Benzodiazepine Taper With Telehealth-Delivered Cognitive Behavioral Therapy for Patients Using Prescription Opioids

Last updated: April 25, 2023
Sponsor: University of California, Los Angeles
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Pain

Opioid Use Disorder

Treatment

Health Education

Benzodiazepine Taper

Cognitive Behavioral Therapy (CBT)

Clinical Study ID

NCT05845606
R21DA053394-01A1
  • Ages 18-85
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The study aims to examine the efficacy of a telehealth-delivered cognitive behavioral therapy (CBT) + benzodiazepine taper (BZ-TP) program in facilitating reductions in benzodiazepine use among patients who are prescribed opioids for pain.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have been taking prescribed BZs for at least 3 months prior to baseline and have apositive UDS for BZs at baseline;
  • Currently experience significant distress or impairment due to their anxiety symptoms (i.e., score ≥ 8 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
  • Between 18-85 years old
  • Fluent in English
  • Have access to a digital device with internet access for telehealth.
  • Willing to reduce BZ use.

Exclusion

Exclusion Criteria:

  • Pregnancy
  • Psychiatric symptoms requiring a higher level of care (i.e., severe suicidality, manicor psychotic symptoms not stabilized on medication, presence of any SUD other thantobacco use disorder, OUD (co-occurring with pain condition) or sedative/hypnotic usedisorder)
  • Medical conditions that require ongoing treatment with benzodiazepines (e.g., certainseizure 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)
  • Use of alcohol above at-risk drinking cutoffs per US Dietary Guidelines
  • Marked cognitive impairment

Study Design

Total Participants: 54
Treatment Group(s): 3
Primary Treatment: Health Education
Phase:
Study Start date:
January 31, 2023
Estimated Completion Date:
November 30, 2023

Study Description

This study will examine the efficacy of adding a cognitive behavioral therapy (CBT) program developed and evaluated for patients with anxiety disorders to a benzodiazepine (BZ) taper as an augmentation strategy to improve the success of benzodiazepine reduction among patients taking concurrent opioid prescriptions for pain. There is a high risk of mortality including fatal overdose among patients taking opioids and BZs, yet it remains a prevalent problem. Treating underlying anxiety contributing to BZ use and potentially implicated in pain has the potential to decrease BZ use and possibly reduce opioid use. Thus, the current study moves the field forward in testing the efficacy of a combined CBT + BZ taper compared to the BZ taper plus a health education control condition. All interventions will be delivered via telehealth to patients recruited from a primary care clinic, where BZ and opioid co-prescribing is common and primary care providers may lack the tools and resources to effectively taper their patients off BZs.

Participants who are co-prescribed benzodiazepines and opioids and report elevated anxiety symptoms will be randomized to one of two conditions: (1) BZ taper with telehealth delivered CBT to facilitate taper; (2) BZ taper with health education control. Participants will be assessed on anxiety symptoms, BZ use/dose, opioids use/dose at baseline, post-treatment, and at a 2-month follow-up.

Connect with a study center

  • UCLA Health MPTF Toluca Lake Primary Care Clinic

    Burbank, California 91505
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.