Clinical trial NCT05219825: Breathwork-assisted Treatment for Cannabis Use Disorder
Official title: Breathwork-assisted Treatment for Cannabis Use Disorder: a Proof-of-concept Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Acceptability of the breathwork session
timeFrame: One week after the breathing session.
measure: Safety of the breathing session
timeFrame: 24 hours after the breathing session.
Secondary outcomes:
measure: Change in Cue Reactivity
timeFrame: From baseline to 1 month after the breathing session.
measure: Change in Motivation to Quit
timeFrame: From baseline to 1 month after the breathing session.
measure: Change in cannabis use
timeFrame: From baseline to 1 month after the breathing session.
measure: Phenomenology of breathwork #1
timeFrame: 24 hours after the breathing session
measure: Phenomenology of breathwork #2
timeFrame: Obtained 24 hours after the breathing session
measure: Heart Rate Variability
timeFrame: Measured during breathing session
measure: Electroencephalographic changes
timeFrame: Measured during breathing session
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute/ Columbia University Medical Center
name: Silvia J Franco Corso, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: New York State Psychiatric Institute/ Columbia University Medical Center
name: Elias Dakwar, M.D
role: STUDY_CHAIR
affiliation: New York State Psychiatric Institute/ Columbia University
name: Kate O'Malley, M.A
role: STUDY_DIRECTOR
References: