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

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.

• Acupuncture (Other): Patients will receive acupuncture for 12 weeks.
• 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.
• Deprescribing (Other): Deprescribing of patients' benzodiazepine use will be monitored by psychiatric nurse. Tapering method will be followed for medication deprescription.

Primary outcomes

• BRZA Dose Change [Baseline to 12 weeks]: Dose of BRZA for patients will be measured at baseline and 12 weeks

Secondary outcomes

• Insomnia [Baseline to12 weeks]: Will use Patient Reported Outcomes Measurement Information System(PROMIS) Sleep Disturbance Computerized Adaptive Testing to assess difficulties staying and falling asleep. The minimum value is 0 and the maximum value is 100, with higher scores determining worse outcomes.
• Anxiety [Baseline to 12 weeks]: Will use Patient Reported Outcomes Measurement Information System(PROMIS) Anxiety Computerized Adaptive Testing. The minimum value is 0 and the maximum value is 100, with higher scores determining worse outcomes.
• Proportion of Participants Whom the Investigators Collect Primary and Secondary Outcomes. [Baseline to 12 weeks]: Will estimate feasibility of data collection for study measures by calculating proportion of participants whom the investigators collect primary and secondary outcomes.

Sex: All, ages: 65 Years to any, accepts healthy volunteers

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 the study

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 give written informed consent.

Participant flow

Outcome results

• BRZA Dose Change (Primary), Mean, Benzodiazepine equivalents (mg): Benzodiazepine Receptor Agonist Deprescribing With Acupuncture and Yoga -5.1 +/- 7.6
• Insomnia (Secondary), Median, Score on the scale: Benzodiazepine Receptor Agonist Deprescribing With Acupuncture and Yoga -3.0 (-5.4 to -.1)
• Anxiety (Secondary), Median, Score on a scale: Benzodiazepine Receptor Agonist Deprescribing With Acupuncture and Yoga -2.8 (-7.4 to 1.1)
• Proportion of Participants Whom the Investigators Collect Primary and Secondary Outcomes. (Secondary), Number, Percentage: Benzodiazepine Receptor Agonist Deprescribing With Acupuncture and Yoga 100

Adverse events

Time frame: Enrollment up to 12 weeks

• Study Protocol and Statistical Analysis Plan (PDF, 2023-03-21)
• Informed Consent Form (PDF, 2024-07-09)

• Gurjeet Birdee, Principal investigator, Vanderbilt University Medical Center

NIH grants: R24AG064025