CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 4 enrolled
Drug / intervention
COPEbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05187364
NCT05187364N/ACompleted

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

Medical University of South Carolina·interventional·Posted Jan 11, 2022·Updated Sep 24, 2024

In Brief

A clinical study evaluating COPE for PTSD and Alcohol Use Disorder. Completed, enrolled 4 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJan 11, 2022
Enrollment StartMay 5, 2022
Primary CompletionFeb 20, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.5 years ago

Interventions

COPEbehavioral

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.