NCT05219825

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

February 6, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

3.4 years

First QC Date

December 30, 2021

Last Update Submit

September 11, 2024

Conditions

AddictionSubstance AbuseCannabis Use DisorderCannabis UseCannabis DependenceCannabis Abuse

Keywords

Addictioncannabis use disorderBreathworkNon-ordinary states of consciousnessNon-ordinary experiencesContemplative practicesAltered states of consciousnessCannabis

Outcome Measures

Primary Outcomes (2)

  • Acceptability of the breathwork session

    Acceptability of the breathwork intervention through self-reported questionnaires.

    One week after the breathing session.

  • Safety of the breathing session

    Occurrence of adverse effects through a self-reported questionnaire.

    24 hours after the breathing session.

Secondary Outcomes (7)

  • 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

  • Phenomenology of breathwork #2

    Obtained 24 hours after the breathing session

  • +2 more secondary outcomes

Study Arms (1)

Breathwork group

EXPERIMENTAL

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

Behavioral: Breathwork workshop

Interventions

Breathwork workshopBEHAVIORAL

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.

Also known as: Enhanced breathing session + Brief psychotherapeutic intervention
Breathwork group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Behavior, AddictiveSubstance-Related DisordersMarijuana Abuse

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehaviorChemically-Induced DisordersMental Disorders

Study Officials

  • Silvia J Franco Corso, M.D

    New York State Psychiatric Institute/ Columbia University Medical Center

    PRINCIPAL INVESTIGATOR

  • Elias Dakwar, M.D

    New York State Psychiatric Institute/ Columbia University Medical Center

    STUDY CHAIR

  • Kate O'Malley, M.A

    New York State Psychiatric Institute/ Columbia University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Clinical Psychiatry

Study Record Dates

First Submitted

December 30, 2021

First Posted

February 2, 2022

Study Start

February 6, 2022

Primary Completion

June 30, 2025

Study Completion

December 31, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)