BioWare for AUD and PTSD

NCT05187364 | Completed Results DMC

• 1 other identifier: 00115253
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PTSD; Alcohol Use Disorder

Outcome Measures

Primary Outcomes (2)

• 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)

• System Usability Scale

  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.

  Week 12

Study Arms (1)

COPE Therapy Arm

EXPERIMENTAL

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

Behavioral: COPE

Interventions

COPE BEHAVIORAL

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.

COPE Therapy Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Alcoholism

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Limitations and Caveats

Limitations from this pilot trial include the small sample size, that some participants dropped out from the study without completing the full course of study treatment, and that not all participants were able (either due to study dropout or due to technological equipment failure) to complete all primary outcome assessments. As such, results should be interpreted with these limitations in mind.

Results Point of Contact

• Title: Dr. Amber Jarnecke
• Organization: Medical University of South Carolina

jarnecka@musc.edu

843-876-3115

Study Officials

• Amber M Jarnecke, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: January 11, 2022
• Study Start: May 5, 2022
• Primary Completion: February 20, 2023
• Study Completion: February 20, 2023
• Last Updated: September 24, 2024
• Results First Posted: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)