Opioid-use DisorderNCT05066321
Mindfulness Oriented Recovery Enhancement in Hospitalized People With Opioid Use Disorder
A study testing Mindfulness Oriented Recovery Enhancement Sessions in people with Opioid-use Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
In this pilot single-armed open-label intervention study of up to 20 individuals with moderate to severe Opioid Use Disorder (OUD)organized into two consecutive groups of up to 10 individuals each, the investigators will measure addiction outcomes and the acceptability and feasibility of adding Mindfulness Oriented… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Mindfulness Oriented Recovery Enhancement Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2022to 1 Sep 2023
- 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
- Participants must be 18 years old and older
- English-speaking
- Hospitalized at Massachusetts General Hospital, being evaluated by the Addiction Consult Team
- Meet DSM-5 criteria for moderate or severe OUD as documented by Addiction Consult Team
Who cannot join
- Individuals currently admitted to an Intensive Care Unit
- Individuals who are in legal custody or will not be discharged from a controlled environment during the study period
- Inability to provide informed consent as assessed by the medical team
- Active COVID-19 infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Division of General Internal Medicine
Boston, Massachusetts, 02114
About this study
Official title: A Pilot Single Arm Intervention Study of Mindfulness Oriented Recovery Enhancement in Hospitalized People With Opioid Use Disorder
In this pilot single-armed open-label intervention study of up to 20 individuals with moderate to severe Opioid Use Disorder (OUD)organized into two consecutive groups of up to 10 individuals each, the investigators will measure addiction outcomes and the acceptability and feasibility of adding Mindfulness Oriented Recovery Enhancement (MORE), a promising mind-body therapy to gold standard in-hospital addiction consultation among hospitalized individuals with OUD in advance of a planned two-arm pilot randomized controlled trial.
Read the detailed description
The investigators will conduct a pilot single-arm intervention study of up to 20 people with moderate to severe OUD. Participants will be enrolled during a hospitalization and receive brief mindfulness training individually in person in the hospital and 8 subsequent sessions of Mindfulness-Oriented Recovery Enhancement (MORE) delivered in small groups of up to 10 people. The intervention will consist of an in-person brief mindfulness training prior to discharge from Massachusetts General Hospital and 8 one-hour group MORE trainings sessions delivered live by a trained addiction social worker over a Zoom telehealth platform.
This study will achieve 2 specific aims. Aim 1 is to quantitatively assess addiction severity, pain, and psychological distress over 12 weeks among people with opioid use disorder receiving manualized Mindfulness-Oriented Recovery Enhancement (MORE) mind-body therapy. Hypothesis 1 is that the receipt of MORE will be associated with decreased addiction severity, pain, and psychological distress among enrolled participants at the end of 12 weeks. Aim 2 is to assess the feasibility and acceptability of conducting a pilot RCT of MORE delivered to people with opioid use disorder and serious bacterial infections. Hypothesis 2 is that more than 50% percent of eligible patients will enroll in the study.
A trained clinical research coordinator (CRC) will attend Addiction Consult Team (ACT) rounds 3 days per week to identify eligible inpatients for this study. Study staff will screen electronic health records (EHR) to confirm eligibility and ask a member of ACT clinical team about the person's suitability to participate given that exclusion criterion may not be known given EHR screening and ACT rounds alone. If the ACT clinician agrees that the participant meets all of the inclusion criteria and none of the exclusion criteria, the ACT clinician will provide the patient with an information sheet about the study. The ACT clinician will then inform the study CRC that the patient has received a brief introduction to the study and is ready to be approached in the hospital using COVID-19 compliant procedures to initiate the consent process.
Prior to receiving the brief mindfulness intervention, enrolled participants will receive and complete a series of quantitative baseline questionnaires (e.g., demographic and substance use history, treatment history) administered by the CRC. These visits will take place in the patient's hospital room (or another private room on the patient's floor in the hospital). At this time, the CRC will also conduct a semi-structured, audio-recorded, qualitative interview with participants. Study outcomes will be assessed in-person at baseline and via mobile phone at 3-, 6-, 9- and 12-week follow-up time points. Upon completion of the intervention and the 12-week follow-up surveys, participants will be asked to complete a 45-60 minute individual exit interview. Informed by an embedded contextual mixed-methods approach, the investigators will also conduct qualitative interviews to better understand why, how, and under what circumstances participants may have achieved reductions in addiction severity in response to MORE.
- Conditions
- Opioid-use Disorder
- Being tested
- Mindfulness Oriented Recovery Enhancement Sessions
- Keywords
- Mindfulness, Behavior, Drug Abuse
- Medical subject headings
- Opioid-Related Disorders, Behavior, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Oriented Recovery Enhancement SessionsBehavioural
The MORE intervention will involve 8 weekly sessions (approximately 1 hour each), during which participants will be taught how to use mindfulness skills to regulate addiction severity, pain, and stress.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Oriented Recovery Enhancement (MORE) Arm | Experimental | During hospitalization, participants will receive brief mindfulness training individually in person and complete a series of quantitative baseline questionnaires. Participants will complete 1 MORE session weekly for 8 sessions delivered in small groups of up to 10 people. These sessions will be delivered by a social worker in-person at baseline, and via telehealth after discharge. Follow-up surveys will be conducted at 3-, 6-. 9-, and 12- weeks, and an audio-recorded qualitative exit interview (45-60 minutes) will be completed upon completion of the intervention and the 12-week follow-up survey. Receives: Behavioral: Mindfulness Oriented Recovery Enhancement Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Addiction Severity
The Treatment Effectiveness Assessment, a 4 question validated patient-reported outcome measure, will be used to quantitatively assess recovery from addiction
Measured: 3 months
Enrollment feasibility as measured by the number of individuals who enroll in the study as compared to those who are eligible to enroll
Enrollment percentage as measured by the number of individuals who enroll in the study as compared to those who are eligible to enroll
Measured: 3 months
Secondary outcomes (5)
Distress Tolerance
The Distress Tolerance Scale, a 15 item validated patient-reported outcome measure, will be used to quantitatively assess multiple domains of distress tolerance. The scale ranges from 1 ("strongly agree") to 5 ("strongly disagree"). A higher score indicates a better outcome, with only one item being reverse coded.
Measured: 3 months
Pain Interference
The Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference scale, a 6 question validated patient-reported outcome measure, will be used to quantitatively assess pain interference. The scale ranges from 1 ("not at all") to 5 ("very much"). A lower score indicates a better outcome.
Measured: 3 months
Pain Severity
The Patient-Reported Outcome Measurement Information System (PROMIS) Pain Severity scale, a 3 question validated patient-reported outcome measure, will be used to quantitatively assess pain severity. The scale ranges from 1 ("had no pain") to 5 ("very severe"). A lower score indicates a better outcome.
Measured: 3 months
Completion of 12-week Follow-up Feasibility
Percentage of those enrolled in the study who complete their 12-week follow-up survey. 100% would be the maximum percentage, and a higher percentage indicates a better outcome.
Measured: 3 months
Completion of at least 4 MORE sessions feasibility
Percentage of those enrolled in the study who complete at least half the MORE sessions
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start18 Mar 2022
- Primary completion1 Sep 2022
- Study completion1 Sep 2023
Why it stopped: Study suspended due to lack of subsequent funding to support the work.
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.
- More trials run by Massachusetts General HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Bearnot, M.D., Massachusetts General Hospital
- Investigators
- Benjamin Bearnot, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066321
- Sponsor's protocol ID
- 2021P002738
- Status last verified
- Mar 2024
- First submitted
- 23 Sep 2021
- Last updated
- 12 Mar 2024
- 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Single Arm Intervention Study of Mindfulness Oriented Recovery Enhancement in Hospitalized People With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT05066321
- Acronym / sponsor ID
- 2021P002738
- Conditions
- Opioid-use Disorder
- Keywords
- Mindfulness, Behavior, Drug Abuse
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study suspended due to lack of subsequent funding to support the work.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 4 Oct 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.
In this pilot single-armed open-label intervention study of up to 20 individuals with moderate to severe Opioid Use Disorder (OUD)organized into two consecutive groups of up to 10 individuals each, the investigators will measure addiction outcomes and the acceptability and feasibility of adding Mindfulness Oriented Recovery Enhancement (MORE), a promising mind-body therapy to gold standard in-hospital addiction consultation among hospitalized individuals with OUD in advance of a planned two-arm pilot randomized controlled trial.
Detailed description
The investigators will conduct a pilot single-arm intervention study of up to 20 people with moderate to severe OUD. Participants will be enrolled during a hospitalization and receive brief mindfulness training individually in person in the hospital and 8 subsequent sessions of Mindfulness-Oriented Recovery Enhancement (MORE) delivered in small groups of up to 10 people. The intervention will consist of an in-person brief mindfulness training prior to discharge from Massachusetts General Hospital and 8 one-hour group MORE trainings sessions delivered live by a trained addiction social worker over a Zoom telehealth platform.
