NCT07071883

Brief Summary

The purpose of this study is to pilot the use of Holotropic Breathwork (HB) for individuals seeking to recover from addiction. The study will have two arms: A--for individuals in residential treatment programs, B--for individuals living in the community. Arm A will use a cluster randomized intervention, providing HB for individuals at two facilities and a Multiple Modality (MM) intervention (soundbath, meditation, and a film/discussion) at a third facility. In Arm B, we seek to measure the feasibility, acceptability, and preliminary impact of HB among people with addiction living in the community. Arm B will be comprised of a single group and participants in this group will receive the same HB experience as the participants in the Arm A HB group. HB is the practice of self-directed hyperventilation while lying down with the support of a selected music set and trained facilitators. Participants may experience an expanded state of consciousness with altered cognition, perception, and emotions. HB has been associated improved mental functioning among the general public and people in addiction treatment, but has never been evaluated in a controlled trial. Inclusion criteria consist of being 19 years of age or older and having met criteria for a substance use disorder within the past five years. Additional inclusion criteria for participants in arm A include being in a residential addiction treatment program at CenterPointe or the Bridge. Exclusion criteria form the Arm A HB group and the Arm B group include having been diagnosed with a bipolar disorder or a psychotic disorder or having had psychotic symptoms at any point in life, diagnosed with a cardiac condition, received care for a cardiac condition, or have current cardiac symptoms, ever diagnosed with a seizure disorder, current uncontrolled hypertension (140/90 or greater), diagnosed with glaucoma or retinal detachment, recent surgeries, or currently pregnant. Four breathwork sessions will be held: two at the UNMC College of Nursing in Lincoln, one at CenterPointe in Omaha, and one at The Bridge in Lincoln. One MM session will be held at The Bridge in Lincoln.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

August 27, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2026

Completed
Last Updated

April 14, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

July 8, 2025

Last Update Submit

April 13, 2026

Conditions

AddictionSubstance Use Disorders (SUD)

Keywords

holotropic breathworkaddictionrecovery

Outcome Measures

Primary Outcomes (1)

  • Number of participants reporting a change in their substance use

    Timeline Followback (TLFB)

    1 month, 3 months, and 6 months

Secondary Outcomes (10)

  • Change in Psychological Insight

    Baseline, <24 hours post-session, 1 month, 3 months, and 6 months

  • Change in Depression Symptoms

    Baseline, 1 month, 3 months, and 6 months

  • Change in Anxiety Symptoms

    Baseline, 1 month, 3 months, and 6 months

  • Change in Interpersonal Functioning

    Baseline, 1 month, 3 months, and 6 months

  • Change in Purpose in Life

    Baseline, 1 month, 3 months, and 6 months

  • +5 more secondary outcomes

Study Arms (2)

A--for individuals in residential treatment programs

EXPERIMENTAL

Arm A will use a cluster randomized intervention, providing HB for individuals at two facilities and a Multiple Modality (MM) intervention (yoga, meditation, and a film/discussion) at a third facility.

Behavioral: Holotropic breathworkBehavioral: Multiple modality

B--for individuals living in the community

EXPERIMENTAL

Arm B will be comprised of a single group and participants in this group will receive the same HB experience as the participants in the Arm A HB group

Behavioral: Holotropic breathwork

Interventions

Holotropic breathworkBEHAVIORAL

HB is the practice of self-directed hyperventilation while lying down with the support of a selected music set and trained facilitators. Participants may experience an expanded state of consciousness with altered cognition, perception, and emotions.

A--for individuals in residential treatment programsB--for individuals living in the community
Multiple modalityBEHAVIORAL

Multiple Modality (MM) intervention (yoga, meditation, and a film/discussion)

A--for individuals in residential treatment programs

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Arm A 19 years of age or older Currently enrolled in a residential addiction treatment program at CenterPointe or the Bridge Met criteria for a substance use disorder in the past five years
  • Arm B 19 years of age or older Met criteria for a substance use disorder in the past five years

You may not qualify if:

  • Arm A: HB group and Arm B
  • Diagnosed with a bipolar disorder at any point in life (per self-report)
  • Diagnosed with a psychotic disorder or have had psychotic symptoms at any point in life (per self-report)
  • Diagnosed with a cardiac condition, received care for a cardiac condition, or have current cardiac symptoms (per self-report)
  • Ever diagnosed with a seizure disorder (per self-report)
  • Current uncontrolled hypertension (140/90 or greater) (measured the morning of the breathwork)
  • Ever diagnosed with glaucoma or retinal detachment
  • Recent surgeries
  • Currently pregnant (individuals who have engaged in sexual activity since their last menstrual period will be asked to submit a urine sample for a pregnancy screen the morning of the breathwork)
  • Acutely suicidal (i.e. with an intention and a plan)
  • Arm A: MM group None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center

Lincoln, Nebraska, 68506, United States

Location

MeSH Terms

Conditions

Behavior, AddictiveSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehaviorChemically-Induced DisordersMental Disorders

Study Officials

  • Nicholas Arien Guenzel, PhD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 8, 2025

First Posted

July 17, 2025

Study Start

August 27, 2025

Primary Completion

April 10, 2026

Study Completion

April 10, 2026

Last Updated

April 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)