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Active, Not Recruiting

NCT Number: NCT05219825

Breathwork-assisted Treatment for Cannabis Use Disorder

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York State Psychiatric Institute

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Breathwork workshop

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.

Other names: Enhanced breathing session + Brief psychotherapeutic intervention

Primary outcomes

  1. Acceptability of the breathwork session

    Time frame: One week after the breathing session.

    Acceptability of the breathwork intervention through self-reported questionnaires.

  2. Safety of the breathing session

    Time frame: 24 hours after the breathing session.

    Occurrence of adverse effects through a self-reported questionnaire.

Secondary outcomes

  1. Change in Cue Reactivity

    Time frame: From baseline to 1 month after the breathing session.

    Serial visual analogue scale for craving elicited by cannabis use.

  2. Change in Motivation to Quit

    Time frame: From baseline to 1 month after the breathing session.

    Measured with the "Stages of Change Readiness and Treatment Eagerness Scale."

  3. Change in cannabis use

    Time frame: From baseline to 1 month after the breathing session.

    Changes in cannabis use as measured by the Timeline Followback.

  4. Phenomenology of breathwork #1

    Time frame: 24 hours after the breathing session

    Subjective experiences during the breathing session will be assessed with the 30-item Mystical Experience Questionnaire.

  5. Phenomenology of breathwork #2

    Time frame: Obtained 24 hours after the breathing session

    Subjective experiences during the breathing session will be assessed with the Emotional Breakthrough Inventory.

  6. Heart Rate Variability

    Time frame: Measured during breathing session

    Polar (H10) chest strap

  7. Electroencephalographic changes

    Time frame: Measured during breathing session

    Electroencephalograpy cap

Sponsors and collaborators

Lead sponsor

Elias Dakwar

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 2, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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