AddictionNCT07510256
Effects of Breathwork and Meditation on Addiction Recovery
A study testing SKY Breathing Program in people with Addiction and Addiction Disorders, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Emotional wellness can play a vital role in supporting recovery from substance use disorder (SUD). Developing skills to regulate emotions and manage stress during early stages of recovery can help manage triggers and prevent relapse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Addiction, Addiction Disorders
- What is being tested?
- SKY Breathing Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2024to 2 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recovery center patients at Horizon Health Services who are participating in the SKY Recovery program are eligible.
Who cannot join
- Recovery center patients who are not participating in the SKY Recovery program are not eligible for participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Horizon Health Inpatient and Residential Addiction Recovery
Sanborn, New York, 90024
About this study
Official title: Effects of SKY Breathwork and Meditation Program on Emotional Well-being and Craving in Individuals Recovering From Substance Use Disorder
Emotional wellness can play a vital role in supporting recovery from substance use disorder (SUD). Developing skills to regulate emotions and manage stress during early stages of recovery can help manage triggers and prevent relapse. Controlled breathing (i.e., intentional manipulation of rate and/or depth of breathing over time - often referred to as "breathwork") can enhance emotion regulation, but their effects have been minimally studied in individuals recovering from SUD.
This randomized controlled pilot study will examine the impact of breathwork and meditation training program ("SKY Recovery") designed for people in substance use recovery. It will take place at a residential substance use recovery treatment center in upstate New York with patients in recovery who have elected to participate in the SKY Recovery program delivered at the treatment center. The study will compare two groups (SKY Recovery vs. Control) to assess the intervention's impact on emotional well-being and craving. Participants randomized to the SKY group will complete a 5-day intensive workshop followed by weekly follow-up sessions. The Control group will receive the same intervention after a delay. Validated measures of emotion regulation, craving, and sleep quality will be collected at baseline, one week after the program, and again 3 weeks after the program to determine efficacy and feasibility for a larger trial.
Read the detailed description
Emotional wellness can play a vital role in supporting recovery from substance use disorder. Developing skills to regulate emotions and manage stress during early stages of recovery can help manage triggers and prevent relapse. Controlled breathing (i.e., intentional manipulation of rate and/or depth of breathing over time - or "breathwork") can enhance emotional wellbeing (e.g., improve emotion regulation), but very little research has explored the impact of breathwork as a healthy coping mechanism for managing emotions and triggers in the context of recovery from substance use disorder.
The goal of this study is to obtain initial data on efficacy of a biopsychosocial intervention that involves breathwork as an adjunct to standard care in a residential treatment setting. Biopsychosocial interventions (e.g., "SKY Recovery") that focus on breathwork techniques, such as Sudarshan Kriya Yoga (SKY), reduce stress, anxiety and depressive symptoms in healthy individuals as well as those with depression, anxiety, and Post-traumatic Stress Disorder. They also reduce craving and withdrawal symptoms in people with Tobacco Use Disorder. Breathwork interventions improve quality of life, particularly in the psychological dimension, for people with opioid use disorder, reducing craving, depression, and increasing social and physical functioning. Craving and withdrawal symptoms promote the maintenance of addiction and predict return to substance misuse, and they are linked to the stress response in people who have substance use disorders. Results of prior studies thereby offer the promise of breathwork as adjunctive therapy for substance use disorder (SUD). Yet, breathwork has only minimally been examined in people with SUDs.
The aims of this pilot study are to evaluate the effectiveness of the SKY Recovery program in individuals with SUDs on emotional wellbeing and craving. Emotion regulation, impulsivity, and distress tolerance will be measured as indicators of emotional wellbeing using self-report questionnaires. 100 adult participants (aiming for 50 male and 50 female, ≥18 years old) who are scheduled to participate in the SKY Recovery program in a residential community treatment center will be enrolled. They will be randomized to two groups: SKY and Control ("delayed start"). Participants in the SKY group will receive the SKY Recovery Program (5 days, 3 h/day) followed by guided weekly in-person group practice sessions (1 h) for 3 weeks. SKY is typically taught in groups; thus, patients will be trained in cohorts of 4-10 people. The delayed-start Control group will receive the SKY Recovery program after all measurements have been obtained from the SKY group. Measurements will be taken before and after the intensive 5-day SKY training, one week after, and again 3 weeks after . Emotional wellbeing (e.g., emotion regulation) will be measured using standardized self-report questionnaires. Craving for their primary substance of choice will be measured using a brief self-report questionnaire. As sleep is related to emotional wellness and is often disrupted in individuals with SUDs, we will also obtain self-report ratings of sleep quality. We will address the following specific aims:
Aim 1. Evaluate the effects of SKY Recovery program on emotional wellbeing in patients receiving treatment for substance use disorder in a residential community setting. Hypothesis 1: Emotion regulation difficulties, impulsivity, and distress intolerance will be reduced and sleep quality will increase relative to baseline - more in the SKY group than in the Control group.
