Breathwork-assisted Treatment for Cannabis Use Disorder

Breathwork-assisted Treatment for Cannabis Use Disorder: A Proof-of-concept Study

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.

Study Overview

• Status: Recruiting
• Conditions: Addiction; Cannabis Dependence; Cannabis Use; Substance Abuse; Cannabis Abuse; Cannabis Use Disorder
• Intervention / Treatment: Behavioral: Breathwork workshop

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danielle Mayall, B.A; Phone Number: (888) 497-8427; Email: danielle.mayall@nyspi.columbia.edu
• Study Contact Backup: Name: Silvia J Franco Corso, M.D; Phone Number: (914) 481-3820; Email: silvia.franco-corso@nyspi.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • New York State Psychiatric Institute
      • Contact: Silvia Franco Corso, M.D.; Email: silvia.franco-corso@nyspi.columbia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breathwork group; Treatment-seeking individuals with cannabis use disorder who will participate in the 1-week breathwork workshop.	Behavioral: 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.; Other Names: Enhanced breathing session + Brief psychotherapeutic intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the breathwork session	Acceptability of the breathwork intervention through self-reported questionnaires.	One week after the breathing session.
Safety of the breathing session	Occurrence of adverse effects through a self-reported questionnaire.	24 hours after the breathing session.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cue Reactivity	Serial visual analogue scale for craving elicited by cannabis use.	From baseline to 1 month after the breathing session.
Change in Motivation to Quit	Measured with the "Stages of Change Readiness and Treatment Eagerness Scale."	From baseline to 1 month after the breathing session.
Change in cannabis use	Changes in cannabis use as measured by the Timeline Followback.	From baseline to 1 month after the breathing session.
Phenomenology of breathwork #1	Subjective experiences during the breathing session will be assessed with the 30-item Mystical Experience Questionnaire.	24 hours after the breathing session
Phenomenology of breathwork #2	Subjective experiences during the breathing session will be assessed with the Emotional Breakthrough Inventory.	Obtained 24 hours after the breathing session
Heart Rate Variability	Polar (H10) chest strap	Measured during breathing session
Electroencephalographic changes	Electroencephalograpy cap	Measured during breathing session

Collaborators and Investigators

• Sponsor: Elias Dakwar
• Investigators: Principal Investigator: Silvia J Franco Corso, M.D, New York State Psychiatric Institute/ Columbia University Medical Center; Study Chair: Elias Dakwar, M.D, New York State Psychiatric Institute/ Columbia University Medical Center; Study Director: Kate O'Malley, M.A, New York State Psychiatric Institute/ Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: December 30, 2021
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Addiction; Cannabis; cannabis use disorder; Breathwork; Non-ordinary states of consciousness; Non-ordinary experiences; Contemplative practices; Altered states of consciousness
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Compulsive Behavior; Impulsive Behavior; Substance-Related Disorders; Marijuana Abuse; Behavior, Addictive; Psychotropic Drugs
• Other Study ID Numbers: 8165

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