N/A Completed N=4 Treatment

BioWare for AUD and PTSD

Post-Traumatic Stress Disorder · Alcohol Use Disorder

Source: ClinicalTrials.gov NCT05187364 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2024

Primary outcomePrimary: Percentage of Participants Who Turn on and Off Equipment in 5 Minutes or Less — 2 Participants

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Who Turn on and Off Equipment in 5 Minutes or Less	2	—
PRIMARY System Usability Scale	90.00	—

Eligibility Criteria

Inclusion Criteria

Male or female; aged 18-70 years.
Able to provide written informed consent.
Meet DSM-5 diagnostic criteria for current moderate to severe alcohol use disorder.
Meet DSM-5 diagnostic criteria for current PTSD.
Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 4 weeks before study initiation.

Exclusion Criteria

Meet DSM-5 criteria for a history of or current psychotic or bipolar disorders.
Current suicidal or homicidal ideation and intent.
Psychotropic medications which have been initiated during the past 4 weeks.
Acute alcohol withdrawal.
Pregnancy or breastfeeding for people of childbearing potential.
Currently enrolled in evidence based behavioral treatment for AUD or PTSD.
Implanted electronic devices of any kind, including pacemakers, electronic infusion pumps, stimulators, defibrillators or similar.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05187364). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.