Clinical trial NCT05573906: Benzodiazepine Taper With Cognitive Behavioral Therapy in Patients Using Prescription Opioids
Official title: Augmenting the Efficacy of Benzodiazepine Taper With Telehealth-Delivered Cognitive Behavioral Therapy for Anxiety Disorders in Patients Using Prescription Opioids
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Boston University
First posted: 2022-10-10
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Adherence
timeFrame: at week 15
measure: Treatment Satisfaction Questionnaire
timeFrame: at week 15
measure: Timeline Followback (change in benzodiazepine and opioid use and dose)
timeFrame: Baseline, weeks 1-14, post-treatment (week 15), and 2 months from week 15
measure: Depression Anxiety and Stress Scale (change in scores over time)
timeFrame: Baseline, weeks 1-14, post-treatment (week 15), and 2 months from week 15
Secondary outcomes:
measure: Urine Drug Screen (UDS)
timeFrame: Baseline, post-treatment (week 15), and 2 months from week 15
measure: California prescription drug monitoring database (CURES)
timeFrame: Baseline, weeks 1-14, post-treatment (week 15), and 2 months from week 15
measure: Anxiety Sensitivity Index-3 (change)
timeFrame: Baseline, bi-weekly during weeks 1-14, post-treatment (week 15), and 2 months from week 15
measure: Pain Catastrophizing Scale (change)
timeFrame: Baseline, bi-weekly during weeks 1-14, post-treatment (week 15), and 2 months from week 15
Other outcomes:
Locations:
city: Burbank
country: United States
facility: UCLA Health MPTF Toluca Lake Primary Care
state: California
city: Los Angeles
country: United States
facility: UCLA Integrated Substance Abuse Programs
state: California
city: Santa Monica
country: United States
facility: UCLA Family Health Center
state: California
Study officials:
References: