Opioid-use DisorderBEINGNCT04879238
Tailoring a Mindful Intervention to Enhance Opioid Treatment
A study testing BEING in people with Opioid-use Disorder, run by University of Connecticut at 1 site in United States.
Trial summary
The main aim of this study is to better understand whether yoga can be blended with mindfulness as an additional intervention for people receiving medication assisted treatment at a Hartford-based community agency. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- BEING
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2021to 31 Aug 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Receiving Medication Assisted Treatment 18 years or older Released from incarceration within the past year Currently receiving services from the partnering community agency English speaking
Who cannot join
- Under 18 years old Non-English Speaking Current incarcerated Not receiving Medication Assisted Treatment Not receiving services from the partnering community agency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tailoring a Mindful Intervention to Enhance Opioid Treatment Outcomes in a Community Program
The main aim of this study is to better understand whether yoga can be blended with mindfulness as an additional intervention for people receiving medication assisted treatment at a Hartford-based community agency. If this program is acceptable to participants, then additional studies can allow us to determine its impact on stress and cravings. This intervention, developed by the researchers, is called BEING.
Read the detailed description
This study is a micro-trial of our mindful yoga intervention, BEING, tailored to the MAT clients. This study adapts an existing manualized program of yoga and mindfulness intervention (BEING) for MAT participants. Particularly important is addressing potential challenges and concerns regarding acceptability and feasibility of implementation in vulnerable males with substance dependence. We are enlisting the support of a mindful yoga expert with experience in related populations (i.e., previously incarcerated male veterans with mental health issues) in the adaptation process. This study is designed primarily to test the feasibility of the implementation of the intervention. We cannot draw statistically valid conclusions about the impact the intervention on outcomes, given the overall study design. We plan to collect participant feedback on whether or not the intervention is acceptable. We also want to evaluate the availability, accessibility, acceptability and feasibility of collecting certain measures that would be collected in a subsequent adequately powered treatment study.
- Conditions
- Opioid-use Disorder
- Being tested
- BEING
- Keywords
- Medication Assisted Treatment
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEINGBehavioural
Also called Yoga-Mindfulness
60 minute yoga session that blends mindfulness techniques
| Study group | Role | What they receive |
|---|---|---|
| Yoga-Mindfulness Intervention | Experimental | Completing single session of yoga blended with mindfulness. Receives: Behavioral: BEING |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Responses to questions about how acceptable participants found the intervention. The questions are indicated below: All questions can be responded to with one of the following answers:
Completely disagree; disagree; neither agree nor disagree; agree; completely agree.
I approve of the yoga and mindfulness training.
I find the yoga and mindfulness training interesting.
I like the yoga and mindfulness training.
I welcome the yoga and mindfulness training.
The training seems appropriate.
The training applies to me.
The training seems right for me.
The training seems like a good match for me.
The training seems easy to carry out.
The training seems possible.
The training seems doable.
The training seems easy to use.
Measured: 3 months following pre-test
Adherence (self report)
Adherence to MAT per client self report-Response to question on whether they are still on MAT.
Measured: 3 months following pre-test
Adherence (record review)
Review of client chart to see if the client is still on MAT and taking as prescribed.
Measured: 3 months following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start27 Apr 2021
- Primary completion30 Jul 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Yoga and Mindfulness intervention
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Fendrich, University of Connecticut
- Investigators
- Michael Fendrich, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879238
- Sponsor's protocol ID
- H20-0111
- Acronym
- BEING
- Status last verified
- Nov 2022
- First submitted
- 5 May 2021
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Requests for participant data will be considered on an individual basis.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailoring a Mindful Intervention to Enhance Opioid Treatment Outcomes in a Community Program
- ClinicalTrials.gov ID
- NCT04879238
- Acronym / sponsor ID
- BEING / H20-0111
- Conditions
- Opioid-use Disorder
- Keywords
- Medication Assisted Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 10 May 2021 (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 main aim of this study is to better understand whether yoga can be blended with mindfulness as an additional intervention for people receiving medication assisted treatment at a Hartford-based community agency. If this program is acceptable to participants, then additional studies can allow us to determine its impact on stress and cravings. This intervention, developed by the researchers, is called BEING.
Detailed description
This study is a micro-trial of our mindful yoga intervention, BEING, tailored to the MAT clients. This study adapts an existing manualized program of yoga and mindfulness intervention (BEING) for MAT participants. Particularly important is addressing potential challenges and concerns regarding acceptability and feasibility of implementation in vulnerable males with substance dependence. We are enlisting the support of a mindful yoga expert with experience in related populations (i.e., previously incarcerated male veterans with mental health issues) in the adaptation process. This study is designed primarily to test the feasibility of the implementation of the intervention. We cannot draw statistically valid conclusions about the impact the intervention on outcomes, given the overall study design. We plan to collect participant feedback on whether or not the intervention is acceptable. We also want to evaluate the availability, accessibility, acceptability and feasibility of collecting certain measures that would be collected in a subsequent adequately powered treatment study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Yoga and Mindfulness intervention
| Arm | Type | Receives |
|---|---|---|
| Yoga-Mindfulness Intervention | Experimental | Behavioral: BEINGCompleting single session of yoga blended with mindfulness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Receiving Medication Assisted Treatment 18 years or older Released from incarceration within the past year Currently receiving services from the partnering community agency English speaking
Key exclusion criteria (1 listed)
- Under 18 years old Non-English Speaking Current incarcerated Not receiving Medication Assisted Treatment Not receiving services from the partnering community agency
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 |
|---|---|---|
| BEINGAlso: Yoga-Mindfulness60 minute yoga session that blends mindfulness techniques | Behavioural | Yoga-Mindfulness Intervention |
Primary outcome
Acceptability
Time frame: 3 months following pre-test
Responses to questions about how acceptable participants found the intervention. The questions are indicated below: All questions can be responded to with one of the following answers: Completely disagree; disagree; neither agree nor disagree; agree; completely agree. I approve of the yoga and mindfulness training. I find the yoga and mindfulness training interesting. I like the yoga and mindfulness training. I welcome the yoga and mindfulness training. The training seems appropriate. The training applies to me. The training seems right for me. The training seems like a good match for me. The training seems easy to carry out. The training seems possible. The training seems doable. The training seems easy to use.
Adherence (self report)
Time frame: 3 months following pre-test
Adherence to MAT per client self report-Response to question on whether they are still on MAT.
Adherence (record review)
Time frame: 3 months following intervention
Review of client chart to see if the client is still on MAT and taking as prescribed.
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 9 Nov 2022.
- Individual participant dataSharing planned: No. Requests for participant data will be considered on an individual basis.
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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.
Michael Fendrich, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BEING in people with Opioid-use Disorder, run by University of Connecticut 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 9 Nov 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?
Acceptability (time frame: 3 months following pre-test). The study lists 3 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 9 Nov 2022.