Back to resultsBreathwork-assisted Treatment for Cannabis Use Disorder
Primary Purpose
Addiction, Substance Abuse, Cannabis Use Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breathwork workshop
Sponsored by
About this trial
This is an interventional treatment trial for Addiction focused on measuring Addiction, cannabis use disorder, Breathwork, Non-ordinary states of consciousness, Non-ordinary experiences, Contemplative practices, Altered states of consciousness, Cannabis
Eligibility Criteria
Inclusion Criteria:
- 18-70 years of age
- Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for active substance use disorder for any of the drug classes, except caffeine, including: alcohol; cannabis; hallucinogens; inhalants; opioids; sedatives, hypnotics, anxiolytics; stimulants (including cocaine); tobacco; and other or unknown substances.
- Seeking treatment for their addiction
Exclusion Criteria:
- Meets DSM-V criteria for schizophrenia or any psychotic illness or any dissociative disorder (Dissociative identity disorder, Dissociative amnesia, Depersonalization/derealization disorder).
- 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).
Sites / Locations
- New York State Psychiatric InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Breathwork group
Arm Description
Treatment-seeking individuals with cannabis use disorder who will participate in the 1-week breathwork workshop.
Outcomes
Primary Outcome Measures
Acceptability of the breathwork session
Acceptability of the breathwork intervention through self-reported questionnaires.
Safety of the breathing session
Occurrence of adverse effects through a self-reported questionnaire.
Secondary Outcome Measures
Change in Cue Reactivity
Serial visual analogue scale for craving elicited by cannabis use.
Change in Motivation to Quit
Measured with the "Stages of Change Readiness and Treatment Eagerness Scale."
Change in cannabis use
Changes in cannabis use as measured by the Timeline Followback.
Phenomenology of breathwork #1
Subjective experiences during the breathing session will be assessed with the 30-item Mystical Experience Questionnaire.
Phenomenology of breathwork #2
Subjective experiences during the breathing session will be assessed with the Emotional Breakthrough Inventory.
Heart Rate Variability
Polar (H10) chest strap
Electroencephalographic changes
Electroencephalograpy cap
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05219825
Brief Title
Breathwork-assisted Treatment for Cannabis Use Disorder
Official Title
Breathwork-assisted Treatment for Cannabis Use Disorder: A Proof-of-concept Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Elias Dakwar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addiction, Substance Abuse, Cannabis Use Disorder, Cannabis Use, Cannabis Dependence, Cannabis Abuse
Keywords
Addiction, cannabis use disorder, Breathwork, Non-ordinary states of consciousness, Non-ordinary experiences, Contemplative practices, Altered states of consciousness, Cannabis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Breathwork group
Arm Type
Experimental
Arm Description
Treatment-seeking individuals with cannabis use disorder who will participate in the 1-week breathwork workshop.
Intervention Type
Behavioral
Intervention Name(s)
Breathwork workshop
Other Intervention Name(s)
Enhanced breathing session + Brief psychotherapeutic intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability of the breathwork session
Description
Acceptability of the breathwork intervention through self-reported questionnaires.
Time Frame
One week after the breathing session.
Title
Safety of the breathing session
Description
Occurrence of adverse effects through a self-reported questionnaire.
Time Frame
24 hours after the breathing session.
Secondary Outcome Measure Information:
Title
Change in Cue Reactivity
Description
Serial visual analogue scale for craving elicited by cannabis use.
Time Frame
From baseline to 1 month after the breathing session.
Title
Change in Motivation to Quit
Description
Measured with the "Stages of Change Readiness and Treatment Eagerness Scale."
Time Frame
From baseline to 1 month after the breathing session.
Title
Change in cannabis use
Description
Changes in cannabis use as measured by the Timeline Followback.
Time Frame
From baseline to 1 month after the breathing session.
Title
Phenomenology of breathwork #1
Description
Subjective experiences during the breathing session will be assessed with the 30-item Mystical Experience Questionnaire.
Time Frame
24 hours after the breathing session
Title
Phenomenology of breathwork #2
Description
Subjective experiences during the breathing session will be assessed with the Emotional Breakthrough Inventory.
Time Frame
Obtained 24 hours after the breathing session
Title
Heart Rate Variability
Description
Polar (H10) chest strap
Time Frame
Measured during breathing session
Title
Electroencephalographic changes
Description
Electroencephalograpy cap
Time Frame
Measured during breathing session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Mayall, B.A
Phone
(888) 497-8427
Email
danielle.mayall@nyspi.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Silvia J Franco Corso, M.D
Phone
(914) 481-3820
Email
silvia.franco-corso@nyspi.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia J Franco Corso, M.D
Organizational Affiliation
New York State Psychiatric Institute/ Columbia University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elias Dakwar, M.D
Organizational Affiliation
New York State Psychiatric Institute/ Columbia University Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kate O'Malley, M.A
Organizational Affiliation
New York State Psychiatric Institute/ Columbia University
Official's Role
Study Director
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Franco Corso, M.D.
Email
silvia.franco-corso@nyspi.columbia.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Breathwork-assisted Treatment for Cannabis Use Disorder
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