Cognitive Behavioral Therapy + Benzodiazepine Taper for Anxiety

No longer recruiting at 2 trial locations
LM
KT
Overseen ByKate Taylor, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Los Angeles
Must be taking: Benzodiazepines, Opioids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks a safer way to manage anxiety for individuals using opioids and benzodiazepines. Researchers compare cognitive behavioral therapy (CBT), which changes thinking and behavior patterns, to regular health education in reducing benzodiazepine use. Participants will receive one of these therapies alongside a gradual reduction in benzodiazepine use over 12 weeks, all conducted through telehealth. The trial seeks individuals who have taken prescribed benzodiazepines and opioids for at least three months and experience significant anxiety. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to safer anxiety management strategies.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining cognitive behavioral therapy (CBT) with a gradual reduction of benzodiazepine use is generally safe and well-tolerated. Studies indicate that CBT helps individuals stop using benzodiazepines without causing serious side effects, particularly for those with anxiety disorders like panic disorder.

In one study, patients who used CBT while slowly reducing their benzodiazepine dosage effectively cut down or stopped their medication. Anxiety symptoms did not significantly increase during this process. CBT is often the first choice for treating anxiety disorders due to its safety and effectiveness.

Benzodiazepine tapering involves gradually lowering the medication dose over time to avoid withdrawal symptoms. Combining this approach with CBT can help patients manage anxiety more effectively.

Overall, research suggests that this method is not only safe but also beneficial for reducing benzodiazepine use while managing anxiety.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a unique combination approach to help people with anxiety who are trying to reduce their use of benzodiazepines. Most treatments for anxiety focus either on medication or therapy alone, but this trial combines cognitive behavioral therapy (CBT) specifically tailored to support benzodiazepine tapering. This approach is designed to help patients manage anxiety more effectively by using exposure-based CBT techniques, which aim to reduce the reliance on benzodiazepines over a 12-week period. By integrating these methods, researchers hope to find a more effective and supportive way to ease the transition off benzodiazepines while maintaining anxiety control.

What evidence suggests that this trial's treatments could be effective for anxiety?

Research has shown that cognitive behavioral therapy (CBT) is an effective treatment for anxiety disorders and can help individuals stop using benzodiazepines. In this trial, one group of participants will receive CBT combined with a gradual reduction of benzodiazepines. Studies have found that this combination leads to better outcomes than reducing the medication alone. For instance, one study discovered that more participants successfully stopped using benzodiazepines when CBT was added to their treatment plan compared to those who only reduced their dose. CBT teaches practical skills to manage anxiety, which can reduce the need for medication. Overall, CBT offers a safer and effective way for individuals to manage anxiety without relying on benzodiazepines. Another group in this trial will receive health education control sessions along with the benzodiazepine taper.23467

Are You a Good Fit for This Trial?

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.
Patients fluent in English
I am willing to reduce my use of benzodiazepines.
See 3 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
See 3 more

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

  • Cognitive behavioral therapy for anxiety plus benzodiazepine taper
  • Health education control plus benzodiazepine taper
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive behavioral therapy for anxiety plus benzodiazepine taperExperimental Treatment1 Intervention
Group II: Health education control plus benzodiazepine taperActive Control1 Intervention

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:
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Approved in European Union as Cognitive Behavioral Therapy (CBT) for Anxiety for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Boston University

Collaborator

Trials
494
Recruited
9,998,000+

Published Research Related to This Trial

In a study of 20 panic disorder patients, those who received cognitive behavior therapy alongside alprazolam tapering had better outcomes, with 9 out of 10 successfully remaining medication-free at follow-up, compared to 4 out of 10 in the drug-only group.
A key predictor of successful drug discontinuation was a reduction in anxiety sensitivity, which accurately predicted drug status in 85% of cases, highlighting the importance of addressing anxiety fears in treatment plans.
Predictors of alprazolam discontinuation with and without cognitive behavior therapy in panic disorder.Bruce, TJ., Spiegel, DA., Gregg, SF., et al.[2018]
Cognitive-behavioral therapy (CBT) is effective for treating anxiety disorders, both as a standalone treatment and in combination with benzodiazepines, showing similar or lower dropout rates compared to other therapies.
While combining CBT with benzodiazepines enhances treatment effects, discontinuing benzodiazepines can lead to reduced efficacy; thus, CBT can serve as a helpful transition during medication tapering.
Benzodiazepine use, cognitive impairment, and cognitive-behavioral therapy for anxiety disorders: issues in the treatment of a patient in need.Otto, MW., Bruce, SE., Deckersbach, T.[2022]
Cognitive Behavioral Therapy (CBT) significantly increases the likelihood of successfully discontinuing benzodiazepines (BZD) in patients with anxiety disorders, both in the short term (3 months) and long term (6 to 12 months), compared to gradual tapering alone.
The study analyzed three randomized controlled trials, showing that the combination of CBT and gradual tapering resulted in nearly double the success rate of discontinuation compared to tapering alone, indicating CBT's potential as an effective intervention for managing anxiety without long-term BZD use.
Does cognitive behavioral therapy for anxiety disorders assist the discontinuation of benzodiazepines among patients with anxiety disorders? A systematic review and meta-analysis.Takeshima, M., Otsubo, T., Funada, D., et al.[2021]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/37730196/
Augmenting the efficacy of benzodiazepine taper with ...The current study will evaluate the efficacy of augmenting BZ taper procedures with CBT for anxiety disorders that has been adapted specifically for patients ...
Efficacy of CBT for Benzodiazepine Discontinuation in ...Based on the primary outcome of successful discontinuation of BZ use, results indicate that adjunctive CBT provided additive benefits above both taper alone and ...
Benzodiazepine Taper With Cognitive Behavioral Therapy ...Cognitive behavioral therapy (CBT) is a first-line treatment for anxiety disorders, and represents a safer and more effective treatment for anxiety disorders ...
Randomized Clinical Trial of Supervised Tapering and ...RESULTS: All three interventions produced significant reductions in both the quantity (90% reduction) and frequency (80% reduction) of benzodiazepine use, and ...
Augmenting the efficacy of benzodiazepine taper with ...The current study will evaluate the efficacy of augmenting BZ taper procedures with CBT for anxiety disorders that has been adapted specifically for patients ...
Does cognitive behavioral therapy for anxiety disorders assist ...The results of this review suggest that CBT is effective for discontinuing BZD anxiolytics in the long term (6 to 12 months after the allocation), as well as in ...
Cognitive Behavioral Therapy + Benzodiazepine Taper for ...One study found that CBT helps people successfully stop using benzodiazepines, especially in those with panic disorder, and prevents the return of anxiety ...
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