Cognitive Behavioral Therapy + Benzodiazepine Taper for Anxiety
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Los Angeles
Must be taking: Benzodiazepines, Opioids
Disqualifiers: Pregnancy, Severe psychiatric symptoms, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Do I have to stop taking my current medications for this trial?
The trial requires participants to reduce their benzodiazepine use through a 12-week taper. It does not specify stopping other medications, but you must be willing to reduce benzodiazepine use.
What data supports the idea that Cognitive Behavioral Therapy + Benzodiazepine Taper for Anxiety is an effective treatment?
The available research shows that combining Cognitive Behavioral Therapy (CBT) with a benzodiazepine taper is effective for anxiety. One study found that CBT helps people successfully stop using benzodiazepines, especially in those with panic disorder, and prevents the return of anxiety symptoms. Another study showed that CBT provides additional benefits compared to just tapering off benzodiazepines or tapering with relaxation techniques. This suggests that CBT is a valuable part of the treatment, helping people manage anxiety better than other methods.
12345What safety data exists for combining CBT with benzodiazepine tapering for anxiety?
The safety and efficacy of combining cognitive behavioral therapy (CBT) with benzodiazepine tapering for anxiety have been evaluated in several studies. A pilot randomized controlled trial explored the feasibility and preliminary efficacy of CBT with benzodiazepine tapering in patients using opioids, highlighting the potential for telehealth delivery to improve adherence and access. Another study demonstrated that CBT provides significant benefits for benzodiazepine discontinuation in patients with panic disorder, showing large effect sizes compared to tapering alone or with relaxation. A systematic review and meta-analysis confirmed that CBT combined with gradual tapering significantly increases the success rate of benzodiazepine discontinuation in both short and long-term follow-ups. These findings suggest that CBT is effective and potentially safe for assisting benzodiazepine discontinuation in anxiety disorders, although further studies with larger sample sizes are needed to confirm these results.
13467Is Cognitive Behavioral Therapy plus benzodiazepine taper a promising treatment for anxiety?
Yes, combining Cognitive Behavioral Therapy (CBT) with a benzodiazepine taper is a promising treatment for anxiety. Research shows that CBT helps people successfully stop using benzodiazepines, a type of drug, and reduces anxiety symptoms. It also works well when delivered through telehealth, making it more accessible. This combination can improve treatment success compared to using benzodiazepines alone.
12356Eligibility Criteria
This trial is for adults aged 18-85 who have been taking prescribed benzodiazepines and opioids for at least 3 months, are experiencing significant anxiety (scoring ≥8 on the OASIS), speak English, can access telehealth services, and want to reduce their use of benzodiazepines. Pregnant individuals or those with severe psychiatric symptoms, certain substance use disorders, ongoing need for benzodiazepines due to medical conditions, recent use of other drugs (except limited cannabis), or marked cognitive impairment cannot participate.Inclusion Criteria
I have been on prescribed benzodiazepines for over 3 months and tested positive for them.
I am between 18 and 85 years old.
Patients fluent in English
+4 more
Exclusion Criteria
Pregnancy
I have significant memory or thinking problems.
Presence of any SUD other than tobacco use disorder, OUD (co-occurring with pain condition) or sedative/hypnotic use disorder
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo a 12-week benzodiazepine taper with either CBT or health education control
12 weeks
11 sessions (telehealth)
Post-treatment
Assessment of benzodiazepine use, opioid use, and anxiety symptoms
1 week
1 visit (telehealth)
Follow-up
Participants are monitored for safety and effectiveness after treatment
2 months
1 visit (telehealth)
Participant Groups
The study tests whether Cognitive Behavioral Therapy (CBT) combined with a gradual reduction in benzodiazepine usage over 12 weeks is more effective than just health education plus tapering off these medications. Participants will receive treatment via telehealth and be monitored throughout the process as well as after completion to assess anxiety symptoms and medication use.
