AddictionNCT07071883
Group Activities to Support Addiction Recovery
A study testing Holotropic breathwork and Multiple modality in people with Addiction and Substance Use Disorders (SUD), run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Addiction, Substance Use Disorders (SUD)
- What is being tested?
- Holotropic breathwork and Multiple modality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2025to 10 Apr 2026
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Lincoln, Nebraska, 68506
About this study
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.
Read the detailed description
This study evaluates the feasibility, safety, acceptability, and preliminary psychological and behavioral effects of Holotropic Breathwork (HB) as a supportive intervention for individuals in recovery from substance use disorders. HB is compared with a Multiple-Modality (MM) activity day in the residential setting. The study also assesses HB delivered to individuals in community-based recovery settings.
Study Overview
The project includes two primary participant groups:
Arm A - Residential Participants
Participants are recruited from two residential treatment programs (CenterPointe Omaha and The Bridge Lincoln). This arm uses cluster randomization: two sites will host the HB intervention, while an independent residential cohort at The Bridge will receive the MM intervention. Participants at each site receive the intervention assigned to their facility.
Arm B - Community Participants
Community members in addiction recovery are recruited via flyers, social media, and word-of-mouth. Arm B participants receive HB only and are included to evaluate feasibility, acceptability, and pre/post changes in functioning.
Across both arms, participants are evaluated at baseline, <24 hours post-intervention, and at 1-, 3-, and 6-month follow-up.
Rationale and Scientific Framework
Holotropic Breathwork is a structured, facilitator-led breathing practice designed to produce non-ordinary states of consciousness without the use of pharmacological agents. Prior research suggests HB may improve psychological, interpersonal, and existential functioning-domains strongly associated with addiction recovery.
Guided by conceptual models from psychedelic-assisted therapy research, this study hypothesizes that HB may elicit:
Mystical-type experiences
Challenging experiences
Emotional breakthroughs
These experiences may lead to psychological insight, which may contribute to improvements in mood, interpersonal relationships, existential wellbeing, and ultimately reductions in cravings or lapses.
Interventions Holotropic Breathwork (HB)
HB sessions may include up to 30 participants and follow a standardized protocol conducted by certified facilitators and trained apprentices (approximate facilitator-to-breather ratio 1:5).
HB events comprise the following elements:
Pre-Session Screening
Urine pregnancy test for participants who could become pregnant
Seated blood pressure measurement (must be <140/90)
Review of PHQ-9 to identify acute suicide risk
Assessment of medical and psychiatric exclusion criteria
Opening Circle
Participant introductions
Review of confidentiality, safety expectations, and session agreements
Educational Presentation (~60 minutes)
Content includes:
History and principles of HB
Hylotropic vs. holotropic states
Grof's cartography of the psyche (biographical, perinatal, and transpersonal domains)
COEX systems and emotional memory patterns
Strategies for navigating challenging experiences
Roles of breathers and sitters
Individual Readiness Check-ins Each participant meets briefly with a facilitator to assess emotional readiness and address questions.
Breathwork Session (~2 hours 20 minutes)
Participants lie on mats, typically using eyeshades
Guided relaxation prompts followed by intensified, self-paced breathing
Purposefully sequenced music supports the internal process
Sitters provide assistance only upon explicit request
Facilitators monitor safety continuously and may support participants through physical expressions of emotional release, ensuring all touch is participant-directed and consent-based
Post-Session Processing
Brief one-on-one check-ins with a facilitator
Participants may draw, write, or rest
Integration Presentation (~60 minutes)
Overview of formal and informal integration practices
Guidance on self-care, managing stimulation, and delaying major decisions
Discussion of appropriate sharing of HB experiences
Closing Circle Participants share reflections voluntarily; additional one-on-one support is available.
HB sessions conducted in Arm B follow the same structure and staffing.
Multiple-Modality (MM) Activity Day (Arm A Comparator)
The MM day is an attention-matched comparator condition designed to provide supportive, group-based activities without inducing non-ordinary states of consciousness. It is delivered only at The Bridge Lincoln.
