BioWare for AUD and PTSD

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: PTSD; Alcohol Use Disorder

Treatments: Behavioral: COPE

Study type: Interventional

Funder types: Other

Identifiers

NCT05187364

00115253

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

COPE Therapy Arm

Experimental group

Description:

Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE)

Treatment:

Behavioral: COPE