100 Participants Needed

Digital Therapeutics for PTSD and Cannabis Use Disorder

(RISE-C Trial)

Recruiting at 5 trial locations
NA
Overseen ByNicole A Short, PhD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Nevada, Las Vegas
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the digital therapeutic treatment for PTSD and cannabis use disorder safe for humans?

Relaxation techniques, including those used in digital therapeutics, have been studied for conditions like PTSD and panic disorder, showing mild therapeutic effects without significant adverse events. However, when cannabis formulations are involved, common side effects include dry mouth, drowsiness, and fatigue, especially with THC.12345

How is the RISE Guide treatment for PTSD and Cannabis Use Disorder different from other treatments?

The RISE Guide treatment is unique because it focuses on digital therapeutic methods like relaxation techniques and stress management, which are non-drug approaches, unlike cannabis-based therapies that involve using cannabis compounds. This treatment offers a novel way to manage symptoms without the use of cannabis, which is often used in other PTSD treatments.46789

What data supports the effectiveness of the treatment Relaxation Control, Relaxation Techniques, Stress Management, Anxiety Reduction Methods, RISE Guide for PTSD and Cannabis Use Disorder?

Research shows that relaxation techniques can help reduce anxiety, which is a common issue in PTSD. A study found that relaxation therapy led to improvements in anxiety and depression, suggesting it might be helpful for managing PTSD symptoms.36101112

Are You a Good Fit for This Trial?

This trial is for English-speaking women over 18 who have experienced a sexual assault within the last 72 hours and are seeking emergency care. They must use cannabis more than once weekly, have high anxiety sensitivity, own a smartphone with service for over a year, and be able to consent. Exclusions include living with the assailant, being an admitted patient or prisoner, cognitive impairments preventing informed consent, current pregnancy, no fixed address or prior enrollment.

Inclusion Criteria

Able to provide informed consent
Have a smartphone with continuous service >1 year
Report >1x/weekly cannabis use on a substance use screener
See 2 more

Exclusion Criteria

Prisoner
Previously enrolled
No sexual assault nurse examiner (SANE) examination
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a digital therapeutic intervention targeting anxiety sensitivity and PTSD-CUD risk, including a 3-week cognitive behavioral intervention followed by 6 weeks of ecological momentary intervention

9 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of PTSD symptoms, anxiety, depression, and cannabis use

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Relaxation Control
  • RISE Guide
Trial Overview The study tests a new digital therapeutic called RISE Guide against Relaxation Control to prevent PTSD-CUD in women after sexual assault. It aims to evaluate user acceptability and effectiveness of these interventions in reducing PTSD-CUD risk among survivors presenting at emergency care sites.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: RISE GuideExperimental Treatment1 Intervention
Group II: RelaxationActive Control1 Intervention

Relaxation Control is already approved in United States, European Union for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Relaxation Control for:
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Relaxation Techniques for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Nevada, Las Vegas

Lead Sponsor

Trials
81
Recruited
14,700+

University of North Carolina, Chapel Hill

Collaborator

Trials
1,588
Recruited
4,364,000+

Published Research Related to This Trial

A 28-year-old female with complex D-PTSD experienced a remarkable 98.5% reduction in dissociative symptoms after 10 sessions of cannabis-assisted psychotherapy (CAP) over 5 months, indicating strong efficacy for this novel treatment.
The patient not only no longer met the criteria for D-PTSD but also reported sustained improvements for over 2 years, suggesting that CAP may offer long-lasting benefits similar to those seen with classic psychedelics.
Cannabis-assisted psychotherapy for complex dissociative posttraumatic stress disorder: A case report.Ragnhildstveit, A., Kaiyo, M., Snyder, MB., et al.[2023]
In a study of 114 veterans undergoing cognitive processing therapy for PTSD, cannabis users initially reported higher PTSD symptom severity than nonusers, but both groups showed similar treatment outcomes after therapy.
The findings suggest that stopping cannabis use during treatment may lead to comparable improvements in PTSD symptoms for both cannabis users and nonusers, although further research is needed to assess long-term effects and the impact of resumed cannabis use.
Residential PTSD treatment outcomes during cognitive processing therapy for veterans with and without recent histories of cannabis use.Hale, AC., Bremer-Landau, J., Wright, TP., et al.[2021]
In a study of 23 subjects with panic disorder, diazepam was the only treatment that produced significant physiological changes, indicating its efficacy in reducing anxiety symptoms.
Relaxation therapy showed the largest improvements in self-reported anxiety and depression, suggesting it may be a beneficial approach for managing general anxiety in panic disorder, even though these changes were not statistically significant.
A controlled comparison of relaxation and diazepam in panic disorder.Taylor, CB., Kenigsberg, ML., Robinson, JM.[2013]

Citations

Cannabis-assisted psychotherapy for complex dissociative posttraumatic stress disorder: A case report. [2023]
Residential PTSD treatment outcomes during cognitive processing therapy for veterans with and without recent histories of cannabis use. [2021]
A controlled comparison of relaxation and diazepam in panic disorder. [2013]
Microcomputer-assisted relaxation. [2008]
Relaxation training for anxiety: a ten-years systematic review with meta-analysis. [2022]
Nature videos for PTSD: protocol for a mixed-methods feasibility study. [2022]
The efficacies of three relaxation regimens in the treatment of PTSD in Vietnam War veterans. [2019]
The impact of PTSD clusters on cannabis use in a racially diverse trauma-exposed sample: An analysis from ecological momentary assessment. [2020]
The Effectiveness and Adverse Events of Cannabidiol and Tetrahydrocannabinol Used in the Treatment of Anxiety Disorders in a PTSD Subpopulation: An Interim Analysis of an Observational Study. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
The Long-Term, Prospective, Therapeutic Impact of Cannabis on Post-Traumatic Stress Disorder. [2023]
Short and Long-Term Effects of Cannabis on Symptoms of Post-Traumatic Stress Disorder. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Cannabis update: Anxiety disorders and post-traumatic stress disorder. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity