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

Sponsor

Academy of Oriental Medicine Austin (Other)

Overall Status

Recruiting

CT.gov ID

NCT06070090

Collaborator

(none)

Enrollment

Location

Arm

5.5

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acupuncture	Procedure: Acupuncture	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Sep 20, 2023

Anticipated Primary Completion Date :

Dec 2, 2023

Anticipated Study Completion Date :

Mar 4, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Experienced Integration Scale (EIS) [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.
Experienced Integration Scale (EIS) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardea Ketamine Space	New York	New York	United States	10013

Sponsors and Collaborators

Academy of Oriental Medicine Austin

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marjorie Navarro, Licensed Acupuncturist, Academy of Oriental Medicine Austin

ClinicalTrials.gov Identifier:

NCT06070090

Other Study ID Numbers:

23C.MN

First Posted:

Oct 6, 2023

Last Update Posted:

Oct 6, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Marjorie Navarro, Licensed Acupuncturist, Academy of Oriental Medicine Austin

Ketamine

Study Results

No Results Posted as of Oct 6, 2023