Aim 2. Evaluate the effects of SKY Recovery program on craving in patients receiving treatment for substance use disorder in a residential community setting. Hypothesis 2: Craving will be reduced relative to baseline - more in the SKY group than in the Control group.
- Conditions
- Addiction, Addiction Disorders
- Being tested
- SKY Breathing Program
- Keywords
- breathwork, mind-body practices, controlled breathing, Sudarshan Kriya Yoga, addiction recovery, biopsychosocial interventions, substance use disorder, residential treatment, behavioral interventions, meditation
- 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.
SKY Breathing ProgramBehavioural
The main breathing technique taught in SKY Recovery program consists of multiple, staged components for progressively deeper relaxation and mental clarity. The first component involves a slow breathing technique (ujjayi or "ocean breath") that increases airway resistance during inspiration/expiration and controls airflow to prolong each breathing cycle to an exact count. The subjective experience is physical and mental calmness with alertness. In the second component ("bellows breath"), air is rapidly inhaled and forcefully exhaled at a rate of 30 breaths/minute, leading to excitation followed by calmness. The last component, Sudarshan Kriya ("proper vision by purifying action"), involves cyclical slow/medium/fast breathing. Together, these techniques can take 20 min and is followed by a 5 min rest period (total: 25 min). The program also includes training in mantra-based meditation (Sahaj Samadhi) - invoking a word ("mantra") to redirect the mind towards a meditative state.
| Study group | Role | What they receive |
|---|---|---|
| SKY Recovery Intervention | Experimental | The SKY Recovery program centers around a breathing meditation technique, called Sudarshan Kriya Yoga, which consists of multiple, staged components designed to progressively deepen relaxation and bring mental clarity. Participants also learn a mantra-based meditation technique that complements the breathwork. The program also includes education on emotion regulation practices (e.g., cognitive reframing). Receives: Behavioral: SKY Breathing Program |
| Delayed-start Control | No intervention | The delayed-start control group will receive the SKY Recovery program after all measurements have been obtained from the SKY group. Measurements will be taken before and after the intensive 5-day SKY Recovery program, one week later, and at the end (4 weeks after initiation) of the weekly guided practice period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotion regulation
Emotional well-being is a critical factor in stabilized recovery from substance use disorders. Emotion regulation will be measured as an indicator of emotional well-being (primary endpoint) using a standardized self-report questionnaire. The Difficulties in Emotion Regulation Scale is a widely used self-report questionnaire designed to assess problems with emotion regulation, especially how people understand, accept, and manage their emotional responses. We will use the brief version (18-items, Victor \& Klonsky, 2016). This will be obtained a few days before the SKY Recovery program, 1 week after, and 3 weeks after.
Measured: 6 weeks
Craving
Craving is one of the indicators of recovery from substance use disorder and is closely tied to emotional well-being. Craving for the participant's primary substance of choice will be assessed via self-report using a brief craving scale. The Craving Scale (McHugh et al., 2021) consists of three questions assessing desire to use the substance of choice (1) within the last 24 hours, (2) when imagining being in an environment where the substance was previously used, and (3) when something in the environment reminds them of using the substance. This will be obtained a few days before the SKY Recovery program, 1 week after, and 3 weeks after.
Measured: 6 weeks
Secondary outcomes (3)
Impulsivity
Impulsivity is an aspect of emotional well-being, often reflecting how well emotions are being regulated. We will use the UPPS Impulsive Behavior Scale (Whiteside \& Lynam, 2001), developed to measure four facets of impulsivity: urgency, lack of premeditation, lack of perseverance, and sensation-seeking. We will use the short version (20 items; Cyders et al., 2014). This will be obtained a few days before the SKY Recovery program, 1 week after, and 3 weeks after.
Measured: 6 weeks
Distress intolerance
Distress intolerance is a central aspect of emotional well-being that often precedes craving for substances. It will be measured using the Distress Intolerance Index (DII; McHugh \& Otto, 2012b), a 10-item self-report measure designed to assess the inability to tolerate negative states. This will be obtained a few days before the SKY Recovery program, 1 week after, and 3 weeks after.
