Taking Benzodiazepines for Any Reason for 3 MonthsEMPOWER-EDNCT04572750
Promoting Benzodiazepine Cessation Through an Electronically-delivered Patient Self-management Intervention
A study testing EMPOWER-ED in people with Taking Benzodiazepines for Any Reason for 3 Months and Benzodiazepine Dependence, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Benzodiazepines (e.g., Ativan, Xanax) are widely prescribed medications that are used mainly to treat anxiety and sleeping difficulties. Long-term use of benzodiazepine carries risks of physical dependence, addiction, falls and other accidents, and problems in thinking/concentrating. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Taking Benzodiazepines for Any Reason for 3 Months, Benzodiazepine Dependence
- What is being tested?
- EMPOWER-ED
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 3 Jul 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Veterans having a VA primary care provider and taking prescribed benzodiazepines for at least 3 months
- Have access to a smartphone, tablet, or computer
Who cannot join
- Individuals diagnosed with schizophrenia, dementia, seizure disorder, and/or spinal cord injury
- Individuals receiving palliative care
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
About this study
Benzodiazepines (e.g., Ativan, Xanax) are widely prescribed medications that are used mainly to treat anxiety and sleeping difficulties. Long-term use of benzodiazepine carries risks of physical dependence, addiction, falls and other accidents, and problems in thinking/concentrating. Researchers in Canada developed a printed self-help packet that enabled many individuals to reduce or cease taking benzodiazepines on their own. This study is designed to tailor that packet to the Veteran population, convert it to an app that people can use on their laptop or smart phone, and test whether the app helps promote benzodiazepine prescribing.
Read the detailed description
Background: Long-term use of benzodiazepine medication has been increasing sharply inside and outside of VA, raising the risk of cognitive decline, falls, and overdose among patients. A self-directed benzodiazepine tapering intervention known as EMPOWER was shown effective in a non-VA clinical trial, and within VA there is significant interest in tailoring it to and providing it for Veterans. Significance: Although often useful as short-term medications, when taken for extended periods benzodiazepines carry risk of cognitive decline and other brain damage, falls and other accidents, benzodiazepine dependence and opioid-benzodiazepine overdose (VA Pharmacy Benefits Management Academic Detailing Service, 2017). This is major concern within VA, which prescribes benzodiazepines to over 350,000 Veterans a year, 2/3 of whom take them long-term (i.e., 3 months or more) (VA Pharmacy Benefits Management Academic Detailing Service, 2017). Innovation: Because the EMPOWER intervention was paper-and-pencil based, it would be useful to convert it to an electronic version that worked on smart phones, tablets, and/or desktop computers. Accordingly, the proposed project intends to convert EMPOWER to electronic format and to tailor it to the needs and preferences of the Veteran population. Specific Aims: Aim 1: Tailor a promising non-VA benzodiazepine cessation intervention (EMPOWER) to Veterans and simultaneously convert it from paper-and-pencil to electronic format. Aim 2: Conduct a randomized clinical trial of the effectiveness of the tailored, electronic intervention (EMPOWER-ED) on VA primary care patients' benzodiazepine cessation/reduction and functional outcomes. Aim 3: Conduct a budget impact analysis to estimate the costs of implementing the EMPOWER-ED throughout VA. Methodology: This conversion and tailoring will be an iterative process that the project team will conduct via focus groups comprising Veterans, VA primary care providers, and VA operational partners. When the revised intervention, called EMPOWER-ED (for EMPOWER "Electronically Delivered"), is fully designed and has been successfully beta-tested by Veterans, its effectiveness will be evaluated in a randomized clinical trial with 170 Veterans who have been on benzodiazepines for at least 3 months. The primary hypothesis of the study is that those receiving EMPOWER-ED will be significantly more likely than controls to cease benzodiazepines entirely, and, to reduce their dose by at least 25%, at 6-month follow-up. The secondary hypothesis is that Veterans receiving EMPOWER-ED will also experience fewer anxiety symptoms, better sleep quality, and overall health/quality of life at 6-month follow-up. A supplemental analysis of benzodiazepine use only will be conducted using VA databases at 12 months to evaluate whether changes identified at 6 months persist over time. The VA operational partners of the project team (Pharmacy Benefits Management, Psychotropic Drug Safety Initiative, and Office of Connected Care) are committed to disseminating EMPOWER-ED if it proves successful. Therefore, a third aim of the study is to undertake a budget impact analysis to determine what the costs would be to implement EMPOWER-ED in the VA systemwide. Next Steps/Implementation: Because electronically-delivered interventions are inexpensive to disseminate once they have been developed, this project has an excellent chance to promote health care value by creating an easily scaled-up, method of reducing the prevalence of a widespread risk to Veterans' health.
