Augmenting Benzodiazepine Receptor Agonist Deprescribing With Acupuncture and Yoga Among Older Adults

NCT06197243 | Completed DMC

• 2 other identifiers: 230716R24AG064025
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this 12-week study is to see if a new combination of treatments can help older adults reduce benzodiazepine or related medication use. The treatment combination consists of 1) medical provider visits to gradually reduce the medication dose over 12 weeks, 2) acupuncture treatments, and 3) private yoga classes. Participants will be offered weekly visits for 12 weeks to receive combined treatments. Participants will be provided surveys before, during, and after the study to learn about their experience of the treatments. At the end of the study, participants will be invited to participate in a focus group to learn about their experience in the study.

Conditions

Anxiety; Insomnia; Benzodiazepine; Deprescription

Outcome Measures

Primary Outcomes (1)

• BRZA dose change

  Dose of BRZA for patients will be measured at baseline, 4, 8, and 12 weeks

  Baseline to 12 weeks

Secondary Outcomes (3)

• Insomnia

  Baseline to12 weeks

• Anxiety

  Baseline to 12 weeks

• Proportion of participants whom the investigators collect primary and secondary outcomes.

  Baseline to 12 weeks

Study Arms (1)

Feasibility, Adherence and Acceptability Measure

EXPERIMENTAL

Assay of feasibility of study enrollment and feasibility of study treatments, the latter of which is measured via fidelity, adherence, and acceptability of/to treatments and interventions. Interventions administered for 12 weeks. Fidelity, adherence, and acceptability will be measured via patient survey and engagement.

Other: Acupuncture; Other: Yoga; Other: Deprescribing

Interventions

Acupuncture OTHER

Patients will receive acupuncture for 12 weeks.

Feasibility, Adherence and Acceptability Measure

Yoga OTHER

Patients will receive yoga therapy with one of three yoga instructors. Patients will remain with singular yoga instructor for duration of study. It is anticipated that patients will participate in yoga therapy for 12 weeks at home and in-clinic.

Feasibility, Adherence and Acceptability Measure

Deprescribing OTHER

Deprescribing of patients' benzodiazepine use will be monitored by psychiatric nurse. Tapering method will be followed for medication deprescription.

Feasibility, Adherence and Acceptability Measure

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• years and older
• Taking benzodiazepines or related medications (i.e. zolpidem, zopiclone, eszopiclone, zaleplon) at least 4 times in the last month
• English speaking
• Ability to understand study procedures and to comply with them for the length of the study

You may not qualify if:

• Cognitive impairment
• Drinking more than 3 alcoholic beverages per day
• Substance abuse disorder
• Uncontrolled psychiatric disorder, such as major depression or psychosis
• Inability or unwillingness of individual or legal guardian.representative to give written informed consent.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Osher Center for Integrative Health at Vanderbilt

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Interventions

Acupuncture Therapy; Yoga; Deprescriptions

Condition Hierarchy (Ancestors)

Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Mind-Body Therapies; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Drug Therapy

Study Officials

• Gurjeet Birdee

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Osher Center for Integrative Health Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 9, 2024
• Study Start: December 14, 2023
• Primary Completion: May 23, 2025
• Study Completion: May 23, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)