NCT05187364

BioWare for AUD and PTSD

Completed NA Results posted Last updated 24 September 2024

What this trial tests

NA trial testing COPE in PTSD in 4 participants. Completed in 20 February 2023.

Timeline

5 May 2022

Primary endpoint
20 February 2023

20 February 2023

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	5 May 2022
Primary completion	20 February 2023
Estimated completion	20 February 2023
Sites	1 location across United States

Drugs / interventions tested

• COPE — full drug profile →

Conditions studied

• PTSD — all drugs for PTSD →
• Alcohol Use Disorder — all drugs for Alcohol Use Disorder →

Sponsor

Medical University of South Carolina

Who can join

Adults 18 to 70, any sex, with PTSD or Alcohol Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Who Turn on and Off Equipment in 5 Minutes or Less Primary · In-Session Visit (approximately 1 week from baseline)

Feasibility is 80% of participants turning on and off equipment in 5 minutes or less

Group	Value	95% CI
COPE Therapy Arm	2

System Usability Scale Primary · Week 12

The System Usability Scale measures how usable and acceptable a product is. This scale ranges from 0-100 with higher scores being indicative of greater usability/acceptability. A mean score of 68 or greater is considered acceptable.

Group	Value	95% CI
COPE Therapy Arm	90.00	± 7.07

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected for each participant over the course of their COPE therapy treatment (i.e., up to 12 session that could take place over 6 months).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

COPE Therapy Arm

Serious: 0/4 (0%)

Deaths: 0/4

Other adverse events (3 terms — click to expand)

Reaction	System	COPE Therapy Arm
Common Cold	Infections and infestations	—
Stomach bug	Infections and infestations	—
COVID-19	Infections and infestations	—

Data from ClinicalTrials.gov NCT05187364 adverse events section.

Sponsor's own description

This study examines the ability of an innovative telehealth technology system to enhance Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE) talk-therapy for individuals with posttraumatic stress disorder (PTSD) and alcohol use disorder.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.