Reducing benzodiazepine use in patients taking prescription opioids through therapy

Augmenting the Efficacy of Benzodiazepine Taper with Telehealth-Delivered Cognitive Behavioral Therapy for Anxiety Disorders in Patients Using Prescription Opioids

This study is testing a new therapy to help people who are taking prescription opioids and benzodiazepines safely reduce their benzodiazepine use while managing anxiety.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: University of California, Los Angeles (Academic / other)
• Locations: 3 sites (Burbank, California and 2 other locations)
• Trial ID: NCT05573906 on ClinicalTrials.gov

What this trial studies

This study aims to address the concurrent use of benzodiazepines and prescription opioids, which poses significant health risks. It will adapt a cognitive behavioral therapy (CBT) protocol to assist patients in tapering off benzodiazepines while managing anxiety disorders. Participants will be randomly assigned to receive either the adapted CBT intervention or a health education control, both alongside a benzodiazepine taper. The study will utilize telehealth to deliver the interventions, making it accessible to patients in primary care settings.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-85 who have been prescribed both benzodiazepines and opioids for at least three months and are experiencing significant anxiety symptoms.

Not a fit: Patients who are pregnant, have severe psychiatric symptoms requiring higher-level care, or have medical conditions necessitating ongoing benzodiazepine treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risks associated with benzodiazepine use in patients on opioids while effectively managing their anxiety.

How similar studies have performed: Other studies have shown promise in using cognitive behavioral therapy for anxiety management, but this specific approach to tapering benzodiazepines in opioid users is relatively novel.

Eligibility criteria

Inclusion Criteria:

* taking prescribed BZs for at least 3 months prior to baseline and have a positive UDS for BZs at baseline
* currently experiencing significant distress or impairment due to their anxiety symptoms (i.e., score ≥ 6 on the OASIS during screening
* have been prescribed opioids for at least 3 months for pain management and have a positive UDS for prescribed opioids at baseline
* are between 18-85 years old
* are fluent in English
* have access to a digital device with internet access for telehealth
* are willing to reduce BZ use.

Exclusion Criteria:

* pregnancy
* psychiatric symptoms requiring a higher level of care (i.e., severe suicidality, manic or psychotic symptoms not stabilized on medication)
* presence of any SUD other than tobacco use disorder, OUD (co-occurring with pain condition) or sedative/hypnotic use disorder)
* medical conditions that require ongoing treatment with benzodiazepines (e.g., certain seizure disorders)
* use of drugs other than BZs and opioids in the past 30 days (as indicated by UDS and self-report), with the exception of intermittent cannabis use (not meeting criteria for CUD) and use of alcohol above at-risk drinking cutoffs per US Dietary Guidelines
* marked cognitive impairment.

Where this trial is running

Burbank, California and 2 other locations

• UCLA Health MPTF Toluca Lake Primary Care — Burbank, California, United States (Recruiting)
• UCLA Integrated Substance Abuse Programs — Los Angeles, California, United States (Recruiting)
• UCLA Family Health Center — Santa Monica, California, United States (Recruiting)

Study contacts

• Study coordinator: Kate Taylor, PhD

Conditions Anxiety Disorders