The MM session includes:
Opening Circle Participants introduce themselves and may share recovery reflections.
Sound Bath Introduction Video (7 minutes) A brief educational video describing sound-based relaxation practices.
Sound Bath Session (20 minutes) Participants experience a guided sound bath in a quiet, low-stimulation environment.
Progressive Relaxation Exercise (11 minutes) A recorded body-relaxation sequence guides participants through calming techniques.
Film Screening (1 hour 43 minutes) Participants view Ben Is Back, a film depicting addiction and family dynamics.
Facilitated Group Discussion A trained UNMC nursing faculty member leads a structured conversation on themes from the film.
Closing Circle Participants may share insights or reflections before the session ends.
Unlike HB, MM activities pose no known physiological risks; therefore individuals excluded from HB remain eligible for the MM day.
Eligibility Criteria Inclusion Criteria
Adults aged 19 and older
Met criteria for a substance use disorder within the past 5 years
Arm A participants must be enrolled in residential treatment
Exclusion Criteria for HB (Arm A HB and Arm B)
Participants are excluded from HB if any of the following apply:
Lifetime diagnosis of bipolar disorder
Psychotic disorder or lifetime history of psychotic symptoms
Cardiac condition, history of cardiac treatment, or current cardiac symptoms
Seizure disorder
Uncontrolled hypertension (≥140/90)
Glaucoma or retinal detachment
Recent significant surgeries
Pregnancy
Acute suicidal ideation with plan or intent
These exclusions do not apply to MM participants.
Recruitment and Informed Consent Arm A (Residential)
The PI works with clinical staff to identify eligible residents. The PI delivers a standardized presentation, answers questions, and obtains individual informed consent in a private setting.
Arm B (Community)
Recruitment materials are posted through treatment centers, recovery organizations, and social media. Interested individuals contact the PI, receive study information, and complete consent via Zoom or in private at a participating site.
Data Collection and Outcome Measures
Assessments occur at:
Baseline
<24 hours post-session
1 month
3 months
6 months
Measures include:
Substance use: Timeline Followback, craving scale
Mental health: PHQ-9, GAD-7
Interpersonal functioning: SIFS
Existential functioning: PIL-SF
Psychological insight: PILS-6
Experiential measures: Mystical Experience Questionnaire, Challenging Experience Questionnaire, Emotional Breakthrough Inventory
Acceptability surveys
All follow-up surveys are administered through REDCap.
Safety Monitoring
Participant safety is supported by:
Continuous facilitator monitoring during HB sessions
Immediate exclusion of participants with elevated BP or positive pregnancy test
Real-time review of PHQ-9 scores by the PI
Same-day and next-day follow-ups for participants experiencing significant emotional reactions
Transportation assistance for participants who are physically unsteady
Emergency protocols including activation of emergency medical services when indicated
Stopping Rule
The study will be halted if more than 15% of participants require outside medical or psychiatric treatment related to the intervention.
Integration Support
HB participants are invited to attend two optional Zoom-based integration groups held:
5-7 days post-session
12-14 days post-session
Sessions are led by certified facilitators and apprentices. These groups offer guidance and reflection but do not involve data collection.
Statistical Analysis
Paired-samples t-tests will evaluate pre-post changes within HB participants.
Chi-square tests will compare cravings and lapses between HB and MM groups in Arm A.
Feasibility and acceptability metrics will include recruitment yield, attrition, survey completeness, and qualitative acceptability responses.
The study is not powered for definitive clinical outcomes but will provide effect-size estimates and procedural feasibility data to inform larger trials.
Potential Benefits and Risks
Participants may experience reductions in stress or anxiety, emotional release, heightened psychological insight, and enhanced purpose or meaning in life. Risks include temporary dizziness, emotional discomfort, recollection of traumatic events, and other transient psychological reactions. HB has a long history of safe use when conducted by certified facilitators.
