Breathwork-assisted Treatment for Substance Use Disorders

Sponsor

Elias Dakwar (Other)

Overall Status

Recruiting

CT.gov ID

NCT05219825

Collaborator

(none)

Enrollment

Location

Arm

17.8

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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 substance use disorders.

Condition or Disease	Intervention/Treatment	Phase
Addiction Substance Use Substance Abuse Substance Use Disorders Substance Dependence	Behavioral: Breathwork workshop	N/A

Detailed Description

This study will test a 1-week breathwork workshop for treatment-seeking adults with a diagnosis of a substance 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 substance use disorders. 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Breathwork-assisted Treatment for Substance Use Disorders: A Proof-of-concept Study

Actual Study Start Date :

Feb 6, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Breathwork group Treatment-seeking individuals with substance use disorders who will participate in the 1-week breathwork workshop.	Behavioral: Breathwork workshop 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

Arm

Intervention/Treatment

Experimental: Breathwork group

Treatment-seeking individuals with substance use disorders who will participate in the 1-week breathwork workshop.

Behavioral: Breathwork workshop

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

Outcome Measures

Primary Outcome Measures

Acceptability of the breathwork session [One week after the breathing session.]
Acceptability of the breathwork intervention through self-reported questionnaires.
Safety of the breathing session [24 hours after the breathing session.]
Occurrence of adverse effects through a self-reported questionnaire.

Secondary Outcome Measures

Change in Cue Reactivity [From baseline to 1 month after the breathing session.]
Serial visual analogue scale for craving elicited by substance use.
Change in Motivation to Quit [From baseline to 1 month after the breathing session.]
Measured with the "Stages of Change Readiness and Treatment Eagerness Scale."
Change in substance use [From baseline to 1 month after the breathing session.]
Changes in substance use as measured by the Timeline Followback.
Phenomenology of breathwork #1 [24 hours after the breathing session]
Subjective experiences during the breathing session will be assessed with the 30-item Mystical Experience Questionnaire.
Phenomenology of breathwork #2 [Obtained 24 hours after the breathing session]
Subjective experiences during the breathing session will be assessed with the Emotional Breakthrough Inventory.
Heart Rate Variability [Measured during breathing session]
Polar (H10) chest strap

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York State Psychiatric Institute	New York	New York	United States	10032

Sponsors and Collaborators

Elias Dakwar

Investigators

Principal Investigator: Silvia J Franco Corso, M.D, New York State Psychiatric Institute/ Columbia University Medical Center
Study Chair: Elias Dakwar, M.D, New York State Psychiatric Institute/ Columbia University Medical Center
Study Director: Kate O'Malley, M.A, New York State Psychiatric Institute/ Columbia University