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

NCT ID: NCT06070090

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-09
• Study Completion Date: 2024-03-01

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.

Conditions

Acupuncture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Treatment Group

This is the group of participants who will receive group acupuncture after a ketamine experience.

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: PROCEDURE

The traditional East Asian methods of treating disease by inserting needles along specific pathways or meridians.

Interventions

Acupuncture

The traditional East Asian methods of treating disease by inserting needles along specific pathways or meridians.

Intervention Type: PROCEDURE

Other Intervention Names

Acupuncture Therapy

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Academy of Oriental Medicine Austin

OTHER

Sponsor Role: lead

Responsible Party

Marjorie Navarro

Licensed Acupuncturist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William Morris, PhD, DAOM

Role: STUDY_CHAIR

Academy of Oriental Medicine Austin

Locations

Cardea Ketamine Space

New York, New York, United States

Countries

United States

Other Identifiers

23C.MN

Identifier Type: -

Identifier Source: org_study_id