- Conditions
- Addiction, Substance Use Disorders (SUD)
- Being tested
- Holotropic breathwork, Multiple modality
- Keywords
- holotropic breathwork, addiction, recovery
- Medical subject headings
- Behavior, Addictive, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holotropic breathworkBehavioural
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.
Multiple modalityBehavioural
Multiple Modality (MM) intervention (yoga, meditation, and a film/discussion)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Holotropic breathwork; Behavioral: 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 Receives: Behavioral: Holotropic breathwork |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants reporting a change in their substance use
Timeline Followback (TLFB)
Measured: 1 month, 3 months, and 6 months
Secondary outcomes (10)
Change in Psychological Insight
Psychological Insight Scale (PILS-6)
Measured: Baseline, <24 hours post-session, 1 month, 3 months, and 6 months
Change in Depression Symptoms
Patient Health Questionnaire-9 (PHQ-9)
Measured: Baseline, 1 month, 3 months, and 6 months
Change in Anxiety Symptoms
Generalized Anxiety Disorder-7 (GAD-7)
Measured: Baseline, 1 month, 3 months, and 6 months
Change in Interpersonal Functioning
Self and Interpersonal Functioning Scale (SIFS)
Measured: Baseline, 1 month, 3 months, and 6 months
Change in Purpose in Life
Purpose in Life Test - Short Form (PIL-SF)
Measured: Baseline, 1 month, 3 months, and 6 months
Change in Cravings
Brief Craving Scale
Measured: Baseline, 1 month, 3 months, and 6 months
Mystical Experiences
Mystical Experiences Questionnaire (MEQ)
Measured: <24 hours post-session
Challenging Experiences
Challenging Experiences Questionnaire (CEQ)
Measured: <24 hours post-session
Emotional Breakthrough
Emotional Breakthrough Inventory (EBI)
Measured: <24 hours post-session
Acceptability of the Intervention
Custom Acceptability Survey
Measured: <24 hours post-session and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start27 Aug 2025
- Primary completion10 Apr 2026
- Study completion10 Apr 2026
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.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Guenzel, University of Nebraska
- Investigators
- Nicholas Arien Guenzel, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071883
- Sponsor's protocol ID
- 0449-24-FB
- Status last verified
- Jan 2026
- First submitted
- 8 Jul 2025
- Last updated
- 14 Apr 2026
- 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 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Activities to Support Addiction Recovery
- ClinicalTrials.gov ID
- NCT07071883
- Acronym / sponsor ID
- 0449-24-FB
- Conditions
- Addiction, Substance Use Disorders (SUD)
- Keywords
- holotropic breathwork, addiction, recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 27 Aug 2025 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 17 Jul 2025 (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 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.
Detailed description
This study evaluates the feasibility, safety, acceptability, and preliminary psychological and behavioral effects of Holotropic Breathwork (HB) as a supportive intervention for individuals in recovery from substance use disorders. HB is compared with a Multiple-Modality (MM) activity day in the residential setting. The study also assesses HB delivered to individuals in community-based recovery settings.
Study Overview
The project includes two primary participant groups:
Arm A - Residential Participants
Participants are recruited from two residential treatment programs (CenterPointe Omaha and The Bridge Lincoln). This arm uses cluster randomization: two sites will host the HB intervention, while an independent residential cohort at The Bridge will receive the MM intervention. Participants at each site receive the intervention assigned to their facility.
Arm B - Community Participants
Community members in addiction recovery are recruited via flyers, social media, and word-of-mouth. Arm B participants receive HB only and are included to evaluate feasibility, acceptability, and pre/post changes in functioning.
Across both arms, participants are evaluated at baseline, <24 hours post-intervention, and at 1-, 3-, and 6-month follow-up.
Rationale and Scientific Framework
Holotropic Breathwork is a structured, facilitator-led breathing practice designed to produce non-ordinary states of consciousness without the use of pharmacological agents. Prior research suggests HB may improve psychological, interpersonal, and existential functioning-domains strongly associated with addiction recovery.
