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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2025-09-23
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Registry facts
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Interventions
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 control consisting of psychoeducational topics related to health and well-being, along with the gentle, 12-week benzodiazepine taper.
Eligibility
primary outcomes
Time frame: at week 15
number of sessions attended
Time frame: at week 15
This measure will be used to assess patient satisfaction and acceptability with the interventions.
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)
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)
secondary outcomes
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.
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.
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.
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.
Publications
No exact PMID-linked public article is currently readable locally.