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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Anxiety Disorders; Substance Use Disorders
• Intervention / Treatment: Behavioral: Benzodiazepine Taper; Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Health Education

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Larissa Mooney, MD; Email: lmooney@mednet.ucla.edu
• Study Contact Backup: Name: Kate Taylor-Wolitzky, PhD; Phone Number: 3102069391; Email: kbtaylor@mednet.ucla.edu

Study Locations

• United States
  • California
    • Burbank, California, United States, 91505
      • Recruiting
      • UCLA Health MPTF Toluca Lake Primary Care Clinic
      • Contact: Reuben Ram, MD; Email: rram@mednet.ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Have been taking prescribed BZs for at least 3 months prior to baseline and have a positive 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 a positive 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 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)
• Use of alcohol above at-risk drinking cutoffs per US Dietary Guidelines
• Marked cognitive impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT + BZ-TP; Participants in this condition will receive telehealth-delivered Cognitive Behavioral Therapy (CBT) in addition to the benzodiazepine taper (BZ-TP) treatment.	Behavioral: Benzodiazepine Taper; The BZ-TP is a 14-week intervention that assists participants in reducing their benzodiazepine prescription through a gradual taper at approximately 10%-20% reduction per week for a total of 12 weeks. Dose reduction will be recommended but not required. This intervention is identical in both arms.; Behavioral: Cognitive Behavioral Therapy (CBT); The telehealth delivered CBT is an 11-week intervention that includes psychoeducation, interoceptive exposure, somatic skills, and cognitive restructuring.
Active Comparator: HE + BZ-TP; Participants in this condition will receive telehealth-delivered health education in addition to the benzodiazepine taper (BZ-TP) treatment.	Behavioral: Benzodiazepine Taper; The BZ-TP is a 14-week intervention that assists participants in reducing their benzodiazepine prescription through a gradual taper at approximately 10%-20% reduction per week for a total of 12 weeks. Dose reduction will be recommended but not required. This intervention is identical in both arms.; Behavioral: Health Education; The Health Education (HE) intervention will include 11 weeks of an interactive health education program to match for therapy time. The HE is a published multimedia program addressing various health, wellness and lifestyle topics such as nutrition, dental care, immunizations, health screening, smoking, and time management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timeline Followback	Assesses for change in benzodiazepine use frequency and dose across study duration	Baseline, Weekly for the duration of treatment (up to 20 weeks), post-treatment (at 20 weeks post baseline), and at 2-month follow-up
Depression, Anxiety, & Stress Scale	Assesses for change in anxiety symptom severity across study duration	Baseline, Weekly for the duration of treatment (up to 20 weeks), post-treatment (at 20 weeks post baseline), and at 2-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety Sensitivity Index	Used to assess for change in anxiety sensitivity across the duration of the study as a secondary outcome and potential treatment mediator	Baseline, Bi-weekly for the duration of treatment (up to 20 weeks), post-treatment (at 20 weeks post baseline), and at 2-month follow-up
Pain Catastrophizing Scale	Assesses for change in pain catastrophizing across the duration of the study as a secondary outcome related to opioid use, which will also be examined as a potential mediator of treatment outcome	Baseline, Bi-weekly for the duration of treatment (up to 20 weeks), post-treatment (at 20 weeks post baseline), and at 2-month follow-up
Timeline Followback	Assesses changes in opioid use and dose across study duration	Baseline, Weekly for the duration of treatment (up to 20 weeks), post-treatment (at 20 weeks post baseline), and at 2-month follow-up

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: Boston University; UCLA Health MPTF Toluca Lake Primary Care Clinic

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2023
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): November 30, 2023

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Estimate): May 5, 2023

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Telehealth; Cognitive Behavioral Therapy; Opioids; Benzodiazepine Taper
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Pain; Neurologic Manifestations; Substance-Related Disorders; Disease; Chronic Pain; Anxiety Disorders
• Other Study ID Numbers: R21DA053394-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be made available upon request by a researcher, after discussion of the planned analyses with the Principal investigators

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No