Guided by conceptual models from psychedelic-assisted therapy research, this study hypothesizes that HB may elicit:
Mystical-type experiences
Challenging experiences
Emotional breakthroughs
These experiences may lead to psychological insight, which may contribute to improvements in mood, interpersonal relationships, existential wellbeing, and ultimately reductions in cravings or lapses.
Interventions Holotropic Breathwork (HB)
HB sessions may include up to 30 participants and follow a standardized protocol conducted by certified facilitators and trained apprentices (approximate facilitator-to-breather ratio 1:5).
HB events comprise the following elements:
Pre-Session Screening
Urine pregnancy test for participants who could become pregnant
Seated blood pressure measurement (must be <140/90)
Review of PHQ-9 to identify acute suicide risk
Assessment of medical and psychiatric exclusion criteria
Opening Circle
Participant introductions
Review of confidentiality, safety expectations, and session agreements
Educational Presentation (~60 minutes)
Content includes:
History and principles of HB
Hylotropic vs. holotropic states
Grof's cartography of the psyche (biographical, perinatal, and transpersonal domains)
COEX systems and emotional memory patterns
Strategies for navigating challenging experiences
Roles of breathers and sitters
Individual Readiness Check-ins Each participant meets briefly with a facilitator to assess emotional readiness and address questions.
Breathwork Session (~2 hours 20 minutes)
Participants lie on mats, typically using eyeshades
Guided relaxation prompts followed by intensified, self-paced breathing
Purposefully sequenced music supports the internal process
Sitters provide assistance only upon explicit request
Facilitators monitor safety continuously and may support participants through physical expressions of emotional release, ensuring all touch is participant-directed and consent-based
Post-Session Processing
Brief one-on-one check-ins with a facilitator
Participants may draw, write, or rest
Integration Presentation (~60 minutes)
Overview of formal and informal integration practices
Guidance on self-care, managing stimulation, and delaying major decisions
Discussion of appropriate sharing of HB experiences
Closing Circle Participants share reflections voluntarily; additional one-on-one support is available.
HB sessions conducted in Arm B follow the same structure and staffing.
Multiple-Modality (MM) Activity Day (Arm A Comparator)
The MM day is an attention-matched comparator condition designed to provide supportive, group-based activities without inducing non-ordinary states of consciousness. It is delivered only at The Bridge Lincoln.
The MM session includes:
Opening Circle Participants introduce themselves and may share recovery reflections.
Sound Bath Introduction Video (7 minutes) A brief educational video describing sound-based relaxation practices.
Sound Bath Session (20 minutes) Participants experience a guided sound bath in a quiet, low-stimulation environment.
Progressive Relaxation Exercise (11 minutes) A recorded body-relaxation sequence guides participants through calming techniques.
Film Screening (1 hour 43 minutes) Participants view Ben Is Back, a film depicting addiction and family dynamics.
Facilitated Group Discussion A trained UNMC nursing faculty member leads a structured conversation on themes from the film.
Closing Circle Participants may share insights or reflections before the session ends.
Unlike HB, MM activities pose no known physiological risks; therefore individuals excluded from HB remain eligible for the MM day.
Eligibility Criteria Inclusion Criteria
Adults aged 19 and older
Met criteria for a substance use disorder within the past 5 years
Arm A participants must be enrolled in residential treatment
Exclusion Criteria for HB (Arm A HB and Arm B)
Participants are excluded from HB if any of the following apply:
Lifetime diagnosis of bipolar disorder
Psychotic disorder or lifetime history of psychotic symptoms
Cardiac condition, history of cardiac treatment, or current cardiac symptoms
Seizure disorder
Uncontrolled hypertension (≥140/90)
Glaucoma or retinal detachment
Recent significant surgeries
Pregnancy
Acute suicidal ideation with plan or intent
These exclusions do not apply to MM participants.
Recruitment and Informed Consent Arm A (Residential)
The PI works with clinical staff to identify eligible residents. The PI delivers a standardized presentation, answers questions, and obtains individual informed consent in a private setting.
Arm B (Community)
Recruitment materials are posted through treatment centers, recovery organizations, and social media. Interested individuals contact the PI, receive study information, and complete consent via Zoom or in private at a participating site.
