Benzodiazepine Taper with Cognitive Behavioral Therapy in Patients Using Prescription Opioids

Last updated: November 12, 2024
Sponsor: University of California, Los Angeles
Overall Status: Active - Recruiting

Phase

N/A

Condition

Panic Disorders

Mood Disorders

Anxiety Disorders

Treatment

Health education control plus benzodiazepine taper

Cognitive behavioral therapy for anxiety plus benzodiazepine taper

Clinical Study ID

NCT05573906
IRB#22-001451
R21DA053394
  • Ages 18-85
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • taking prescribed BZs for at least 3 months prior to baseline and have a positiveUDS for BZs at baseline

  • currently experiencing significant distress or impairment due to their anxietysymptoms (i.e., score ≥ 6 on the OASIS during screening

  • have been prescribed opioids for at least 3 months for pain management and have apositive 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

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 paincondition) 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 andself-report), with the exception of intermittent cannabis use (not meeting criteriafor CUD) and use of alcohol above at-risk drinking cutoffs per US Dietary Guidelines

  • marked cognitive impairment.

Study Design

Total Participants: 54
Treatment Group(s): 2
Primary Treatment: Health education control plus benzodiazepine taper
Phase:
Study Start date:
April 13, 2023
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • UCLA Health MPTF Toluca Lake Primary Care

    Burbank, California 91505
    United States

    Active - Recruiting

  • UCLA Integrated Substance Abuse Programs

    Los Angeles, California 90025
    United States

    Active - Recruiting

  • UCLA Family Health Center

    Santa Monica, California 90404
    United States

    Active - Recruiting

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