Tapping in Together: A Pilot Study on Group Acupuncture for Ketamine Experience Integration

December 3, 2023 updated by: Marjorie Navarro, Academy of Oriental Medicine Austin

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10013
        • Cardea Ketamine Space

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
This is the group of participants who will receive group acupuncture after a ketamine experience.
Procedure: Acupuncture
The traditional East Asian methods of treating disease by inserting needles along specific pathways or meridians.
Other Names:
  • Acupuncture Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Experienced Integration Scale (EIS)
Time Frame: One day after experience
The scale is intended to gain a sense of the status of a participant's integration process after a psychedelic experience. Participants are asked to rate their agreement to 12 statements using a five-point Likert scale with the anchors "strongly disagree," "disagree," "neither agree nor disagree," "agree," and "strongly agree." The items are worded in a positive direction, so that higher scores indicating greater integration.
One day after experience
Experienced Integration Scale (EIS)
Time Frame: Three months after experience
The scale is intended to gain a sense of the status of a participant's integration process after a psychedelic experience. Participants are asked to rate their agreement to 12 statements using a five-point Likert scale with the anchors "strongly disagree," "disagree," "neither agree nor disagree," "agree," and "strongly agree." The items are worded in a positive direction, so that higher scores indicating greater integration.
Three months after experience

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academy of Oriental Medicine Austin

Investigators

  • Study Chair: William Morris, PhD, DAOM, Academy of Oriental Medicine Austin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2023

Primary Completion (Actual)

December 1, 2023

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

September 29, 2023

First Submitted That Met QC Criteria

September 30, 2023

First Posted (Actual)

October 6, 2023

Study Record Updates

Last Update Posted (Estimated)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 3, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 23C.MN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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