Breathwork-assisted Treatment for Cannabis Use Disorder

NCT ID: NCT05219825

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-06

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this proof-of-concept study is to evaluate the safety, feasibility and acceptability of a breathwork workshop intervention in individuals with cannabis use disorder.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study will test a 1-week breathwork workshop for treatment-seeking adults with a diagnosis of cannabis use disorder. The intervention consists of an enhanced breathing session with evocative music to facilitate experiencing non-ordinary states of consciousness, in addition to brief therapeutic interventions based on Motivational Interviewing and Mindfulness-based Relapse Prevention (MBRP). The primary aim is to test the acceptability, feasibility and safety of enhanced breathwork in a therapeutic framework for cannabis use disorder. In addition, the investigators seek to understand the phenomenology of breathwork that may explain any change related to addictive behaviors, as well as biological changes that occur during the breathwork session through heart rate variability and electroencephalography.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Addiction Substance Abuse Cannabis Use Disorder Cannabis Use Cannabis Dependence Cannabis Abuse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Breathwork group

Treatment-seeking individuals with cannabis use disorder who will participate in the 1-week breathwork workshop.

Group Type EXPERIMENTAL

Breathwork workshop

Intervention Type BEHAVIORAL

Participants will complete 1.5 hours of breathwork session in addition to a total of 6 hours of brief psychotherapeutic intervention in a span of 1 week. The therapy sessions will occur both before and after the breathing session.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Breathwork workshop

Participants will complete 1.5 hours of breathwork session in addition to a total of 6 hours of brief psychotherapeutic intervention in a span of 1 week. The therapy sessions will occur both before and after the breathing session.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Enhanced breathing session + Brief psychotherapeutic intervention

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18-70 years of age
* Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for active cannabis use disorder.
* Seeking treatment for their cannabis use

Exclusion Criteria

* Meets DSM-V criteria for schizophrenia or any psychotic illness or any dissociative disorder (Dissociative identity disorder, Dissociative amnesia, Depersonalization/derealization disorder).
* Active substance use disorder except for cannabis, nicotine, and caffeine.
* History of severe withdrawal symptoms (i.e withdrawal seizures).
* History of dementia, epilepsy or seizures, cardiac arrhythmia, pacemaker/defibrillator, heart failure, asthma, panic disorder and other respiratory illnesses (ie: COPD).
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Elias Dakwar

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Elias Dakwar

Associate Professor of Clinical Psychiatry

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Silvia J Franco Corso, M.D

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute/ Columbia University Medical Center

Elias Dakwar, M.D

Role: STUDY_CHAIR

New York State Psychiatric Institute/ Columbia University Medical Center

Kate O'Malley, M.A

Role: STUDY_DIRECTOR

New York State Psychiatric Institute/ Columbia University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

New York State Psychiatric Institute

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

8165

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Brief Intervention for Cannabis Use
NCT06395389 RECRUITING NA
Marijuana Treatment Project - 3
NCT00107588 COMPLETED NA
Biofeedback for Adolescent Cannabis Use Disorder
NCT02059083 WITHDRAWN PHASE1/PHASE2
The Teen Marijuana Check-Up
NCT00350285 COMPLETED PHASE2