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

Last updated: March 19, 2024
Sponsor: Vanderbilt University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Insomnia

Treatment

Yoga

Acupuncture

Deprescribing

Clinical Study ID

NCT06197243
230716
R24AG064025
  • Ages > 65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 65 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 thestudy

Exclusion

Exclusion Criteria:

  • 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 givewritten informed consent.

Study Design

Total Participants: 30
Treatment Group(s): 3
Primary Treatment: Yoga
Phase:
Study Start date:
December 14, 2023
Estimated Completion Date:
December 14, 2024

Study Description

This study consists of a single-arm clinical study among 30 older adults taking benzodiazepine receptor antagonists (BRZA) to assess the feasibility of protocol-driven BRZA deprescribing augmented with combined acupuncture and yoga. Adults 65 years or older that are taking BRZA will be recruited. Deprescribing will be provided at weekly visits with a psychiatric nurse practitioner at the Osher Center for Integrative Health at Vanderbilt University Medical Center. Participants will receive acupuncture and yoga from a staff acupuncturist and yoga instruction from a yoga instructor at the Osher Center. Feasibility of study enrollment will occur through the study enrollment period. Feasibility of study treatments will be evaluated during and after study treatment delivery. Feasibility of study outcome assessments will occur at baseline, 4, 8, and 12 weeks. Throughout the research process, investigators will engage a Stakeholder Advisory Panel consisting of patients and clinicians.

Connect with a study center

  • Osher Center for Integrative Health at Vanderbilt

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

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