Benzodiazepine Taper With Cognitive Behavioral Therapy in Patients Using Prescription Opioids

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Anxiety Disorders

Treatments: Combination Product: Cognitive behavioral therapy for anxiety plus benzodiazepine taper; Combination Product: Health education control plus benzodiazepine taper

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05573906

IRB#22-001451

R21DA053394 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

Cognitive behavioral therapy for anxiety plus benzodiazepine taper

Experimental group

Description:

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.

Treatment:

Combination Product: Cognitive behavioral therapy for anxiety plus benzodiazepine taper

Health education control plus benzodiazepine taper

Active Comparator group

Description:

11 sessions of individual therapy control consisting of psychoeducational topics related to health and well-being, along with the gentle, 12-week benzodiazepine taper.

Treatment:

Combination Product: Health education control plus benzodiazepine taper