| ID | Type | Description | Link |
|---|---|---|---|
| R21DA053394 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Boston University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive behavioral therapy for anxiety plus benzodiazepine taper | Experimental | 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. |
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| Health education control plus benzodiazepine taper | Active Comparator | 11 sessions of individual therapy control consisting of psychoeducational topics related to health and well-being, along with the gentle, 12-week benzodiazepine taper. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavioral therapy for anxiety plus benzodiazepine taper | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | number of sessions attended | at week 15 |
| Treatment Satisfaction Questionnaire | 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) | 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Urine Drug Screen (UDS) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Health MPTF Toluca Lake Primary Care | Burbank | California | 91505 | United States | ||
| UCLA Integrated Substance Abuse Programs |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42258278 | Derived | Wolitzky-Taylor K, Otto M, Metts A, Hanano M, Mooney LJ. A pilot randomized clinical trial evaluating the feasibility, acceptability, and preliminary efficacy of a cognitive-behavioral therapy adjunct to support benzodiazepine tapering among primary care patients coprescribed benzodiazepines and opioids. Psychol Addict Behav. 2026 Jun 8. doi: 10.1037/adb0001164. Online ahead of print. | |
| 37730196 | Derived | Wolitzky-Taylor K, Mooney LJ, Otto MW, Metts A, Parsons EM, Hanano M, Ram R. Augmenting the efficacy of benzodiazepine taper with telehealth-delivered cognitive behavioral therapy for anxiety disorders in patients using prescription opioids: A pilot randomized controlled trial. Contemp Clin Trials. 2023 Oct;133:107334. doi: 10.1016/j.cct.2023.107334. Epub 2023 Sep 18. |
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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.
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| Health education control plus benzodiazepine taper | Combination Product | 11 sessions of individual therapy control consisting of psychoeducational topics related to health and well-being, along with the gentle, 12-week benzodiazepine taper. |
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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) | 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) | 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 |
| Los Angeles |
| California |
| 90025 |
| United States |
| UCLA Family Health Center | Santa Monica | California | 90404 | United States |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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