- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05573906
Benzodiazepine Taper With Cognitive Behavioral Therapy in Patients Using Prescription Opioids
March 4, 2024 updated by: Kate Taylor, University of California, Los Angeles
Augmenting the Efficacy of Benzodiazepine Taper With Telehealth-Delivered Cognitive Behavioral Therapy for Anxiety Disorders 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 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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kate Taylor, PhD
- Phone Number: 13102480645
- Email: kbtaylor@mednet.ucla.edu
Study Contact Backup
- Name: Larissa Mooney, MD
- Email: lmooney@mednet.ucla.edu
Study Locations
-
-
California
-
Burbank, California, United States, 91505
- Recruiting
- UCLA Health MPTF Toluca Lake Primary Care
-
Contact:
- Reuben J Ram, MD
-
Los Angeles, California, United States, 90025
- Recruiting
- UCLA Integrated Substance Abuse Programs
-
Contact:
- Maria Hanano
- Email: mhanano@mednet.ucla.edu
-
Contact:
- Kate Taylor
- Email: kbtaylor@mednet.ucla.edu
-
Santa Monica, California, United States, 90404
- Recruiting
- UCLA Family Health Center
-
Contact:
- Michelle A Bholat
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive behavioral therapy for anxiety plus benzodiazepine taper
11 sessions of individual therapy consisting of exposure-based cognitive behavioral therapy that is designed specifically for assisting with benzodiazepine taper.
This will be added to a gentle, 12-week benzodiazepine taper.
CBT will be initiated for two sessions prior to the benzodiazepine taper initiation.
|
11 sessions of individual therapy consisting of exposure-based cognitive behavioral therapy that is designed specifically for assisting with benzodiazepine taper.
This will be added to a gentle, 12-week benzodiazepine taper.
CBT will be initiated for two sessions prior to the benzodiazepine taper initiation.
|
Active Comparator: Health education control plus benzodiazepine taper
11 sessions of individual therapy control consisting of psychoeducational topics related to health and well-being, along with the gentle, 12-week benzodiazepine taper.
|
11 sessions of individual therapy control consisting of psychoeducational topics related to health and well-being, along with the gentle, 12-week benzodiazepine taper.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence
Time Frame: at week 15
|
number of sessions attended
|
at week 15
|
Treatment Satisfaction Questionnaire
Time Frame: at week 15
|
This measure will be used to assess patient satisfaction and acceptability with the interventions.
|
at week 15
|
Timeline Followback (change in benzodiazepine and opioid use and dose)
Time Frame: Baseline, weeks 1-14, post-treatment (week 15), and 2 months from week 15
|
Timeline Followback (TLFB) will be used to assess BZ use and dose, opioid use and dose, and other substance use (and frequency and quantity).
BZ dose at each assessment period will be assessed via self-report.
Data will be gathered with the Timeline Followback (TLFB62), and facilitated by a dose diary card that patients will be given to track substance use (i.e., days of use of each drug including BZs) and dose of BZ on each day of BZ use.
The diary card will only be used as a tool for participant recall during the TLFB administration, and will not be collected as data.
TLFB administration will also be enhanced by asking patients to show their BZ pill bottles TLFB will be used to document self-reported use of substances for each day since the last TLFB assessment during the acute treatment phase (i.e., past 7 days during weekly study visits) and in the past 30 days for baseline, post-treatment, and follow-up (past month)
|
Baseline, weeks 1-14, post-treatment (week 15), and 2 months from week 15
|
Depression Anxiety and Stress Scale (change in scores over time)
Time Frame: Baseline, weeks 1-14, post-treatment (week 15), and 2 months from week 15
|
Primary outcome measure to assess anxiety symptoms (anxiety subscale will be primary; depression and stress subscales will be examined as secondary)
|
Baseline, weeks 1-14, post-treatment (week 15), and 2 months from week 15
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urine Drug Screen (UDS)
Time Frame: Baseline, post-treatment (week 15), and 2 months from week 15
|
UDS panel will include benzodiazepines, opiates, buprenorphine, and oxycodone at baseline and follow-up; UDS will also test for other substances including cocaine, amphetamines, and THC.
|
Baseline, post-treatment (week 15), and 2 months from week 15
|
California prescription drug monitoring database (CURES)
Time Frame: Baseline, weeks 1-14, post-treatment (week 15), and 2 months from week 15
|
Opioid and benzodiazepine prescriptions (including dose) will be corroborated by review of the CURES system.
|
Baseline, weeks 1-14, post-treatment (week 15), and 2 months from week 15
|
Anxiety Sensitivity Index-3 (change)
Time Frame: Baseline, bi-weekly during weeks 1-14, post-treatment (week 15), and 2 months from week 15
|
The ASI-3 measures anxiety sensitivity (cognitive misappraisals of anxiety as being harmful, or "fear of fear.").
ASI-3 will be given frequently throughout treatment to establish temporal precedence needed to assess for possible mediation of treatment outcomes.
|
Baseline, bi-weekly during weeks 1-14, post-treatment (week 15), and 2 months from week 15
|
Pain Catastrophizing Scale (change)
Time Frame: Baseline, bi-weekly during weeks 1-14, post-treatment (week 15), and 2 months from week 15
|
The Pain Catastrophizing Scale will be used as a secondary outcome associated with opioid prescription use and will be given frequently throughout treatment to establish temporal precedence needed to assess for possible mediation of treatment outcomes.
|
Baseline, bi-weekly during weeks 1-14, post-treatment (week 15), and 2 months from week 15
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 13, 2023
Primary Completion (Estimated)
August 30, 2024
Study Completion (Estimated)
August 30, 2024
Study Registration Dates
First Submitted
October 5, 2022
First Submitted That Met QC Criteria
October 6, 2022
First Posted (Actual)
October 10, 2022
Study Record Updates
Last Update Posted (Actual)
March 6, 2024
Last Update Submitted That Met QC Criteria
March 4, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB#22-001451
- R21DA053394 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Per NIH guidelines, we provide a data sharing plan for the study.
The study MPIs will collaborate with the NIH to finalize public use dataset procedures, ensure that the rights and privacy of all individual research participants are protected at all times, and that Protected Personal Health Information (PHI) is protected as required by law and approved by the study IRBs.
We will share our data via National Institute of Health Data Archive (NDA).
NDA links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technology.
We will use these technologies to submit data to NDA.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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