BioWare for AUD and PTSD

Alcohol Use Disorder Clinical Trial

Official title:

BioWare to Enhance Treatment for Alcohol Use Disorder and Posttraumatic Stress Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05187364
• Other study ID #: 00115253
• Status: Completed
• Phase: N/A
• Start date: May 5, 2022
• Est. completion date: February 20, 2023

Study information

• Verified date: April 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: February 20, 2023
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• PTSD

Intervention

Behavioral:
• COPE
The COPE therapy is a talk-therapy in which individuals are asked about their trauma, alcohol use, mood, and behavior. The therapy occurs over 12 sessions and will be paired with a telehealth technology system to determine if it enhances the COPE therapy. The telehealth system is worn on the arm and hand during the out-of-office COPE homework assignments. It consists of a small camera (about the size of a pencil eraser), Bluetooth earpiece with microphone, monitors to measure and record heart rate and skin conductance, and a breathalyzer to assess blood alcohol content. The device will connect to an application on password protected cell phone that will monitor and record the above listed information as well as reported subjective units of distress and craving. A study coach will virtually guide participants through one out-of-office assignment per week using this technology. Interviews and surveys will be collected at study baseline and weekly during treatment.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants who turn on and off equipment in 5 minutes or less	Feasibility is 80% of participants turning on and off equipment in 5 minutes or less	In-Session Visit (approximately 1 week from baseline)
Primary	Mean score of System Usability Scale	Acceptability is mean score of 68 or greater on System Usability Scale	Week 12