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EMPOWER-ED App for Benzodiazepine Withdrawal (EMPOWER-ED Trial)

N/A

Waitlist Available

Led By Keith N. Humphreys, PhD MA

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Veterans having a VA primary care provider and taking prescribed benzodiazepines for at least 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

EMPOWER-ED Trial Summary

This trial is studying a self-help packet turned app to help Veterans stop taking benzodiazepines, which are prescribed to treat anxiety and sleeping difficulties but have risks of physical dependence and other problems when used long-term.

Who is the study for?

This trial is for veterans who have been prescribed benzodiazepines (like Ativan or Xanax) for at least 3 months and have a VA primary care provider. Participants must be able to use a smartphone, tablet, or computer. It's not open to individuals with schizophrenia, dementia, seizure disorders, spinal cord injuries, or those receiving palliative care.Check my eligibility

What is being tested?

The study tests an app called EMPOWER-ED designed to help veterans reduce or stop using benzodiazepines. The app is based on a self-help packet that has previously helped people quit these medications. Veterans will use the app on their devices as part of the intervention.See study design

What are the potential side effects?

Since this trial involves a self-management intervention through an app rather than medication, traditional side effects are not expected. However, participants may experience anxiety or discomfort while reducing benzodiazepine usage.

EMPOWER-ED Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a veteran with a VA primary care provider and have been prescribed benzodiazepines for over 3 months.

EMPOWER-ED Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

25% Reduction in Benzodiazepine Use

Cessation of Benzodiazepine Use

Secondary outcome measures

Anxiety

Long-term Benzodiazepine cessation

Long-term Benzodiazepine reduction

+2 more

EMPOWER-ED Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: EMPOWER-EDExperimental Treatment1 Intervention

Individuals will be given access on their preferred platform to an electronic self-help app focused on reducing benzodiazepine use

Group II: ControlActive Control1 Intervention

Individuals will be provided care as usual

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,433 Total Patients Enrolled

Keith N. Humphreys, PhD MAPrincipal InvestigatorVA Palo Alto Health Care System, Palo Alto, CA

1 Previous Clinical Trials

138 Total Patients Enrolled

Michael A Cucciare, PhDPrincipal InvestigatorCentral Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

3 Previous Clinical Trials

445 Total Patients Enrolled

Media Library

EMPOWER-ED Clinical Trial Eligibility Overview. Trial Name: NCT04572750 — N/A

Benzodiazepine Addiction Research Study Groups: EMPOWER-ED, Control

Benzodiazepine Addiction Clinical Trial 2023: EMPOWER-ED Highlights & Side Effects. Trial Name: NCT04572750 — N/A

EMPOWER-ED 2023 Treatment Timeline for Medical Study. Trial Name: NCT04572750 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the principal objective of this research?

"This 6-month clinical trial is focused on the cessation of benzodiazepine use. Its secondary targets include long-term benzodiazepine discontinuation, dose reduction, and general health & quality of life improvements as measured by RAND Veterans SF-12 scores."

Answered by AI

Is this research endeavor still taking on new participants?

"Clinicaltrials.gov reports that, as of June 13th 2022, this trial is not presently enrolling patients. Although in the past it was posted and later edited on June 1st, there are two other trials actively searching for candidates at this moment in time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Promoting Benzodiazepine Cessation Through an Electronically-delivered Patient Self-management Intervention

2022. "Promoting Benzodiazepine Cessation Through an Electronically-delivered Patient Self-management Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04572750.

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