Opioid UseSKYNCT03791645
Evaluating The Efficacy Of A Mind-Body Intervention In Overcoming Opioid Addiction
A study testing Sky Intervention in people with Opioid Use and Opioid-use Disorder, run by Ohio State University at 1 site in United States.
Trial summary
This study demonstrates the feasibility, acceptability of SKY program as an adjuvant therapy for American population suffering with OUD through a pilot program in Columbus, Ohio. The aim of this study is to evaluate the SKY program as an adjuvant therapy to treat opioid addiction. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Opioid Use, Opioid-use Disorder, Substance Use Disorders
- What is being tested?
- Sky Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2018to 31 Mar 2022
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The proposed participants are currently residents of Mary Haven
- Are currently undergoing addiction treatment which may include medication assisted treatment as well as counseling.
- The intervention is designed for adults, therefore, only individuals 18 and above will be included in the study.
Who cannot join
- Pregnant women who are beyond their first trimester are excluded from the study as the program requires breathing techniques that are not recommended for pregnant women.
- Also, patients diagnosed with schizophrenia and bipolar disorder will also be excluded from the study, as SKY program is not suitable for people with these conditions.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University College of Social Work
Columbus, Ohio, 43210
About this study
Official title: Evaluating The Efficacy Of A Mind-Body Intervention In Overcoming Opioid Addiction, In Adults Undergoing Opioid Addiction Treatment
This study demonstrates the feasibility, acceptability of SKY program as an adjuvant therapy for American population suffering with OUD through a pilot program in Columbus, Ohio. The aim of this study is to evaluate the SKY program as an adjuvant therapy to treat opioid addiction.
Read the detailed description
This research proposal aims to test the feasibility, acceptability and efficacy of SKY (Sudarshan Kriya Yoga) program, a mind-body intervention, as an adjuvant therapy for people suffering with opioid use disorder (OUD), in Columbus, Ohio. Previous research carried out in India in 2015, has demonstrated that SKY significantly improved the quality of life among people with OUD, however, the suitability, acceptability of SKY program has not been tested among American population. SKY differs from mindfulness and other meditation processes in that, it is a more physiological, rather than cognitive process. It involves controlled breathing techniques that can be easily mastered, and do not require mental effort. The investigator's goals are to a) DEMONSTRATE the feasibility, acceptability and efficacy of SKY program as an adjuvant therapy for American population suffering with OUD. Studies will be carried out in OUD subjects at Mary Haven clinic in Columbus. The efficacy of SKY will be measured using psychometric questionnaires. Feasibility and acceptability will be measured by attendance and attrition.
- Conditions
- Opioid Use, Opioid-use Disorder, Substance Use Disorders
- Being tested
- Sky Intervention
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sky InterventionBehavioural
SKY meditation has three sequential components of breathing interspersed with normal breathing. These include a) sound breath: breathing against airway resistance with slight tightening of the laryngeal muscles, (2-3 cycles/min) followed by b) bellows breath: rapid, forced expiration(20-30 cycles/min) and c) regulated, rhythmical breathing rotating through medium to fast cycles. Each session is focused upon proper breathing techniques, social interaction, and discussion of practical wisdom for everyday life to manage the mind and emotions. SKY will be administered over a 5 day period (~3 hours/day), followed by 4 weekly follow-ups (~90 min session/week) at Signature Health clinic situated in Ashtabula, Ohio.
| Study group | Role | What they receive |
|---|---|---|
| SKY Intervention | Experimental | Participants in the intervention group will get to participate in the SKY program, for 5 days with each day session taking 3 hours/day. SKY program involves a) specific breathing exercises and social interaction with other participants in the program. Following completion of the program, another set of questionnaires will be administered to collect information regarding stress, mood, and opioid use. After completion of the 5 day SKY program, participants will practice SKY every day at home for 30 days. They will also need to attend 4 weekly group sessions during this period and each session is expected to last 1 hour. At the end of the 30 day period, another set of questionnaires will be administered to collect information regarding stress, mood, and opioid use. Receives: Behavioral: Sky Intervention |
| Usual treatment | No intervention | Participants assigned to the control group will not have access to the SKY program but will continue with usual care. They will also complete questions after 5 days and again after 30 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in psychological health following the Sudarshan Kriya Yoga (SKY) therapy
Change in psychological health will be measured using psychometric test administered to subjects at Signature Health clinic in Ashtabula, Ohio. The Pychometric test will involve completion of a Basic 24 Questionnaire: It is a leading behavioral health assessment tool which consists of 24 questions that cover depression and functioning.
Measured: Before SKY intervention, 1 hour after intervention and 1 month after intervention
Change in the number of participants that complete the Sudarshan Kriya Yoga (SKY) therapy
To study the acceptability of the SKY program as an adjuvant therapy for American population suffering with mental disorders + opioid addiction, the attendance and attrition of the subjects at the Signature Health clinic in Ashtabula in the SKY therapy sessions will be recorded by keeping record of those that complete each progressive therapy session.
Measured: Time 1 = initial therapy session, Time 2 = week 1 post therapy session, Time 3 = week 2 post therapy session Time 4 = week 3 post therapy session, Time 5 = week 4 post therapy session Time 6 = 30 minutes daily home practice for 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start27 Oct 2018
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Single group
- Model description
- SKY program includes gentle stretches, SK breathing, and cognitive coping and stressor evaluation strategies. SK breathing, the cornerstone of SKY program contains the following breathing components 1) Three-stage Ujjayi, 2) Bhastrika and 3) Rhythmic Breathing. Three-Stage Ujjayi is an advanced form, with each respiratory cycle lasting approximately twenty seconds. Bhastrika, involves vigorous and faster breathing, at about 20 to 30 respiratory cycles lasting 60 seconds. Three 1-minute rounds of Bhastrika are each followed by 20 seconds of normal breathing. Rhythmic breathing are slow, medium, and fast breathing cycles in succession. Respiratory rates range from about 8-12 respiratory cycles lasting approximately 10 minutes. The participant rotates through these breathing patterns. Upon completion of SKY program, participants will be given a home SK practice which takes approximately 25 minutes daily. Once a week, a 60-90 minutes group follow up SKY session will be held
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keith Warren, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791645
- Sponsor's protocol ID
- 2018H0409
- Acronym
- SKY
- Status last verified
- Oct 2022
- First submitted
- 7 Nov 2018
- Last updated
- 13 Oct 2022
- 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 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating The Efficacy Of A Mind-Body Intervention In Overcoming Opioid Addiction, In Adults Undergoing Opioid Addiction Treatment
- ClinicalTrials.gov ID
- NCT03791645
- Acronym / sponsor ID
- SKY / 2018H0409
- Conditions
- Opioid Use, Opioid-use Disorder, Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 27 Oct 2018 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 2 Jan 2019 (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.
This study demonstrates the feasibility, acceptability of SKY program as an adjuvant therapy for American population suffering with OUD through a pilot program in Columbus, Ohio. The aim of this study is to evaluate the SKY program as an adjuvant therapy to treat opioid addiction.
