NCT06070090

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 6, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

October 9, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

2 months

First QC Date

September 29, 2023

Last Update Submit

June 24, 2025

Conditions

Keywords

Ketamine

Outcome Measures

Primary Outcomes (2)

  • Experienced Integration Scale (EIS)

    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)

    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

Study Arms (1)

Treatment Group

EXPERIMENTAL

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

Procedure: Acupuncture

Interventions

AcupuncturePROCEDURE

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

Also known as: Acupuncture Therapy
Treatment Group

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardea Ketamine Space

New York, New York, 10013, United States

Location

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • William Morris, PhD, DAOM

    Academy of Oriental Medicine Austin

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Licensed Acupuncturist

Study Record Dates

First Submitted

September 29, 2023

First Posted

October 6, 2023

Study Start

October 9, 2023

Primary Completion

December 1, 2023

Study Completion

March 1, 2024

Last Updated

June 27, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations