Clinical trial NCT06197243: Augmenting Benzodiazepine Receptor Agonist Deprescribing With Acupuncture and Yoga Among Older Adults
Official title: Augmenting Benzodiazepine Receptor Agonist Deprescribing With Acupuncture and Yoga
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Insomnia
Benzodiazepine
Deprescription
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-01-09
Enrollment: 23
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: BRZA dose change
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Insomnia
timeFrame: Baseline to12 weeks
measure: Anxiety
timeFrame: Baseline to 12 weeks
measure: Proportion of participants whom the investigators collect primary and secondary outcomes.
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Osher Center for Integrative Health at Vanderbilt
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Gurjeet Birdee
role: PRINCIPAL_INVESTIGATOR
References: