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Can therapy replace risky anxiety pills for patients on opioids?

NCT ID NCT05573906

Symptom relief Sponsor: University of California, Los Angeles Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether adding cognitive behavioral therapy (CBT) to a gradual benzodiazepine taper helps patients with anxiety who also take prescription opioids reduce their benzodiazepine use. 42 primary care patients were randomly assigned to receive either CBT or a health education control alongside a 12-week taper. The goal was to see if CBT improves adherence, satisfaction, and reduces benzodiazepine and opioid use while managing anxiety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cognitive behavioral therapy plus benzodiazepine taper
What this could lead to
If it works, this could provide a safer way for patients with anxiety and chronic pain to reduce their benzodiazepine use while managing anxiety effectively.
What could go wrong
This is a small, early-stage study with only 42 participants, so results may not apply to everyone. The intervention requires active participation and may not work for all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

42 people

The number who actually took part.

Started

Apr 2023

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * taking prescribed BZs for at least 3 months prior to baseline and have a positive UDS for BZs at baseline * currently experiencing significant distress or impairment due to their anxiety symptoms (i.e., score ≥ 6 on the OASIS during screening * have been prescribed opioids for at least 3 months for pain management and have a positive UDS for prescribed opioids at baseline * are between 18-85 years old * are fluent in English * have access to a digital device with internet access for telehealth * are willing to reduce BZ use. Exclusion Criteria: * pregnancy * psychiatric symptoms requiring a higher level of care (i.e., severe suicidality, manic or psychotic symptoms not stabilized on medication) * presence of any SUD other than tobacco use disorder, OUD (co-occurring with pain condition) or sedative/hypnotic use disorder) * medical conditions that require ongoing treatment with benzodiazepines (e.g., certain seizure disorders) * use of drugs other than BZs and opioids in the past 30 days (as indicated by UDS and self-report), with the exception of intermittent cannabis use (not meeting criteria for CUD) and use of alcohol above at-risk drinking cutoffs per US Dietary Guidelines * marked cognitive impairment.

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Conditions

The condition(s) this trial relates to.

anxiety disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anxiety disorders

Contacts and locations

Locations

  • UCLA Family Health Center

    Santa Monica, California, 90404, United States

  • UCLA Health MPTF Toluca Lake Primary Care

    Burbank, California, 91505, United States

  • UCLA Integrated Substance Abuse Programs

    Los Angeles, California, 90025, United States

More trials for these conditions

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