- Being tested
- EMPOWER-ED
- Keywords
- insomnia, anxiety, benzodiazepine, self-help, patient education, electronic intervention
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMPOWER-EDBehavioural
An electronic app that runs on a variety of platforms and provides education and tools designed to promote self-driven reduction of benzodiazepines.
| Study group | Role | What they receive |
|---|---|---|
| EMPOWER-ED | Experimental | Individuals will be given access on their preferred platform to an electronic self-help app focused on reducing benzodiazepine use Receives: Behavioral: EMPOWER-ED |
| Control | No intervention | Individuals will be provided care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
25% Reduction in Benzodiazepine Use
This outcome reflects an individual cutting their dose of benzodiazepine medication by one quarter or more
Measured: 6 months
Cessation of Benzodiazepine Use
This outcome reflects an individual eliminating their benzodiazepine use from baseline to 6 month follow-up
Measured: 6 Months
Secondary outcomes (3)
Anxiety
Anxiety at baseline and 6-month follow-up will be measured using Spitzer's 7 item generalized anxiety disorder subscale. The minimum and the maximum of the measure are 0 and 21 respectively with higher score representing anxiety symptoms occurred more frequently.
Measured: Baseline, 6 months
Sleep Quality
This outcome measures sleep quality as assessed by the Patient-Reporter Outcomes Measurement System. The minimum and the maximum of the measure are 8 and 40 respectively with higher score representing worse quality of sleep.
Measured: Baseline, 6 months
Overall Health and Quality of Life
Overall health and quality of life (Physical Component Summary and Mental Component Summary) will be assessed using the RAND Veterans SF-12. The minimum and the maximum of the physical component summary measure are 8.66 and 64.91 respectively with higher score representing better physical functioning. The minimum and the maximum of the mental component summary measure are 14.91 and 70.61 respectively with higher score representing better mental functioning.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 Jun 2022
- Primary completion3 Jul 2024
- Study completion3 Jul 2024
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Taking Benzodiazepines for Any Reason for 3 MonthsStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The EMPOWER-ED intervention is an app that runs on a smart phone or computer. It will provide education about the risk of benzodiazepine, a tool to create a method of self-tapering, and information on how to succeed at reducing or quitting benzodiazepine use. Individuals in the treatment condition of the trial will be given access to EMPOWER-ED on any platform they wish to use.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Keith N. Humphreys, PhD MA, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CAMichael A Cucciare, PhD, Principal investigator, Central Arkansas Veterans Healthcare System , Little Rock, AR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572750
- Sponsor's protocol ID
- IIR 18-026
- Acronym
- EMPOWER-ED
- Status last verified
- Jan 2026
- First submitted
- 20 Aug 2020
- Last updated
- 23 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cucciare MA, Abraham TH, Kemp L, White P, Marchant K, Hagedorn HJ, Humphreys K. Adapting the Eliminating Medications Through Patient Ownership of End Results Protocol to Promote Benzodiazepine Cessation Among US Military Veterans: Focus Group Study With US Military Veterans and National Veterans Health Administration Leaders. J Med Internet Res. 2022 Sep 19;24(9):e35514. doi: 10.2196/35514.
PubMed 36121697Cucciare MA, Hagedorn HJ, Bounthavong M, Abraham TH, Greene CJ, Han X, Kemp L, Marchant K, White P, Humphreys K. Promoting benzodiazepine cessation through an electronically-delivered patient self-management intervention (EMPOWER-ED): Randomized controlled trial protocol. Contemp Clin Trials Commun. 2022 Sep 5;29:100994. doi: 10.1016/j.conctc.2022.100994. eCollection 2022 Oct.
