Breathwork-assisted Treatment for Cannabis Use Disorder

Substance Abuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05219825
• Other study ID #: 8165
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2022
• Est. completion date: August 2024

Study information

• Verified date: February 2024
• Source: New York State Psychiatric Institute
• Contact: Danielle Mayall, B.A
• Phone: (888) 497-8427
• Email: danielle.mayall[@]nyspi.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Addiction
• Behavior, Addictive
• Cannabis Abuse
• Cannabis Dependence
• Cannabis Use
• Cannabis Use Disorder
• Marijuana Abuse
• Substance Abuse
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Elias Dakwar

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of the breathwork session	Acceptability of the breathwork intervention through self-reported questionnaires.	One week after the breathing session.
Primary	Safety of the breathing session	Occurrence of adverse effects through a self-reported questionnaire.	24 hours after the breathing session.
Secondary	Change in Cue Reactivity	Serial visual analogue scale for craving elicited by cannabis use.	From baseline to 1 month after the breathing session.
Secondary	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.
Secondary	Change in cannabis use	Changes in cannabis use as measured by the Timeline Followback.	From baseline to 1 month after the breathing session.
Secondary	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
Secondary	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
Secondary	Heart Rate Variability	Polar (H10) chest strap	Measured during breathing session
Secondary	Electroencephalographic changes	Electroencephalograpy cap	Measured during breathing session