CompletedNot Applicable

BioWare for AUD and PTSD

United States4 participantsStarted 2022-05-05

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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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.

What they're measuring

Percentage of Participants Who Turn on and Off Equipment in 5 Minutes or Less

Timeframe: In-Session Visit (approximately 1 week from baseline)

System Usability Scale

Timeframe: Week 12

Trial details

NCT IDNCT05187364

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-20

Results submitted2023-11-09

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