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Clinical Trials/NCT05219825
NCT05219825
Recruiting
Not Applicable

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

Elias Dakwar1 site in 1 country10 target enrollmentFebruary 6, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Addiction
Sponsor
Elias Dakwar
Enrollment
10
Locations
1
Primary Endpoint
Safety of the breathing session
Status
Recruiting
Last Updated
2 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
February 6, 2022
End Date
August 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Elias Dakwar
Responsible Party
Sponsor Investigator
Principal Investigator

Elias Dakwar

Associate Professor of Clinical Psychiatry

New York State Psychiatric Institute

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Safety of the breathing session

Time Frame: 24 hours after the breathing session.

Occurrence of adverse effects through a self-reported questionnaire.

Acceptability of the breathwork session

Time Frame: One week after the breathing session.

Acceptability of the breathwork intervention through self-reported questionnaires.

Secondary Outcomes

  • Phenomenology of breathwork #2(Obtained 24 hours after the breathing session)
  • Heart Rate Variability(Measured during breathing session)
  • Change in Cue Reactivity(From baseline to 1 month after the breathing session.)
  • Change in Motivation to Quit(From baseline to 1 month after the breathing session.)
  • Change in cannabis use(From baseline to 1 month after the breathing session.)
  • Phenomenology of breathwork #1(24 hours after the breathing session)
  • Electroencephalographic changes(Measured during breathing session)

Study Sites (1)

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