AddictionNCT05219825
Breathwork-assisted Treatment for Cannabis Use Disorder
A study testing Breathwork workshop in people with Addiction and Substance Abuse, run by Elias Dakwar at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Addiction, Substance Abuse, Cannabis Use Disorder
- What is being tested?
- Breathwork workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Breathwork-assisted Treatment for Cannabis Use Disorder: a Proof-of-concept Study
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.
Read the 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.
- Conditions
- Addiction, Substance Abuse, Cannabis Use Disorder, Cannabis Use, Cannabis Dependence, Cannabis Abuse
- Being tested
- Breathwork workshop
- Keywords
- Addiction, cannabis use disorder, Breathwork, Non-ordinary states of consciousness, Non-ordinary experiences, Contemplative practices, Altered states of consciousness, Cannabis
- Medical subject headings
- Behavior, Addictive, Substance-Related Disorders, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathwork workshopBehavioural
Also called Enhanced breathing session + Brief psychotherapeutic intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| Breathwork group | Experimental | Treatment-seeking individuals with cannabis use disorder who will participate in the 1-week breathwork workshop. Receives: Behavioral: Breathwork workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the breathwork session
Acceptability of the breathwork intervention through self-reported questionnaires.
Measured: One week after the breathing session.
Safety of the breathing session
Occurrence of adverse effects through a self-reported questionnaire.
Measured: 24 hours after the breathing session.
Secondary outcomes (7)
Change in Cue Reactivity
Serial visual analogue scale for craving elicited by cannabis use.
Measured: From baseline to 1 month after the breathing session.
Change in Motivation to Quit
Measured with the "Stages of Change Readiness and Treatment Eagerness Scale."
Measured: From baseline to 1 month after the breathing session.
Change in cannabis use
Changes in cannabis use as measured by the Timeline Followback.
Measured: From baseline to 1 month after the breathing session.
Phenomenology of breathwork #1
Subjective experiences during the breathing session will be assessed with the 30-item Mystical Experience Questionnaire.
Measured: 24 hours after the breathing session
Phenomenology of breathwork #2
Subjective experiences during the breathing session will be assessed with the Emotional Breakthrough Inventory.
Measured: Obtained 24 hours after the breathing session
Heart Rate Variability
Polar (H10) chest strap
Measured: Measured during breathing session
Electroencephalographic changes
Electroencephalograpy cap
Measured: Measured during breathing session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start6 Feb 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elias Dakwar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elias Dakwar, New York State Psychiatric Institute
- Investigators
- Silvia J Franco Corso, M.D, Principal investigator, New York State Psychiatric Institute/ Columbia University Medical CenterElias Dakwar, M.D, Study chair, New York State Psychiatric Institute/ Columbia University Medical CenterKate O'Malley, M.A, Study director, New York State Psychiatric Institute/ Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219825
- Sponsor's protocol ID
- 8165
- Status last verified
- Sep 2024
- First submitted
- 30 Dec 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathwork-assisted Treatment for Cannabis Use Disorder: a Proof-of-concept Study
- ClinicalTrials.gov ID
- NCT05219825
- Acronym / sponsor ID
- 8165
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Elias DakwarUniversity, hospital or other
- Study start
- 6 Feb 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breathwork group | Experimental | Behavioral: Breathwork workshopTreatment-seeking individuals with cannabis use disorder who will participate in the 1-week breathwork workshop. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathwork workshopAlso: Enhanced breathing session + Brief psychotherapeutic interventionParticipants 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. | Behavioural | Breathwork group |
Primary outcome
Acceptability of the breathwork session
Time frame: One week after the breathing session.
Acceptability of the breathwork intervention through self-reported questionnaires.
Safety of the breathing session
Time frame: 24 hours after the breathing session.
Occurrence of adverse effects through a self-reported questionnaire.
7 secondary outcomes
Change in Cue Reactivity
Time frame: From baseline to 1 month after the breathing session.
Change in Motivation to Quit
Time frame: From baseline to 1 month after the breathing session.
Change in cannabis use
Time frame: From baseline to 1 month after the breathing session.
Phenomenology of breathwork #1
Time frame: 24 hours after the breathing session
Phenomenology of breathwork #2
Time frame: Obtained 24 hours after the breathing session
Heart Rate Variability
Time frame: Measured during breathing session
Electroencephalographic changes
Time frame: Measured during breathing session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia J Franco Corso, M.D principal investigator
New York State Psychiatric Institute/ Columbia University Medical Center
Elias Dakwar, M.D study chair
New York State Psychiatric Institute/ Columbia University Medical Center
Kate O'Malley, M.A study director
New York State Psychiatric Institute/ Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathwork workshop in people with Addiction and Substance Abuse, run by Elias Dakwar at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the breathwork session (time frame: One week after the breathing session.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.