
Texas
- SAFE Austin - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2024-03-14 |
| Est. Completion | 2028-02-29 |
| Phase | Phase 1 |
What NCT05989841 shows while recruiting
NCT05989841 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which RISE Guide is the first listed.
NCT05989841 lists 6 locations in 5 states (North Carolina, Minnesota, Nevada).
Frequently Asked Questions
What is clinical trial NCT05989841 about?
NCT05989841 is a clinical study titled "Mitigating PTSD-CUD After Sexual Assault". 683,000 women are sexually assaulted annually in the United States, half of whom develop chronic posttraumatic stress disorder (PTSD) and thus have markedly increased risk for cannabis use disorder (CUD). The current proposal will test the acceptability, initial efficacy, and mechanisms underlying a...
What is the current status of trial NCT05989841?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2024-03-14. Estimated completion is 2028-02-29.
What conditions does trial NCT05989841 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder, Cannabis Use Disorder.
What interventions are being tested in trial NCT05989841?
The interventions under investigation include: RISE Guide (BEHAVIORAL), Relaxation Control (BEHAVIORAL).
Who is sponsoring clinical trial NCT05989841?
This trial is sponsored by University of Nevada, Las Vegas, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05989841 being conducted?
This trial has 6 study locations across Minnesota, Nevada, North Carolina, Oklahoma, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05989841's enrollment target sits among peer trials
68 154th of 262 higher than 109 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder 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.
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