Measured: 6 weeks
Sleep Quality
Sleep quality is another important aspect of emotional well-being which can be significantly impacted by substance use. We will measure sleep quality using the Pittsburgh Sleep Quality Index (PSQI)-Brief (Sancho-Domingo et al., 2020), a 6-item questionnaire. Higher scores indicate more difficulty with sleep. This will be obtained a few days before the SKY Recovery program, 1 week after, and 3 weeks after.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start18 Nov 2024
- Primary completion2 Oct 2025
- Study completion2 Oct 2025
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 California, Los AngelesThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a delayed-start (or "wait-list") controlled study. Control participants on the wait-list will receive treatment as usual during data collection. They will receive the intervention after their participation in data collection has been completed.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dara Ghahremani, PhD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510256
- Sponsor's protocol ID
- IRB-24-1068
- Status last verified
- Mar 2026
- First submitted
- 29 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of SKY Breathwork and Meditation Program on Emotional Well-being and Craving in Individuals Recovering From Substance Use Disorder
- ClinicalTrials.gov ID
- NCT07510256
- Acronym / sponsor ID
- IRB-24-1068
- Conditions
- Addiction, Addiction Disorders
- Keywords
- breathwork, mind-body practices, controlled breathing, Sudarshan Kriya Yoga, addiction recovery, biopsychosocial interventions, substance use disorder, residential treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 2 Oct 2025 (actual)
- Study completion
- 2 Oct 2025 (actual)
- First posted
- 3 Apr 2026 (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.
Emotional wellness can play a vital role in supporting recovery from substance use disorder (SUD). Developing skills to regulate emotions and manage stress during early stages of recovery can help manage triggers and prevent relapse. Controlled breathing (i.e., intentional manipulation of rate and/or depth of breathing over time - often referred to as "breathwork") can enhance emotion regulation, but their effects have been minimally studied in individuals recovering from SUD.
This randomized controlled pilot study will examine the impact of breathwork and meditation training program ("SKY Recovery") designed for people in substance use recovery. It will take place at a residential substance use recovery treatment center in upstate New York with patients in recovery who have elected to participate in the SKY Recovery program delivered at the treatment center. The study will compare two groups (SKY Recovery vs. Control) to assess the intervention's impact on emotional well-being and craving. Participants randomized to the SKY group will complete a 5-day intensive workshop followed by weekly follow-up sessions. The Control group will receive the same intervention after a delay. Validated measures of emotion regulation, craving, and sleep quality will be collected at baseline, one week after the program, and again 3 weeks after the program to determine efficacy and feasibility for a larger trial.
Detailed description
Emotional wellness can play a vital role in supporting recovery from substance use disorder. Developing skills to regulate emotions and manage stress during early stages of recovery can help manage triggers and prevent relapse. Controlled breathing (i.e., intentional manipulation of rate and/or depth of breathing over time - or "breathwork") can enhance emotional wellbeing (e.g., improve emotion regulation), but very little research has explored the impact of breathwork as a healthy coping mechanism for managing emotions and triggers in the context of recovery from substance use disorder.
The goal of this study is to obtain initial data on efficacy of a biopsychosocial intervention that involves breathwork as an adjunct to standard care in a residential treatment setting. Biopsychosocial interventions (e.g., "SKY Recovery") that focus on breathwork techniques, such as Sudarshan Kriya Yoga (SKY), reduce stress, anxiety and depressive symptoms in healthy individuals as well as those with depression, anxiety, and Post-traumatic Stress Disorder. They also reduce craving and withdrawal symptoms in people with Tobacco Use Disorder. Breathwork interventions improve quality of life, particularly in the psychological dimension, for people with opioid use disorder, reducing craving, depression, and increasing social and physical functioning. Craving and withdrawal symptoms promote the maintenance of addiction and predict return to substance misuse, and they are linked to the stress response in people who have substance use disorders. Results of prior studies thereby offer the promise of breathwork as adjunctive therapy for substance use disorder (SUD). Yet, breathwork has only minimally been examined in people with SUDs.