PubMed 36111174Humphreys K, Hagedorn H, Han X, Kemp L, Poitra N, Cucciare MA. Electronic Intervention for Patient-Managed Benzodiazepine Tapering: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2551807. doi: 10.1001/jamanetworkopen.2025.51807.
PubMed 41533380
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Benzodiazepine Cessation Through an Electronically-delivered Patient Self-management Intervention
- ClinicalTrials.gov ID
- NCT04572750
- Acronym / sponsor ID
- EMPOWER-ED / IIR 18-026
- Keywords
- insomnia, anxiety, benzodiazepine, self-help, patient education, electronic intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 3 Jul 2024 (actual)
- First posted
- 1 Oct 2020 (actual)
- Results
- Posted 23 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Benzodiazepines (e.g., Ativan, Xanax) are widely prescribed medications that are used mainly to treat anxiety and sleeping difficulties. Long-term use of benzodiazepine carries risks of physical dependence, addiction, falls and other accidents, and problems in thinking/concentrating. Researchers in Canada developed a printed self-help packet that enabled many individuals to reduce or cease taking benzodiazepines on their own. This study is designed to tailor that packet to the Veteran population, convert it to an app that people can use on their laptop or smart phone, and test whether the app helps promote benzodiazepine prescribing.
Detailed description
Background: Long-term use of benzodiazepine medication has been increasing sharply inside and outside of VA, raising the risk of cognitive decline, falls, and overdose among patients. A self-directed benzodiazepine tapering intervention known as EMPOWER was shown effective in a non-VA clinical trial, and within VA there is significant interest in tailoring it to and providing it for Veterans. Significance: Although often useful as short-term medications, when taken for extended periods benzodiazepines carry risk of cognitive decline and other brain damage, falls and other accidents, benzodiazepine dependence and opioid-benzodiazepine overdose (VA Pharmacy Benefits Management Academic Detailing Service, 2017). This is major concern within VA, which prescribes benzodiazepines to over 350,000 Veterans a year, 2/3 of whom take them long-term (i.e., 3 months or more) (VA Pharmacy Benefits Management Academic Detailing Service, 2017). Innovation: Because the EMPOWER intervention was paper-and-pencil based, it would be useful to convert it to an electronic version that worked on smart phones, tablets, and/or desktop computers. Accordingly, the proposed project intends to convert EMPOWER to electronic format and to tailor it to the needs and preferences of the Veteran population. Specific Aims: Aim 1: Tailor a promising non-VA benzodiazepine cessation intervention (EMPOWER) to Veterans and simultaneously convert it from paper-and-pencil to electronic format. Aim 2: Conduct a randomized clinical trial of the effectiveness of the tailored, electronic intervention (EMPOWER-ED) on VA primary care patients' benzodiazepine cessation/reduction and functional outcomes. Aim 3: Conduct a budget impact analysis to estimate the costs of implementing the EMPOWER-ED throughout VA. Methodology: This conversion and tailoring will be an iterative process that the project team will conduct via focus groups comprising Veterans, VA primary care providers, and VA operational partners. When the revised intervention, called EMPOWER-ED (for EMPOWER "Electronically Delivered"), is fully designed and has been successfully beta-tested by Veterans, its effectiveness will be evaluated in a randomized clinical trial with 170 Veterans who have been on benzodiazepines for at least 3 months. The primary hypothesis of the study is that those receiving EMPOWER-ED will be significantly more likely than controls to cease benzodiazepines entirely, and, to reduce their dose by at least 25%, at 6-month follow-up. The secondary hypothesis is that Veterans receiving EMPOWER-ED will also experience fewer anxiety symptoms, better sleep quality, and overall health/quality of life at 6-month follow-up. A supplemental analysis of benzodiazepine use only will be conducted using VA databases at 12 months to evaluate whether changes identified at 6 months persist over time. The VA operational partners of the project team (Pharmacy Benefits Management, Psychotropic Drug Safety Initiative, and Office of Connected Care) are committed to disseminating EMPOWER-ED if it proves successful. Therefore, a third aim of the study is to undertake a budget impact analysis to determine what the costs would be to implement EMPOWER-ED in the VA systemwide. Next Steps/Implementation: Because electronically-delivered interventions are inexpensive to disseminate once they have been developed, this project has an excellent chance to promote health care value by creating an easily scaled-up, method of reducing the prevalence of a widespread risk to Veterans' health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The EMPOWER-ED intervention is an app that runs on a smart phone or computer. It will provide education about the risk of benzodiazepine, a tool to create a method of self-tapering, and information on how to succeed at reducing or quitting benzodiazepine use. Individuals in the treatment condition of the trial will be given access to EMPOWER-ED on any platform they wish to use.
