Mindfulness Oriented Recovery Enhancement in Hospitalized People With Opioid Use Disorder

NCT05066321 | Terminated

• 1 other identifier: 2021P002738
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-use Disorder

Keywords

Mindfulness; Behavior; Drug Abuse

Outcome Measures

Primary Outcomes (2)

• Addiction Severity

  The Treatment Effectiveness Assessment, a 4 question validated patient-reported outcome measure, will be used to quantitatively assess recovery from addiction

  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

  3 months

Secondary Outcomes (5)

• Distress Tolerance

  3 months

• Pain Interference

  3 months

• Pain Severity

  3 months

• Completion of 12-week Follow-up Feasibility

  3 months

• Completion of at least 4 MORE sessions feasibility

  3 months

Study Arms (1)

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.

Behavioral: Mindfulness Oriented Recovery Enhancement Sessions

Interventions

Mindfulness Oriented Recovery Enhancement Sessions 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.

Mindfulness Oriented Recovery Enhancement (MORE) Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Division of General Internal Medicine

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Behavior; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Benjamin Bearnot, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Medicine, Department of Medicine, Harvard Medical School; Assistant in Medicine, Massachusetts General Hospital

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 4, 2021
• Study Start: March 18, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2023
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)