PTSDNCT05187364

BioWare for AUD and PTSD

A study testing COPE in people with PTSD and Alcohol Use Disorder, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: PTSD, Alcohol Use Disorder
What is being tested?: COPE
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 1 siteUnited States
Study dates: 5 May 2022to 20 Feb 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical University of South Carolina
Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: BioWare to Enhance Treatment for Alcohol Use Disorder and Posttraumatic Stress Disorder

Conditions: PTSD, Alcohol Use Disorder
Being tested: COPE
Medical subject headings: Stress Disorders, Post-Traumatic, Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

COPEBehavioural
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.

Study groups in NCT05187364
Study group	Role	What they receive
COPE Therapy Arm	Experimental	Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE) Receives: Behavioral: COPE

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 May 202220 Feb 2023

First posted11 Jan 2022
Study start5 May 2022
Primary completion20 Feb 2023
Study completion20 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PTSDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05187364
Sponsor's protocol ID: 00115253
Status last verified: Sep 2024
First submitted: 28 Dec 2021
Last updated: 24 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All PTSD trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BioWare to Enhance Treatment for Alcohol Use Disorder and Posttraumatic Stress Disorder
ClinicalTrials.gov ID: NCT05187364
Acronym / sponsor ID: 00115253
Conditions: PTSD, Alcohol Use Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 4 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Study start: 5 May 2022 (actual)
Primary completion: 20 Feb 2023 (actual)
Study completion: 20 Feb 2023 (actual)
First posted: 11 Jan 2022 (actual)
Results: Posted 24 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
COPE Therapy Arm	Experimental	Behavioral: COPEConcurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE)

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
COPEThe 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.	Behavioural	COPE Therapy Arm

Primary outcome

Percentage of Participants Who Turn on and Off Equipment in 5 Minutes or Less
Time frame: In-Session Visit (approximately 1 week from baseline)
Feasibility is 80% of participants turning on and off equipment in 5 minutes or less
System Usability Scale
Time frame: Week 12
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.

Results and safety

Results posted to the registry on 24 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
COPE Therapy Arm	4	1

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

Time frame: In-Session Visit (approximately 1 week from baseline). Count of participants. Unit: Participants

Measure	COPE Therapy Arm n = 2
Value	2

Population analysed: Two enrolled participant completed this assessment.

Primary outcome: System Usability Scale

Time frame: Week 12. Mean (Standard Deviation). Unit: units on a scale

Measure	COPE Therapy Arm n = 2
Value	90.00 (7.07)

Population analysed: Two enrolled participants completed this assessment.

Adverse events

Time frame: Adverse event data were collected for each participant over the course of their COPE therapy treatment (i.e., up to 12 session that could take place over 6 months).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
COPE Therapy Arm	0 of 4 (0%)	1 of 4 (25%)	0 of 4

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amber M Jarnecke, PhD principal investigator

Medical University of South Carolina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing COPE in people with PTSD and Alcohol Use Disorder, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Turn on and Off Equipment in 5 Minutes or Less (time frame: In-Session Visit (approximately 1 week from baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05187364.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024; AzTrials last refreshed its copy on 30 Oct 2026.