| Arm | Type | Receives |
|---|---|---|
| EMPOWER-ED | Experimental | Behavioral: EMPOWER-EDIndividuals will be given access on their preferred platform to an electronic self-help app focused on reducing benzodiazepine use |
| Control | No intervention | –Individuals will be provided care as usual |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Veterans having a VA primary care provider and taking prescribed benzodiazepines for at least 3 months
- Have access to a smartphone, tablet, or computer
Key exclusion criteria (2 listed)
- Individuals diagnosed with schizophrenia, dementia, seizure disorder, and/or spinal cord injury
- Individuals receiving palliative care
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 |
|---|---|---|
| EMPOWER-EDAn electronic app that runs on a variety of platforms and provides education and tools designed to promote self-driven reduction of benzodiazepines. | Behavioural | EMPOWER-ED |
Primary outcome
25% Reduction in Benzodiazepine Use
Time frame: 6 months
This outcome reflects an individual cutting their dose of benzodiazepine medication by one quarter or more
Cessation of Benzodiazepine Use
Time frame: 6 Months
This outcome reflects an individual eliminating their benzodiazepine use from baseline to 6 month follow-up
3 secondary outcomes
Anxiety
Time frame: Baseline, 6 months
Sleep Quality
Time frame: Baseline, 6 months
Overall Health and Quality of Life
Time frame: Baseline, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36121697Cucciare MA, Abraham TH, Kemp L, White P, Marchant K, Hagedorn HJ, Humphreys K. Adapting the Eliminating Medications Through Patient Ownership of End Results Protocol to Promote Benzodiazepine Cessation Among US Military Veterans: Focus Group Study With US Military Veterans and National Veterans Health Administration Leaders. J Med Internet Res. 2022 Sep 19;24(9):e35514. doi: 10.2196/35514.
- Results publication: PubMed 36111174Cucciare MA, Hagedorn HJ, Bounthavong M, Abraham TH, Greene CJ, Han X, Kemp L, Marchant K, White P, Humphreys K. Promoting benzodiazepine cessation through an electronically-delivered patient self-management intervention (EMPOWER-ED): Randomized controlled trial protocol. Contemp Clin Trials Commun. 2022 Sep 5;29:100994. doi: 10.1016/j.conctc.2022.100994. eCollection 2022 Oct.
- Derived from this study: PubMed 41533380Humphreys K, Hagedorn H, Han X, Kemp L, Poitra N, Cucciare MA. Electronic Intervention for Patient-Managed Benzodiazepine Tapering: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2551807. doi: 10.1001/jamanetworkopen.2025.51807.
- Individual participant dataSharing planned: No
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.
Keith N. Humphreys, PhD MA principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
Michael A Cucciare, PhD principal investigator
Central Arkansas Veterans Healthcare System , Little Rock, AR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMPOWER-ED in people with Taking Benzodiazepines for Any Reason for 3 Months and Benzodiazepine Dependence, run by VA Office of Research and Development 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 2 inclusion and 2 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 23 Jan 2026. 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 23 May 2025). 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?
25% Reduction in Benzodiazepine Use (time frame: 6 months). 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 NCT04572750, which also lists 3 linked publications.
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 23 Jan 2026.