Clinical trial NCT05066321: Mindfulness Oriented Recovery Enhancement in Hospitalized People With Opioid Use Disorder
Official title: A Pilot Single Arm Intervention Study of Mindfulness Oriented Recovery Enhancement in Hospitalized People With Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Opioid-use Disorder
Keywords: Mindfulness
Behavior
Drug Abuse
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Addiction Severity
timeFrame: 3 months
measure: Enrollment feasibility as measured by the number of individuals who enroll in the study as compared to those who are eligible to enroll
timeFrame: 3 months
Secondary outcomes:
measure: Distress Tolerance
timeFrame: 3 months
measure: Pain Interference
timeFrame: 3 months
measure: Pain Severity
timeFrame: 3 months
measure: Completion of 12-week Follow-up Feasibility
timeFrame: 3 months
measure: Completion of at least 4 MORE sessions feasibility
timeFrame: 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Division of General Internal Medicine
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Benjamin Bearnot, MD
role: PRINCIPAL_INVESTIGATOR
References: