Benzodiazepine Dependence Clinical Trial
— EMPOWER-EDOfficial title:
Promoting Benzodiazepine Cessation Through an Electronically-delivered Patient Self-management Intervention
Verified date | March 2024 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 170 |
Est. completion date | September 30, 2025 |
Est. primary completion date | March 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Veterans having a VA primary care provider and taking prescribed benzodiazepines for at least 3 months - Have access to a smartphone, tablet, or computer Exclusion Criteria: - Individuals diagnosed with schizophrenia, dementia, seizure disorder, and/or spinal cord injury - Individuals receiving palliative care |
Country | Name | City | State |
---|---|---|---|
United States | VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
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 U — View Citation
Cucciare 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 controlle — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 25% Reduction in Benzodiazepine Use | This outcome reflects an individual cutting their dose of benzodiazepine medication by one quarter or more | 6 months | |
Primary | Cessation of Benzodiazepine Use | This outcome reflects an individual eliminating their benzodiazepine use from baseline to 6 month follow-up | 6 Months | |
Secondary | Anxiety | Change in anxiety from baseline will be measured using Spitzer's 7 item generalized anxiety disorder subscale. | 6 months | |
Secondary | Sleep quality | This outcome measures changes since baseline in sleep quality as assessed by the Patient-Reporter Outcomes Measurement System | 6 months | |
Secondary | Overall health and quality of life | Change since baseline in this variable will be assessed using the RAND Veterans SF-12 | 6 months | |
Secondary | Long-term Benzodiazepine cessation | Using VA databases, at 12 months the investigators will determine the proportion of individuals who stopped their benzodiazepine prescription since baseline and 6 months interviews. | 12 months | |
Secondary | Long-term Benzodiazepine reduction | Using VA databases, at 12 months the investigators will determine the proportion of individuals who reduce their benzodiazepine dose by one quarter or more since baseline and 6 months interviews. | 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT04533230 -
Prevention of Benzodiazepine Misuse in Primary Care
|
N/A | |
Completed |
NCT02127411 -
Effectiveness of Mindfulness Based Relapse Prevention for Chronic Users of Benzodiazepines
|
N/A | |
Terminated |
NCT03192514 -
Electronic Deprescribing Tool for the Prevention of PIP
|
N/A | |
Not yet recruiting |
NCT05765656 -
Effectiveness of a Joint General Practitioner-Pharmacist Intervention on Benzodiazepine Deprescribing in the Elderly
|
N/A | |
Not yet recruiting |
NCT05935553 -
Baclofen for Improving Benzodiazepine Titration in Benzodiazepine Dependence
|
Phase 2/Phase 3 | |
Completed |
NCT03937180 -
Blended Care for the Discontinuation of Benzodiazepine Use
|
N/A | |
Recruiting |
NCT02475538 -
Electroacupuncture for Tapering Off Long-term Benzodiazepine Use
|
N/A | |
Terminated |
NCT01893632 -
Gabapentin Treatment of Benzodiazepine Dependence
|
Phase 2 | |
Completed |
NCT00420771 -
Gabapentin Treatment of Benzodiazepine Abuse in Methadone Maintenance Patients
|
Phase 2 | |
Recruiting |
NCT06250842 -
Benzodiazepine Impact on Cognitive Function: fNIRs and PET/MRI Study
|
||
Completed |
NCT03971097 -
The Effect of Self-Forgiveness on Self-Stigma in Addiction.
|
N/A | |
Not yet recruiting |
NCT06359314 -
Anxiety Lowering and Deprescribing Through Emotion Regulation
|
N/A |