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NCT05573906 · ClinicalTrials.gov registry record · NA
Benzodiazepine Taper With Cognitive Behavioral Therapy in Patients Using Prescription Opioids
A NA study of Anxiety Disorders, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- NA
- Development phase
- 42
- Enrollment target
- 3
- Study locations
NCT05573906: Completed NA study of Anxiety Disorders, sponsored by University of California, Los Angeles.
NCT05573906 is a NA study of Anxiety Disorders that has completed, run by University of California, Los Angeles. The registered enrollment target is 42 participants, below the 1,139-participant average among 84 other Anxiety Disorders trials with a reported enrollment target (96% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05573906, a NA study of Anxiety Disorders, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- NA
- Development phase
- 42 participants
- Enrollment target
- 3
- Study locations
Study Summary
Taking prescription opioids for pain together with benzodiazepines for the treatment of anxiety disorders is not recommended by the U.S. Food and Drug Administration (FDA) because of the elevated risk of serious complications, including fatal overdose. However, this concurrent prescription use continues to be prevalent, likely due to the high comorbidity between pain and anxiety disorders. Efforts are urgently needed to reduce benzodiazepine use among patients taking opioids. Cognitive behavioral therapy (CBT) is a first-line treatment for anxiety disorders, and represents a safer and more effective treatment for anxiety disorders compared to benzodiazepines. The proposed study aims to make minor adaptations to a CBT protocol to facilitate benzodiazepine tapering and to then conduct a 2-arm randomized clinical trial with primary care patients who receive benzodiazepine and opioid prescriptions. Participants will be randomized to receive a telehealth-delivered intervention consisting of a gentle, 12-week benzodiazepine taper (BZT) with either CBT or a health education control (HE). Participants will be assessed at baseline, several points throughout treatment, at post-treatment, and at a 2-month follow-up assessment on benzodiazepine use, opioid use, and anxiety symptoms. Should CBT + BZT outperform HE + BZT, this intervention could make a significant impact by reducing major consequences of concurrent use of opioids and benzodiazepines, including mortality.
Primary Outcome
number of sessions attended
Conditions Studied
Interventions
- COMBINATION_PRODUCT Cognitive behavioral therapy for anxiety plus benzodiazepine taper
- COMBINATION_PRODUCT Health education control plus benzodiazepine taper
Study Locations (3)
California
- UCLA Health MPTF Toluca Lake Primary Care - Burbank
- UCLA Integrated Substance Abuse Programs - Los Angeles
- UCLA Family Health Center - Santa Monica
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2023-04-13 |
| Est. Completion | 2025-07-31 |
| Phase | NA |
What the finished NCT05573906 record still lists
NCT05573906 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 1,139-participant average among 84 other Anxiety Disorders trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Anxiety Disorders appearing as the primary indexed condition, and to 2 interventions - of which Cognitive behavioral therapy for anxiety plus benzodiazepine taper is the first listed.
NCT05573906 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05573906 about?
NCT05573906 is a clinical study titled "Benzodiazepine Taper With Cognitive Behavioral Therapy in Patients Using Prescription Opioids". Taking prescription opioids for pain together with benzodiazepines for the treatment of anxiety disorders is not recommended by the U.S. Food and Drug Administration (FDA) because of the elevated risk of serious complications, including fatal overdose. However, this concurrent prescription use conti...
What is the current status of trial NCT05573906?
This trial is currently completed. It is a NA study. The enrollment target is 42 participants. The study started on 2023-04-13. Estimated completion is 2025-07-31.
What conditions does trial NCT05573906 study?
This clinical trial studies the following conditions: Anxiety Disorders.
What interventions are being tested in trial NCT05573906?
The interventions under investigation include: Cognitive behavioral therapy for anxiety plus benzodiazepine taper (COMBINATION_PRODUCT), Health education control plus benzodiazepine taper (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05573906?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05573906 being conducted?
This trial has 3 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05573906's enrollment target sits among peer trials
42 71st of 84 higher than 14 of 84 other Anxiety Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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