Anxiety DisordersNCT05573906
Benzodiazepine Taper With Cognitive Behavioral Therapy in Patients Using Prescription Opioids
A study testing Cognitive behavioral therapy for anxiety plus benzodiazepine taper in people with Anxiety Disorders, run by University of California, Los Angeles at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Cognitive behavioral therapy for anxiety plus benzodiazepine taper
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Apr 2023to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
UCLA Health MPTF Toluca Lake Primary Care
Burbank, California, 91505
UCLA Integrated Substance Abuse Programs
Los Angeles, California, 90025
UCLA Family Health Center
Santa Monica, California, 90404
About this study
Official title: 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.
- Conditions
- Anxiety Disorders
- Being tested
- Cognitive behavioral therapy for anxiety plus benzodiazepine taper, Health education control plus benzodiazepine taper
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy for anxiety plus benzodiazepine taperCombination 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.
Health education control plus benzodiazepine taperCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Cognitive behavioral therapy for anxiety plus benzodiazepine taper |
| 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. Receives: Combination Product: Health education control plus benzodiazepine taper |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
number of sessions attended
Measured: at week 15
Treatment Satisfaction Questionnaire
This measure will be used to assess patient satisfaction and acceptability with the interventions.
Measured: 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)
Measured: 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)
Measured: Baseline, weeks 1-14, post-treatment (week 15), and 2 months from week 15
Secondary outcomes (4)
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.
Measured: Baseline, post-treatment (week 15), and 2 months from week 15
California prescription drug monitoring database (CURES)
Opioid and benzodiazepine prescriptions (including dose) will be corroborated by review of the CURES system.
Measured: 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.
Measured: 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.
Measured: Baseline, bi-weekly during weeks 1-14, post-treatment (week 15), and 2 months from week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start13 Apr 2023
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Boston University
- Responsible party
- Principal investigator, Kate Taylor, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573906
- Sponsor's protocol ID
- IRB#22-001451
- Other IDs
- R21DA053394
- Status last verified
- Sep 2025
- First submitted
- 5 Oct 2022
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 42258278Wolitzky-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.
PubMed 37730196
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting the Efficacy of Benzodiazepine Taper With Telehealth-Delivered Cognitive Behavioral Therapy for Anxiety Disorders in Patients Using Prescription Opioids
- ClinicalTrials.gov ID
- NCT05573906
- Acronym / sponsor ID
- IRB#22-001451
- Conditions
- Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Boston University
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy for anxiety plus benzodiazepine taper | Experimental | Combination Product: Cognitive behavioral therapy for anxiety plus benzodiazepine taper11 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. |
| Health education control plus benzodiazepine taper | Active comparator | Combination Product: Health education control plus benzodiazepine taper11 sessions of individual therapy control consisting of psychoeducational topics related to health and well-being, along with the gentle, 12-week benzodiazepine taper. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral therapy for anxiety plus benzodiazepine taper11 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. | Combination product | Cognitive behavioral therapy for anxiety plus benzodiazepine taper |
| Health education control plus benzodiazepine taper11 sessions of individual therapy control consisting of psychoeducational topics related to health and well-being, along with the gentle, 12-week benzodiazepine taper. | Combination product | Health education control plus benzodiazepine taper |
Primary outcome
Adherence
Time frame: at week 15
number of sessions attended
Treatment Satisfaction Questionnaire
Time frame: at week 15
This measure will be used to assess patient satisfaction and acceptability with the interventions.
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)
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)
4 secondary outcomes
Urine Drug Screen (UDS)
Time frame: 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
Anxiety Sensitivity Index-3 (change)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Derived from this study: PubMed 42258278Wolitzky-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.
- Derived from this study: PubMed 37730196Wolitzky-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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy for anxiety plus benzodiazepine taper in people with Anxiety Disorders, run by University of California, Los Angeles at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: at week 15). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05573906, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.