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Benzodiazepine Taper With Cognitive Behavioral Therapy in Patients Using Prescription Opioids
NCT05573906 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05573906
The ClinicalTrials.gov registry entry for NCT05573906 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 829 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05573906 reports 3 study locations spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05573906?
This trial is sponsored by University of California, Los Angeles, which has 829 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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