What is the mechanism of action of this treatment?

The most common treatments for Benzodiazepine Addiction include pharmacological and behavioral interventions. Pharmacologically, long-acting benzodiazepines like diazepam are used to taper off the drug gradually, reducing withdrawal symptoms and the risk of relapse. Flumazenil, a benzodiazepine receptor antagonist, can help manage acute withdrawal symptoms but is limited to inpatient settings. Phenobarbital has also been used historically but carries safety concerns. Behavioral interventions, such as cognitive-behavioral therapy (CBT), focus on changing the thought patterns and behaviors associated with benzodiazepine use. These interventions are crucial as they address both the physical dependence and the psychological aspects of addiction, providing a comprehensive approach to treatment. The self-help app being studied aims to facilitate CBT, making it more accessible and potentially more effective for patients seeking to reduce or cease benzodiazepine use.

What side effects are associated with this type of intervention?

The most common treatments for benzodiazepine addiction include cognitive-behavioral therapy (CBT) and gradual tapering of the medication. Side effects of tapering can include withdrawal symptoms such as anxiety, concentration difficulties, appetite changes, palpitations, restlessness, headache, tremor, and sweating. Behavioral interventions like CBT are generally well-tolerated but may initially increase anxiety as patients confront their fears without the aid of medication. Adjunctive pharmacologic treatments, such as the use of antidepressants or mood stabilizers, can have their own side effects, including gastrointestinal disturbances, sleep issues, and mood changes.

What prior FDA approvals exist?

There are no specific FDA-approved medications for the treatment of benzodiazepine addiction. However, behavioral interventions, such as cognitive-behavioral therapy (CBT) and self-help strategies, have shown promise. The self-help app being studied is an example of a behavioral intervention aimed at reducing benzodiazepine use. These approaches focus on gradually tapering the medication and providing psychological support to manage withdrawal symptoms and prevent relapse.

What other types of research exist?

Promising alternatives to a self-help app for reducing benzodiazepine use include cognitive-behavioral therapy (CBT) alone or combined with a slow-tapering approach.

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EMPOWER-ED App for Benzodiazepine Withdrawal (EMPOWER-ED Trial)

N/A

Waitlist Available

Led By Keith N. Humphreys, PhD MA

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Veterans having a VA primary care provider and taking prescribed benzodiazepines for at least 3 months

Must not have

Individuals diagnosed with seizure disorder

Individuals receiving palliative care

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests an app called EMPOWER-ED designed to help Veterans reduce or stop using anxiety medications like Ativan and Xanax. The app offers step-by-step support to taper off these drugs safely. Researchers hope it will improve health outcomes and reduce risks associated with long-term use of these medications.

Who is the study for?

This trial is for veterans who have been prescribed benzodiazepines (like Ativan or Xanax) for at least 3 months and have a VA primary care provider. Participants must be able to use a smartphone, tablet, or computer. It's not open to individuals with schizophrenia, dementia, seizure disorders, spinal cord injuries, or those receiving palliative care.

What is being tested?

The study tests an app called EMPOWER-ED designed to help veterans reduce or stop using benzodiazepines. The app is based on a self-help packet that has previously helped people quit these medications. Veterans will use the app on their devices as part of the intervention.

What are the potential side effects?

Since this trial involves a self-management intervention through an app rather than medication, traditional side effects are not expected. However, participants may experience anxiety or discomfort while reducing benzodiazepine usage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a veteran with a VA primary care provider and have been prescribed benzodiazepines for over 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with a seizure disorder.

Select...

I am receiving care focused on relieving symptoms.

Select...

I have been diagnosed with a spinal cord injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

25% Reduction in Benzodiazepine Use

Cessation of Benzodiazepine Use

Secondary study objectives

Anxiety

Long-term Benzodiazepine cessation

Long-term Benzodiazepine reduction

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: EMPOWER-EDExperimental Treatment1 Intervention

Individuals will be given access on their preferred platform to an electronic self-help app focused on reducing benzodiazepine use

Group II: ControlActive Control1 Intervention

Individuals will be provided care as usual

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Benzodiazepine Addiction include pharmacological and behavioral interventions. Pharmacologically, long-acting benzodiazepines like diazepam are used to taper off the drug gradually, reducing withdrawal symptoms and the risk of relapse. Flumazenil, a benzodiazepine receptor antagonist, can help manage acute withdrawal symptoms but is limited to inpatient settings. Phenobarbital has also been used historically but carries safety concerns. Behavioral interventions, such as cognitive-behavioral therapy (CBT), focus on changing the thought patterns and behaviors associated with benzodiazepine use. These interventions are crucial as they address both the physical dependence and the psychological aspects of addiction, providing a comprehensive approach to treatment. The self-help app being studied aims to facilitate CBT, making it more accessible and potentially more effective for patients seeking to reduce or cease benzodiazepine use.

Substance use disorders: realizing the promise of pharmacogenomics and personalized medicine.Hypnotic taper with or without self-help treatment of insomnia: a randomized clinical trial.[Evaluation of a program to help discontinuation of benzodiazepines].