Data Collection and Outcome Measures
Assessments occur at:
Baseline
<24 hours post-session
1 month
3 months
6 months
Measures include:
Substance use: Timeline Followback, craving scale
Mental health: PHQ-9, GAD-7
Interpersonal functioning: SIFS
Existential functioning: PIL-SF
Psychological insight: PILS-6
Experiential measures: Mystical Experience Questionnaire, Challenging Experience Questionnaire, Emotional Breakthrough Inventory
Acceptability surveys
All follow-up surveys are administered through REDCap.
Safety Monitoring
Participant safety is supported by:
Continuous facilitator monitoring during HB sessions
Immediate exclusion of participants with elevated BP or positive pregnancy test
Real-time review of PHQ-9 scores by the PI
Same-day and next-day follow-ups for participants experiencing significant emotional reactions
Transportation assistance for participants who are physically unsteady
Emergency protocols including activation of emergency medical services when indicated
Stopping Rule
The study will be halted if more than 15% of participants require outside medical or psychiatric treatment related to the intervention.
Integration Support
HB participants are invited to attend two optional Zoom-based integration groups held:
5-7 days post-session
12-14 days post-session
Sessions are led by certified facilitators and apprentices. These groups offer guidance and reflection but do not involve data collection.
Statistical Analysis
Paired-samples t-tests will evaluate pre-post changes within HB participants.
Chi-square tests will compare cravings and lapses between HB and MM groups in Arm A.
Feasibility and acceptability metrics will include recruitment yield, attrition, survey completeness, and qualitative acceptability responses.
The study is not powered for definitive clinical outcomes but will provide effect-size estimates and procedural feasibility data to inform larger trials.
Potential Benefits and Risks
Participants may experience reductions in stress or anxiety, emotional release, heightened psychological insight, and enhanced purpose or meaning in life. Risks include temporary dizziness, emotional discomfort, recollection of traumatic events, and other transient psychological reactions. HB has a long history of safe use when conducted by certified facilitators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A--for individuals in residential treatment programs | Experimental | Behavioral: Holotropic breathwork, Behavioral: Multiple modalityArm 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. |
| B--for individuals living in the community | Experimental | Behavioral: Holotropic breathworkArm 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- Arm A: HB group and Arm B
- Arm A: MM group None
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 |
|---|---|---|
| Holotropic breathworkHB 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. | Behavioural | A--for individuals in residential treatment programs, B--for individuals living in the community |
| Multiple modalityMultiple Modality (MM) intervention (yoga, meditation, and a film/discussion) | Behavioural | A--for individuals in residential treatment programs |
Primary outcome
Number of participants reporting a change in their substance use
Time frame: 1 month, 3 months, and 6 months
Timeline Followback (TLFB)
10 secondary outcomes
Change in Psychological Insight
Time frame: Baseline, <24 hours post-session, 1 month, 3 months, and 6 months
Change in Depression Symptoms
Time frame: Baseline, 1 month, 3 months, and 6 months
Change in Anxiety Symptoms
Time frame: Baseline, 1 month, 3 months, and 6 months
Change in Interpersonal Functioning
Time frame: Baseline, 1 month, 3 months, and 6 months
Change in Purpose in Life
Time frame: Baseline, 1 month, 3 months, and 6 months
Change in Cravings
Time frame: Baseline, 1 month, 3 months, and 6 months
Mystical Experiences
Time frame: <24 hours post-session
Challenging Experiences
Time frame: <24 hours post-session
Emotional Breakthrough
Time frame: <24 hours post-session
Acceptability of the Intervention
Time frame: <24 hours post-session and 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- 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.
Nicholas Arien Guenzel, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holotropic breathwork and Multiple modality in people with Addiction and Substance Use Disorders (SUD), run by University of Nebraska 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 2 inclusion and 11 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: finished, as of the sponsor's last update on 14 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants reporting a change in their substance use (time frame: 1 month, 3 months, and 6 months). 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 14 Apr 2026.