AzTrials
AzTrials

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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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
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

Other trials in United States

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.

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 groups in NCT05066321
Study groupRoleWhat they receive
Mindfulness Oriented Recovery Enhancement (MORE) ArmExperimentalDuring 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted4 Oct 2021
  2. Study start18 Mar 2022
  3. Primary completion1 Sep 2022
  4. Study completion1 Sep 2023

Why it stopped: Study suspended due to lack of subsequent funding to support the work.

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in