Mindfulness Oriented Recovery Enhancement in Hospitalized People With Opioid Use Disorder

NCT ID: NCT05066321

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-18
• Study Completion Date: 2023-09-01

Brief 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 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.

Conditions

Opioid-use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mindfulness Oriented Recovery Enhancement (MORE) Arm

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.

Group Type: EXPERIMENTAL

Mindfulness Oriented Recovery Enhancement Sessions

Intervention Type: BEHAVIORAL

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.

Interventions

Mindfulness Oriented Recovery Enhancement Sessions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Benjamin Bearnot, M.D.

Instructor of Medicine, Department of Medicine, Harvard Medical School; Assistant in Medicine, Massachusetts General Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin Bearnot, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Division of General Internal Medicine

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2021P002738

Identifier Type: -

Identifier Source: org_study_id