The aims of this pilot study are to evaluate the effectiveness of the SKY Recovery program in individuals with SUDs on emotional wellbeing and craving. Emotion regulation, impulsivity, and distress tolerance will be measured as indicators of emotional wellbeing using self-report questionnaires. 100 adult participants (aiming for 50 male and 50 female, ≥18 years old) who are scheduled to participate in the SKY Recovery program in a residential community treatment center will be enrolled. They will be randomized to two groups: SKY and Control ("delayed start"). Participants in the SKY group will receive the SKY Recovery Program (5 days, 3 h/day) followed by guided weekly in-person group practice sessions (1 h) for 3 weeks. SKY is typically taught in groups; thus, patients will be trained in cohorts of 4-10 people. The delayed-start Control group will receive the SKY Recovery program after all measurements have been obtained from the SKY group. Measurements will be taken before and after the intensive 5-day SKY training, one week after, and again 3 weeks after . Emotional wellbeing (e.g., emotion regulation) will be measured using standardized self-report questionnaires. Craving for their primary substance of choice will be measured using a brief self-report questionnaire. As sleep is related to emotional wellness and is often disrupted in individuals with SUDs, we will also obtain self-report ratings of sleep quality. We will address the following specific aims:
Aim 1. Evaluate the effects of SKY Recovery program on emotional wellbeing in patients receiving treatment for substance use disorder in a residential community setting. Hypothesis 1: Emotion regulation difficulties, impulsivity, and distress intolerance will be reduced and sleep quality will increase relative to baseline - more in the SKY group than in the Control group.
Aim 2. Evaluate the effects of SKY Recovery program on craving in patients receiving treatment for substance use disorder in a residential community setting. Hypothesis 2: Craving will be reduced relative to baseline - more in the SKY group than in the Control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a delayed-start (or "wait-list") controlled study. Control participants on the wait-list will receive treatment as usual during data collection. They will receive the intervention after their participation in data collection has been completed.
| Arm | Type | Receives |
|---|---|---|
| SKY Recovery Intervention | Experimental | Behavioral: SKY Breathing ProgramThe SKY Recovery program centers around a breathing meditation technique, called Sudarshan Kriya Yoga, which consists of multiple, staged components designed to progressively deepen relaxation and bring mental clarity. Participants also learn a mantra-based meditation technique that complements the breathwork. The program also includes education on emotion regulation practices (e.g., cognitive reframing). |
| Delayed-start Control | No intervention | –The delayed-start control group will receive the SKY Recovery program after all measurements have been obtained from the SKY group. Measurements will be taken before and after the intensive 5-day SKY Recovery program, one week later, and at the end (4 weeks after initiation) of the weekly guided practice period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Recovery center patients at Horizon Health Services who are participating in the SKY Recovery program are eligible.
Key exclusion criteria (1 listed)
- Recovery center patients who are not participating in the SKY Recovery program are not eligible for participation.
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 |
|---|---|---|
| SKY Breathing ProgramThe main breathing technique taught in SKY Recovery program consists of multiple, staged components for progressively deeper relaxation and mental clarity. The first component involves a slow breathing technique (ujjayi or "ocean breath") that increases airway resistance during inspiration/expiration and controls airflow to prolong each breathing cycle to an exact count. The subjective experience is physical and mental calmness with alertness. In the second component ("bellows breath"), air is rapidly inhaled and forcefully exhaled at a rate of 30 breaths/minute, leading to excitation followed by calmness. The last component, Sudarshan Kriya ("proper vision by purifying action"), involves cyclical slow/medium/fast breathing. Together, these techniques can take 20 min and is followed by a 5 min rest period (total: 25 min). The program also includes training in mantra-based meditation (Sahaj Samadhi) - invoking a word ("mantra") to redirect the mind towards a meditative state. | Behavioural | SKY Recovery Intervention |
Primary outcome
Emotion regulation
Time frame: 6 weeks
Emotional well-being is a critical factor in stabilized recovery from substance use disorders. Emotion regulation will be measured as an indicator of emotional well-being (primary endpoint) using a standardized self-report questionnaire. The Difficulties in Emotion Regulation Scale is a widely used self-report questionnaire designed to assess problems with emotion regulation, especially how people understand, accept, and manage their emotional responses. We will use the brief version (18-items, Victor \& Klonsky, 2016). This will be obtained a few days before the SKY Recovery program, 1 week after, and 3 weeks after.
Craving
Time frame: 6 weeks
Craving is one of the indicators of recovery from substance use disorder and is closely tied to emotional well-being. Craving for the participant's primary substance of choice will be assessed via self-report using a brief craving scale. The Craving Scale (McHugh et al., 2021) consists of three questions assessing desire to use the substance of choice (1) within the last 24 hours, (2) when imagining being in an environment where the substance was previously used, and (3) when something in the environment reminds them of using the substance. This will be obtained a few days before the SKY Recovery program, 1 week after, and 3 weeks after.
3 secondary outcomes
Impulsivity
Time frame: 6 weeks
Distress intolerance
Time frame: 6 weeks
Sleep Quality
Time frame: 6 weeks
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 3 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SKY Breathing Program in people with Addiction and Addiction Disorders, run by University of California, Los Angeles 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 1 inclusion and 1 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 3 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?
Emotion regulation (time frame: 6 weeks). 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 3 Apr 2026.