Detailed description
This research proposal aims to test the feasibility, acceptability and efficacy of SKY (Sudarshan Kriya Yoga) program, a mind-body intervention, as an adjuvant therapy for people suffering with opioid use disorder (OUD), in Columbus, Ohio. Previous research carried out in India in 2015, has demonstrated that SKY significantly improved the quality of life among people with OUD, however, the suitability, acceptability of SKY program has not been tested among American population. SKY differs from mindfulness and other meditation processes in that, it is a more physiological, rather than cognitive process. It involves controlled breathing techniques that can be easily mastered, and do not require mental effort. The investigator's goals are to a) DEMONSTRATE the feasibility, acceptability and efficacy of SKY program as an adjuvant therapy for American population suffering with OUD. Studies will be carried out in OUD subjects at Mary Haven clinic in Columbus. The efficacy of SKY will be measured using psychometric questionnaires. Feasibility and acceptability will be measured by attendance and attrition.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- SKY program includes gentle stretches, SK breathing, and cognitive coping and stressor evaluation strategies. SK breathing, the cornerstone of SKY program contains the following breathing components 1) Three-stage Ujjayi, 2) Bhastrika and 3) Rhythmic Breathing. Three-Stage Ujjayi is an advanced form, with each respiratory cycle lasting approximately twenty seconds. Bhastrika, involves vigorous and faster breathing, at about 20 to 30 respiratory cycles lasting 60 seconds. Three 1-minute rounds of Bhastrika are each followed by 20 seconds of normal breathing. Rhythmic breathing are slow, medium, and fast breathing cycles in succession. Respiratory rates range from about 8-12 respiratory cycles lasting approximately 10 minutes. The participant rotates through these breathing patterns. Upon completion of SKY program, participants will be given a home SK practice which takes approximately 25 minutes daily. Once a week, a 60-90 minutes group follow up SKY session will be held
| Arm | Type | Receives |
|---|---|---|
| SKY Intervention | Experimental | Behavioral: Sky InterventionParticipants in the intervention group will get to participate in the SKY program, for 5 days with each day session taking 3 hours/day. SKY program involves a) specific breathing exercises and social interaction with other participants in the program. Following completion of the program, another set of questionnaires will be administered to collect information regarding stress, mood, and opioid use. After completion of the 5 day SKY program, participants will practice SKY every day at home for 30 days. They will also need to attend 4 weekly group sessions during this period and each session is expected to last 1 hour. At the end of the 30 day period, another set of questionnaires will be administered to collect information regarding stress, mood, and opioid use. |
| Usual treatment | No intervention | –Participants assigned to the control group will not have access to the SKY program but will continue with usual care. They will also complete questions after 5 days and again after 30 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The proposed participants are currently residents of Mary Haven
- Are currently undergoing addiction treatment which may include medication assisted treatment as well as counseling.
- The intervention is designed for adults, therefore, only individuals 18 and above will be included in the study.
Key exclusion criteria (2 listed)
- Pregnant women who are beyond their first trimester are excluded from the study as the program requires breathing techniques that are not recommended for pregnant women.
- Also, patients diagnosed with schizophrenia and bipolar disorder will also be excluded from the study, as SKY program is not suitable for people with these conditions.
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 InterventionSKY meditation has three sequential components of breathing interspersed with normal breathing. These include a) sound breath: breathing against airway resistance with slight tightening of the laryngeal muscles, (2-3 cycles/min) followed by b) bellows breath: rapid, forced expiration(20-30 cycles/min) and c) regulated, rhythmical breathing rotating through medium to fast cycles. Each session is focused upon proper breathing techniques, social interaction, and discussion of practical wisdom for everyday life to manage the mind and emotions. SKY will be administered over a 5 day period (~3 hours/day), followed by 4 weekly follow-ups (~90 min session/week) at Signature Health clinic situated in Ashtabula, Ohio. | Behavioural | SKY Intervention |
Primary outcome
Change in psychological health following the Sudarshan Kriya Yoga (SKY) therapy
Time frame: Before SKY intervention, 1 hour after intervention and 1 month after intervention
Change in psychological health will be measured using psychometric test administered to subjects at Signature Health clinic in Ashtabula, Ohio. The Pychometric test will involve completion of a Basic 24 Questionnaire: It is a leading behavioral health assessment tool which consists of 24 questions that cover depression and functioning.
Change in the number of participants that complete the Sudarshan Kriya Yoga (SKY) therapy
Time frame: Time 1 = initial therapy session, Time 2 = week 1 post therapy session, Time 3 = week 2 post therapy session Time 4 = week 3 post therapy session, Time 5 = week 4 post therapy session Time 6 = 30 minutes daily home practice for 30 days
To study the acceptability of the SKY program as an adjuvant therapy for American population suffering with mental disorders + opioid addiction, the attendance and attrition of the subjects at the Signature Health clinic in Ashtabula in the SKY therapy sessions will be recorded by keeping record of those that complete each progressive therapy session.
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 13 Oct 2022.
- 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.
Keith Warren, PhD principal investigator
Ohio State University
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 Intervention in people with Opioid Use and Opioid-use Disorder, run by Ohio State University 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 3 inclusion and 2 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 13 Oct 2022. 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?
Change in psychological health following the Sudarshan Kriya Yoga (SKY) therapy (time frame: Before SKY intervention, 1 hour after intervention and 1 month after intervention). 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 13 Oct 2022.