2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive behavioral therapy for anxiety plus benzodiazepine taperExperimental Treatment1 Intervention
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.
Group II: Health education control plus benzodiazepine taperActive Control1 Intervention
11 sessions of individual therapy control consisting of psychoeducational topics related to health and well-being, along with the gentle, 12-week benzodiazepine taper.
Cognitive behavioral therapy for anxiety plus benzodiazepine taper is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Cognitive Behavioral Therapy (CBT) for Anxiety for:
- Anxiety disorders
🇪🇺 Approved in European Union as Cognitive Behavioral Therapy (CBT) for Anxiety for:
- Anxiety disorders
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UCLA Integrated Substance Abuse ProgramsLos Angeles, CA
UCLA Health MPTF Toluca Lake Primary CareBurbank, CA
UCLA Family Health CenterSanta Monica, CA
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Who Is Running the Clinical Trial?
University of California, Los AngelesLead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator
Boston UniversityCollaborator
References
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. [2023]The risks of concomitant benzodiazepine (BZ) and opioid use are significant. Despite the urgent need to reduce BZ use among patients taking opioids, no treatment intervention research to our knowledge has addressed treatment for this concurrent, high-risk use. The current study will evaluate the efficacy of augmenting BZ taper procedures with CBT for anxiety disorders that has been adapted specifically for patients with concomitant BZ and opioid use (either use as prescribed or misuse), a high-risk patient population. Research combining rapidly scalable behavioral interventions ancillary to pharmacological approaches delivered via telehealth in primary care settings is innovative and important given concerning trends in rising prevalence of BZ/opioid co-prescription, BZ-associated overdose deaths, and known barriers to implementation of behavioral health interventions in primary care. CBT delivery using telehealth has the potential to aid adherence and promote access and dissemination of procedures in primary care. Lastly, the current study will utilize an experimental therapeutics approach to preliminarily explore the mechanism of action for the proposed interventions. The overall aim of the present pilot randomized controlled trial is to examine the feasibility and preliminary efficacy of a BZ taper with CBT for anxiety disorders adapted for patients with concomitant BZ (BZT + CBT) and opioid use to a BZ taper with a control health education program (BZT + HE) in a sample of individuals (N = 54) who have been prescribed and are taking benzodiazepines and opioids for at least 3 months prior to baseline and experience anxious distress. Screening and outcome measures, methods, and implications are described. Trial Registration: ClinicalTrials.gov (NCT05573906).
Benzodiazepine discontinuation difficulties in panic disorder: conceptual model and outcome for cognitive-behavior therapy. [2019]There is consistent support for the efficacy of cognitive-behavior therapy (CBT) to aid the successful discontinuation of benzodiazepine (BZ) medication in patients with panic disorder, and help these individuals maintain treatment gains while off medication. In this article, we provide a conceptual model for BZ discontinuation difficulties in patients with panic disorder. Outcome studies are reviewed, and are placed in the context of other evidence for the efficacy of CBT in patients with this disorder.
Efficacy of CBT for benzodiazepine discontinuation in patients with panic disorder: Further evaluation. [2022]Despite its acute efficacy for the treatment of panic disorder, benzodiazepines (BZs) are associated with a withdrawal syndrome that closely mimics anxiety sensations, leading to difficulty with treatment discontinuation and often disorder relapse. An exposure-based cognitive-behavioral treatment for BZ discontinuation, Panic Control Treatment for BZ Discontinuation (CBT) targets the fear of these sensations and has demonstrated efficacy in preventing disorder relapse and facilitating successful BZ discontinuation among patients with panic disorder. In this randomized controlled trial, CBT was compared to taper alone and a taper plus a relaxation condition to control for the effect of therapist contact and support among 47 patients with panic disorder seeking taper from BZs. Based on the primary outcome of successful discontinuation of BZ use, results indicate that adjunctive CBT provided additive benefits above both taper alone and taper plus relaxation, with consistently medium and large effect sizes over time that reached significance at the six month follow-up evaluation. The efficacy of CBT relative to either of the other taper conditions reflected very large and significant effect sizes at that time. These findings suggest that CBT provides specific efficacy for the successful discontinuation from BZs, even when controlling for therapist contact and relaxation training.
