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 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.
Conditions:
🦠 Posttraumatic Stress Disorder 🦠 Cannabis Use Disorder
🗓️ Study Start (Actual) 15 December 2023
🗓️ Primary Completion (Estimated) 28 February 2026
✅ Study Completion (Estimated) 28 February 2027
👥 Enrollment (Estimated) 100
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Minneapolis, Minnesota, United States
📍 Las Vegas, Nevada, United States
📍 Chapel Hill, North Carolina, United States
📍 Smithfield, North Carolina, United States
📍 Tulsa, Oklahoma, United States
📍 Austin, Texas, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Women sexual assault survivors presenting for emergency care \<72 hours post-assault at 1 of our 4 emergency care sites
    • 2. English speakers
    • 3. 18+ years of age
    • 4. Able to provide informed consent
    • 5. Have a smartphone with continuous service \>1 year
    • 6. Report \>1x/weekly cannabis use on a substance use screener
    • 7. Report elevated AS (\>17 on the Anxiety Sensitivity Index-3)

    Exclusion Criteria:

    • 1. Inability to provide informed consent (e.g., serious injury preventing the ability to hear, speak, or see to consent and participate, or other causes (e.g., diagnosed cognitive deficits, diagnosed dementia, asleep at time of screening)).
    • 2. Prisoner
    • 3. Currently pregnant
    • 4. Lives with assailant and plans to continue to do so
    • 5. Admitted patient
    • 6. No mailing address
    • 7. Previously enrolled
    • 8. No sexual assault nurse examiner (SANE) examination
    • 9. Reporting current plan and intent for suicide or homicide
    • 10. Does not understand written and spoken English
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 10 May 2023
  • First Submitted that Met QC Criteria 10 August 2023
  • First Posted 14 August 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 21 February 2024
  • Last Update Posted 23 February 2024
  • Last Verified February 2024