Cognitive Behavioral Therapy + Benzodiazepine Taper for Anxiety
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.12345
What 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.13467
Is 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.12356
Eligibility 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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a 12-week benzodiazepine taper with either CBT or health education control
Post-treatment
Assessment of benzodiazepine use, opioid use, and anxiety symptoms
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cognitive behavioral therapy for anxiety plus benzodiazepine taper
- Health education control plus benzodiazepine taper
Cognitive behavioral therapy for anxiety plus benzodiazepine taper is already approved in United States, European Union for the following indications:
- Anxiety disorders
- Anxiety disorders
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Boston University
Collaborator