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Clinical Trial Summary

In this pilot single-armed open-label intervention study of up to 10 individuals with Opioid Use Disorder (OUD) and serious bacterial infections (SBI) organized into two consecutive groups of up to 5 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-SBI in advance of a planned two-arm pilot randomized controlled trial.


Clinical Trial Description

The investigators will conduct a pilot single-arm intervention study of up to 10 people with OUD and SBI. 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 5 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 and serious bacterial infections 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 invesitgators 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


Related Conditions & MeSH terms


NCT number NCT05066321
Study type Interventional
Source Massachusetts General Hospital
Contact Benjamin Bearnot
Phone 617-726-5085
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date December 2021
Completion date December 2022

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