Cognitive Behavioral Therapy for Benzodiazepine Abuse

(CSTARS Trial)

Overseen By Brianna Wang

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Must be taking: Benzodiazepines

Disqualifiers: Severe anxiety, depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist individuals who have been using benzodiazepines (medications often prescribed for anxiety or sleep issues) long-term. It combines a gradual reduction in medication with cognitive behavioral therapy, a talk therapy that targets negative thought patterns. The goal is to determine if this approach can help individuals safely reduce their drug use. Suitable participants have been prescribed benzodiazepines by their primary care doctor at Beth Israel Deaconess Medical Center and do not exhibit severe anxiety or depression symptoms. As an unphased trial, this study provides a unique opportunity to explore new methods for managing long-term benzodiazepine use.

Will I have to stop taking my current medications?

The trial involves a benzodiazepine deprescribing intervention, which means you will likely need to reduce or stop taking your benzodiazepine medication as part of the study.

What prior data suggests that this cognitive-behavioral therapy-enhanced intervention is safe for older adults?

Research has shown that gradually reducing benzodiazepine use, combined with cognitive behavioral therapy (CBT), is generally well-tolerated by patients. Studies have found that CBT helps people reduce benzodiazepines more effectively and safely. For instance, patients often experience fewer withdrawal symptoms, such as anxiety and trouble sleeping, when CBT is part of their treatment plan.

Evidence from past research also suggests that while some risks exist, they are usually minor. Most people do not experience severe side effects during the tapering process when CBT is used. This approach supports patients both mentally and physically, aiding their adjustment as they reduce medication.

Overall, this treatment appears safe and helps people manage their medication use more effectively over time. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for benzodiazepine abuse, which often focus solely on medication tapering, this approach combines a benzodiazepine taper with Cognitive Behavioral Therapy (CBT). This dual approach is unique because it not only helps to reduce the physical dependence on the medication but also addresses the psychological aspects of addiction. Researchers are excited about this treatment because CBT can provide patients with coping strategies and behavioral changes that support long-term success, potentially enhancing the overall effectiveness of the tapering process. This integration of therapeutic techniques could lead to more comprehensive recovery outcomes for individuals struggling with benzodiazepine abuse.

What evidence suggests that this treatment might be an effective treatment for benzodiazepine abuse?

Research has shown that using Cognitive Behavioral Therapy (CBT) alongside a gradual reduction in benzodiazepine use helps many people stop taking these medications. In this trial, participants will receive a Benzodiazepine Medication Taper combined with CBT. One study found that three out of four people successfully stopped using benzodiazepines with CBT. Additionally, CBT offers benefits beyond just reducing medication use, enhancing its effectiveness. Another study reported a 90% decrease in the amount and an 80% decrease in the frequency of benzodiazepine use with CBT. Overall, combining CBT with a gradual reduction plan yields promising results in reducing dependence on benzodiazepines. ^{1 4 6 7 8}

Who Is on the Research Team?

Gloria Yeh, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for older adults (65+) who have been prescribed benzodiazepines long-term by their primary care doctors at BIDMC Healthcare Associates Clinic. It's not suitable for those whose doctors opt out or patients with severe anxiety or depression.

Inclusion Criteria

I am prescribed long-term benzodiazepines by my doctor at BIDMC.

Exclusion Criteria

Primary Care Practitioner (PCP) opt out

I am experiencing severe anxiety or depression.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a benzodiazepine tapering program enhanced with brief cognitive behavioral therapy

10 weeks

Weekly sessions

Follow-up

Participants are monitored for sustainability of benzodiazepine dose reduction and other outcomes

6 months

Electronic health record review at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Benzodiazepine Medication Taper with Cognitive Behavioral Therapy

Trial Overview

The study tests a brief cognitive-behavioral therapy program designed to help participants reduce and stop using benzodiazepine medications safely under medical supervision.

How Is the Trial Designed?

Group I: Benzodiazepine Medication Taper with Cognitive Behavioral Therapy Experimental Treatment 1 Intervention

Brief Cognitive Behavioral Therapy to Enhance Benzodiazepine Deprescribing

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of alprazolam discontinuation with and without cognitive behavior therapy in panic disorder. Bruce, TJ., Spiegel, DA., Gregg, SF., et al.[2018]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8508349/

Cognitive Behavioral Therapy and Acceptance and ...

Benzodiazepines have proven to be highly effective for treating insomnia and anxiety. Although considered safe when taken for a short period of time, ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2589979125000137

A narrative review of strategies for discontinuing long-term ...

CBT reported a high abstinence rate, with an average of three out of four people successfully discontinuing BZ use. The withdrawal program alone enabled one ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5962448/

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 ...

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psychiatryonline.org

psychiatryonline.org/doi/full/10.1176/appi.ajp.161.2.332

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 ...

5.

link.springer.com

link.springer.com/article/10.1007/s11606-025-09499-2

Joint Clinical Practice Guideline on Benzodiazepine ...

Long-term BZD use is associated with an increased risk of physical dependence and withdrawal and ongoing risk of adverse events such as falls, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12463801/

Joint Clinical Practice Guideline on Benzodiazepine Tapering

Benzodiazepine use, abuse, and dependence. J Clin Psychiatry. 2005;66 Suppl 2:28-33. [PubMed] [Google Scholar]; 21. Sun EC, Dixit A, Humphreys K, Darnall BD ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05573906

Benzodiazepine Taper With Cognitive Behavioral Therapy ...

Participants will be assessed at baseline, several points throughout treatment, at post-treatment, and at a 2-month follow-up assessment on benzodiazepine use, ...

8.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2813161

Benzodiazepine Discontinuation and Mortality Among ...

This study identifies small absolute increases in risk of harms among patients with stable long-term prescription benzodiazepine treatment who appear to ...