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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to conduct a single-arm pilot trial of a brief cognitive-behavioral therapy-enhanced benzodiazepine deprescribing intervention in 20 older adults (aged ≥55 years) prescribed chronic benzodiazepines by their primary care clinicians.

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 data supports the effectiveness of the treatment Benzodiazepine Medication Taper with Cognitive Behavioral Therapy for benzodiazepine abuse?

Research shows that combining cognitive behavioral therapy (CBT) with a gradual reduction of benzodiazepine use helps more people stop using the drug compared to tapering alone. In one study, nearly 75% of patients who received CBT with tapering stopped using benzodiazepines, compared to 37% who did not receive CBT. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy for Benzodiazepine Abuse safe for humans?

Cognitive Behavioral Therapy (CBT) combined with benzodiazepine tapering has been studied in various conditions and is generally considered safe for humans. Studies show that CBT can help reduce benzodiazepine use without significant safety concerns, even in older adults and those with anxiety disorders. ^{1 3 6 7 8}

How does the treatment of Benzodiazepine Medication Taper with Cognitive Behavioral Therapy differ from other treatments for benzodiazepine abuse?

This treatment is unique because it combines a gradual reduction of benzodiazepine use with cognitive behavioral therapy (CBT), which helps patients develop coping strategies and improve self-efficacy, making it more effective for long-term discontinuation compared to tapering alone. ^{1 3 6 9 10}

Research Team

Gloria Yeh, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Discontinuation of benzodiazepines among older insomniac adults treated with cognitive-behavioural therapy combined with gradual tapering: a randomized trial. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Treatment of out-patients with complicated benzodiazepine dependence: comparison of two approaches. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Benzodiazepine discontinuation among adults with GAD: A randomized trial of cognitive-behavioral therapy. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Pharmacological interventions for benzodiazepine discontinuation in chronic benzodiazepine users. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of supervised tapering and cognitive behavior therapy to facilitate benzodiazepine discontinuation in older adults with chronic insomnia. [2018]

6. United States 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Interventions to improve benzodiazepine tapering success in the elderly: a systematic review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Predictors of alprazolam discontinuation with and without cognitive behavior therapy in panic disorder. [2018]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Tapering off benzodiazepines in long-term users: an economic evaluation. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Cognitive-behavioural, pharmacological and psychosocial predictors of outcome during tapered discontinuation of benzodiazepine. [2018]