This study will achieve 2 specific aims. Aim 1 is to quantitatively assess addiction severity, pain, and psychological distress over 12 weeks among people with opioid use disorder receiving manualized Mindfulness-Oriented Recovery Enhancement (MORE) mind-body therapy. Hypothesis 1 is that the receipt of MORE will be associated with decreased addiction severity, pain, and psychological distress among enrolled participants at the end of 12 weeks. Aim 2 is to assess the feasibility and acceptability of conducting a pilot RCT of MORE delivered to people with opioid use disorder and serious bacterial infections. Hypothesis 2 is that more than 50% percent of eligible patients will enroll in the study.
A trained clinical research coordinator (CRC) will attend Addiction Consult Team (ACT) rounds 3 days per week to identify eligible inpatients for this study. Study staff will screen electronic health records (EHR) to confirm eligibility and ask a member of ACT clinical team about the person's suitability to participate given that exclusion criterion may not be known given EHR screening and ACT rounds alone. If the ACT clinician agrees that the participant meets all of the inclusion criteria and none of the exclusion criteria, the ACT clinician will provide the patient with an information sheet about the study. The ACT clinician will then inform the study CRC that the patient has received a brief introduction to the study and is ready to be approached in the hospital using COVID-19 compliant procedures to initiate the consent process.
Prior to receiving the brief mindfulness intervention, enrolled participants will receive and complete a series of quantitative baseline questionnaires (e.g., demographic and substance use history, treatment history) administered by the CRC. These visits will take place in the patient's hospital room (or another private room on the patient's floor in the hospital). At this time, the CRC will also conduct a semi-structured, audio-recorded, qualitative interview with participants. Study outcomes will be assessed in-person at baseline and via mobile phone at 3-, 6-, 9- and 12-week follow-up time points. Upon completion of the intervention and the 12-week follow-up surveys, participants will be asked to complete a 45-60 minute individual exit interview. Informed by an embedded contextual mixed-methods approach, the investigators will also conduct qualitative interviews to better understand why, how, and under what circumstances participants may have achieved reductions in addiction severity in response to MORE.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Oriented Recovery Enhancement (MORE) Arm | Experimental | Behavioral: Mindfulness Oriented Recovery Enhancement SessionsDuring hospitalization, participants will receive brief mindfulness training individually in person and complete a series of quantitative baseline questionnaires. Participants will complete 1 MORE session weekly for 8 sessions delivered in small groups of up to 10 people. These sessions will be delivered by a social worker in-person at baseline, and via telehealth after discharge. Follow-up surveys will be conducted at 3-, 6-. 9-, and 12- weeks, and an audio-recorded qualitative exit interview (45-60 minutes) will be completed upon completion of the intervention and the 12-week follow-up survey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must be 18 years old and older
- English-speaking
- Hospitalized at Massachusetts General Hospital, being evaluated by the Addiction Consult Team
- Meet DSM-5 criteria for moderate or severe OUD as documented by Addiction Consult Team
Key exclusion criteria (4 listed)
- Individuals currently admitted to an Intensive Care Unit
- Individuals who are in legal custody or will not be discharged from a controlled environment during the study period
- Inability to provide informed consent as assessed by the medical team
- Active COVID-19 infection
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 |
|---|---|---|
| Mindfulness Oriented Recovery Enhancement SessionsThe MORE intervention will involve 8 weekly sessions (approximately 1 hour each), during which participants will be taught how to use mindfulness skills to regulate addiction severity, pain, and stress. | Behavioural | Mindfulness Oriented Recovery Enhancement (MORE) Arm |
Primary outcome
Addiction Severity
Time frame: 3 months
The Treatment Effectiveness Assessment, a 4 question validated patient-reported outcome measure, will be used to quantitatively assess recovery from addiction
Enrollment feasibility as measured by the number of individuals who enroll in the study as compared to those who are eligible to enroll
Time frame: 3 months
Enrollment percentage as measured by the number of individuals who enroll in the study as compared to those who are eligible to enroll
5 secondary outcomes
Distress Tolerance
Time frame: 3 months
Pain Interference
Time frame: 3 months
Pain Severity
Time frame: 3 months
Completion of 12-week Follow-up Feasibility
Time frame: 3 months
Completion of at least 4 MORE sessions feasibility
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Study suspended due to lack of subsequent funding to support the work.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- 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.
Benjamin Bearnot, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Oriented Recovery Enhancement Sessions in people with Opioid-use Disorder, run by Massachusetts General Hospital 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 12 Mar 2024. 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 was stopped early (reason given: Study suspended due to lack of subsequent funding to support the work.). Results are not available in the source record.
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?
Addiction Severity (time frame: 3 months). 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 12 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.