Development and acceptability of a decision aid for anxiety disorder considering discontinuation of benzodiazepine anxiolytic. [2023]We aimed to develop a decision aid (DA) for individuals with anxiety disorders who consider tapering benzodiazepine (BZD) anxiolytics, and if tapering, tapering BZD anxiolytics with or without cognitive behavioral therapy (CBT) for anxiety. We also assessed its acceptability among stakeholders.
Benzodiazepine use, cognitive impairment, and cognitive-behavioral therapy for anxiety disorders: issues in the treatment of a patient in need. [2022]Cognitive-behavioral therapy (CBT) is effective in the treatment of anxiety disorders when used in conjunction with benzodiazepine pharmacotherapy and when used as a monotherapy. Patients using CBT alone have dropout rates similar to or lower than those patients undergoing other forms of therapy, including benzodiazepines. CBT also works well with patients who do not respond adequately to pharmacotherapy. Combined CBT and benzodiazepine treatment has additive effects when compared with benzodiazepine monotherapy; however, patients receiving combined therapy who subsequently discontinue benzodiazepine treatment experience a loss of efficacy compared with CBT and placebo, perhaps due to fear extinction being context dependent. To avoid this loss of efficacy, CBT may be administered alone or as a bridge between benzodiazepine use and discontinuation during a medication taper. The case report upon which this supplement is based questions the value of CBT for patients experiencing cognitive impairment due to an anxiety disorder, benzodiazepine medication, substance abuse, or a combination of these factors. This article addresses this concern and asserts that CBT is a valuable treatment option in these cases.
Predictors of alprazolam discontinuation with and without cognitive behavior therapy in panic disorder. [2018]In a previous paper the authors reported survival data for 20 panic disorder patients whose therapeutic doses of alprazolam were tapered by one of two methods: slow, flexible drug taper with supportive medical management or the same taper procedure carried out concurrently with cognitive behavior therapy. This report is an analysis of predictors of drug discontinuation success in that study. In addition, between-group comparisons of clinical measures at follow-up are presented.
Does cognitive behavioral therapy for anxiety disorders assist the discontinuation of benzodiazepines among patients with anxiety disorders? A systematic review and meta-analysis. [2021]Long-term use of benzodiazepines (BZD) is not recommended for the treatment of anxiety disorders. Cognitive behavioral therapy (CBT) is an effective treatment option for discontinuation of BZD in patients with anxiety disorders. This systematic review and meta-analysis sought to clarify whether CBT is effective for discontinuing BZD anxiolytics in patients with anxiety disorders. This study was preregistered with PROSPERO (registration number: CRD42019125263). A literature search of major electronic databases was conducted in December 2018. Three randomized controlled trials were included in this review, and meta-analyses were performed. The proportion of discontinuing BZD anxiolytics was significantly higher in the CBT plus gradual tapering group than in the gradual tapering alone group, both in the short term (3 months after allocation; number needed to treat: 3.2, 95% confidence interval [CI]: 2.1 to 7.1; risk ratio: 1.96, 95%CI: 1.29 to 2.98, P = 0.002, three studies) and long term (6 to 12 months after allocation; number needed to treat: 2.8, 95%CI: 1.9 to 5.3; risk ratio: 2.16, 95%CI: 1.41 to 3.32, P = 0.0004, three studies). CBT may be effective for discontinuing BZD anxiolytics, both in the short term and in the long term after the allocation. Further studies with larger sample sizes are necessary to draw definitive conclusions regarding the efficacy and safety of CBT for discontinuing BZD anxiolytics in patients with anxiety disorders.