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Mitigating PTSD-CUD After Sexual Assault

Study acronym: RISE-C
StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Phase: Not applicable to Phase 1/2v7
  2. Enrollment target: 100 to 68
    • Collaborators: 1 to 5
    v6
  3. Start date: Dec 15, 2023 to Mar 14, 2024v5
  4. Primary completion date: Feb 28, 2026 to Feb 28, 2027
    • Study completion date: Feb 28, 2027 to Feb 29, 2028
    • Site contacts updated at 5 of 6 sites
    v4
  5. Primary completion date: May 2028 to Feb 28, 2026
    • Study completion date: May 2028 to Feb 28, 2027
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2023 to Dec 15, 2023
    • Study sites: 4 to 6
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05989841
Lead Sponsor University of Nevada, Las Vegas
Collaborators: University of North Carolina, Chapel Hill, National Institute on Drug Abuse (NIDA), Hennepin HART, Tulsa Police Department Forensic Nursing, SAFE Austin Harbor Shelter
Conditions
(from sponsor)		 Posttraumatic Stress Disorder, Cannabis Use Disorder
Related terms Stress Disorders, Post-Traumatic
Enrollment 68 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov