Clinical trial NCT06070090: Tapping in Together: A Pilot Study on Group Acupuncture for Ketamine Experience Integration
Official title: Tapping in Together: A Pilot Study on Group Acupuncture for Ketamine Experience Integration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acupuncture
Keywords: Ketamine
Lead sponsor: Academy of Oriental Medicine Austin
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: An intention-to-treat approach will be used to approximate real-world conditions wherein results will be included even if a participant decides not to participate in the group acupuncture session.
Primary purpose: OTHER

Brief summary: The goal of this pilot trial is to learn about using acupuncture for ketamine experience integration in adults aged 21-65 who are medically cleared for a ketamine prescription. The aim is to inform future controlled trials investigating efficacy by evaluating the success of:

* recruitment
* retention
* assessment procedures
* implementation of group acupuncture interventions performed just after a ketamine experience

Participants will be given acupuncture in a group setting after a small-group ketamine experience. The following day, participants will be asked to complete a few brief surveys about their experience.

Detailed description: The study will solicit participants to enroll in a physician-supervised ketamine experience directly followed by group acupuncture administered in New York City, between October 1, 2023 and February 28, 2024. A group of 12-28 participants will be enrolled in the study and assigned a participant ID once screened by the researcher and medically approved by the prescribing physician.

Group acupuncture treatments will be conducted one hour after a group ketamine experience commences. The group acupuncture sessions will start with the researcher approaching each participant individually and asking to examine their pulse and tongue. The participants will be given an opportunity to share any information they would like to about specific issues they would like to address with acupuncture. If nothing is shared, the researcher will select treatment points based on their pulse, tongue, body palpation, and intake data. The general location of the points selected will be shared with the participant to gain their consent for treating those areas prior to needle insertion. While the acupuncture needles are retained, participants will rest with music playing. The needles will then be removed, one at a time, from each patient in order of treatment (unless a participant requests needle removal before then). After needle removal, the participants will be asked to sit up for a few minutes before exiting the treatment room. Both the licensed acupuncturist researcher and a psychotherapist will be in the treatment room throughout the 1-hour group acupuncture session.

Participants will be emailed a validated survey via a REDCap secure link before the group acupuncture session (if they had a previous ketamine experience), after their group acupuncture session as well as 3 months from the date of their group acupuncture session. Participants will also be sent optional feedback forms through REDCap after each acupuncture session.

Eligibility criteria: Inclusion Criteria:

* between ages 21-65
* participant in a group ketamine experience between October 1, 2023 and February 28, 2024

Exclusion Criteria:

* currently pregnant or breastfeeding
* has a terminal illness
* does not pass medical clearance for ketamine prescription

Primary outcomes:
measure: Experienced Integration Scale (EIS)
timeFrame: One day after experience
measure: Experienced Integration Scale (EIS)
timeFrame: Three months after experience
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Cardea Ketamine Space
state: New York
Study officials:
affiliation: Academy of Oriental Medicine Austin
name: William Morris, PhD, DAOM
role: STUDY_CHAIR
References: