The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment (IMPOWR-MORE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06032559
Recruitment Status : Recruiting
First Posted : September 13, 2023
Last Update Posted : October 10, 2023
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
University of Utah
Information provided by (Responsible Party):
Nina A. Cooperman, Psy. D., Rutgers, The State University of New Jersey

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

This hybrid implementation-effectiveness trial will evaluate Mindfulness-Oriented Recovery Enhancement (MORE) for patients with opioid use disorder receiving methadone treatment (MT). The investigators will also assess barriers and facilitators to integrating MORE into methadone treatment, and evaluate the impact of a sustainable train-the-trainer model on provider burden, intervention fidelity, intervention engagement, and outcomes. Participants will be assigned to a higher intensity MORE implementation strategy, a minimal intensity implementation strategy consisting of a simple, scripted mindfulness practice (SMP) extracted from the MORE treatment manual with minimal training and feedback and no supervision, or methadone treatment as usual (TAU). We aim to:

  • Examine barriers and facilitators to the implementation of MORE and SMP in MT and evaluate strategies for optimizing training, fidelity, and engagement.
  • Evaluate the effectiveness and treatment fidelity of a higher intensity MORE implementation strategy versus a lower intensity, scripted mindfulness practice (SMP) implementation strategy as an adjunct to methadone TAU or methadone TAU, only. Outcomes include opioid and other drug use, craving, MT discontinuation, depression, anxiety, and physical pain (secondary outcomes) than patients randomized to TAU.

Condition or disease Intervention/treatment Phase
Opioid Use Pain Behavioral: MORE Behavioral: SMP Other: TAU Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment for Opioid Use Disorder and Chronic Pain
Actual Study Start Date : September 4, 2023
Estimated Primary Completion Date : March 30, 2026
Estimated Study Completion Date : March 30, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
Drug Information available for: Methadone

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: MORE
Eight group sessions of Mindfulness-Oriented Recovery Enhancement plus methadone treatment as usual (TAU)
 Behavioral: MORE
MORE plus TAU
Active Comparator: Scripted Mindfulness Practice (SMP)
Eight group sessions of scripted mindfulness practice plus TAU.
 Behavioral: SMP
SMP plus TAU
Active Comparator: Treatment-as-Usual
Methadone treatment as usual.
 Other: TAU
TAU only


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Days of drug use [ Time Frame: Baseline through 52 weeks ]
    mber of days of drug use as measured by self-reported days of use and biochemically verified use via drug screen.


Secondary Outcome Measures :
  1. Chronic Pain [ Time Frame: Baseline through 52 weeks ]
    Chronic pain measured by the Brief Pain Inventory Short Form (range 0-10, with higher scores indicating worse pain).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English-speaking
  • age ≥18
  • currently on methadone
  • persistent or recurring pain that has lasted for a duration of 3 months of longer.

Exclusion Criteria:

  • severe cognitive impairment (score >23 on Mini Mental Status Exam) or psychosis (positive SCID Psychotic Screen)
  • suicidal risk (score ≥7 on Suicidal Behaviors Questionnaire)
  • inability to attend or fully participate in intervention sessions or assessments
  • previous formal mindfulness training (e.g., MBSR, MBRP) or MORE (from the R21 or R33 studies).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06032559


Contacts
Layout table for location contacts
Contact: Nina Cooperman, PsyD 732-235-8569 cooperna@rwjms.rutgers.edu
Contact: Eric Garland, PhD 801-581-3826 eric.garland@socwk.utah.edu

Locations
Layout table for location information
United States, New Jersey
Rutgers Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Nina Cooperman    732-235-8569    cooperna@rwjms.rutgers.edu   
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 04108
Contact: Ericc Garland, PhD    801-581-3826    Eric.Garland@socwk.utah.edu   
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Institute on Drug Abuse (NIDA)
University of Utah
Investigators
Layout table for investigator information
Principal Investigator: Eric Garland, Ph Rutgers Robert Wood Johnson Medical School
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Nina A. Cooperman, Psy. D., Associate Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT06032559    
Other Study ID Numbers: Pro2022001626
R01DA056537 ( U.S. NIH Grant/Contract )
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: October 10, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All participant data collected during the trial will be shared after de-identification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Beginning 3 months and ending five years after study publication.
Access Criteria: Researchers who provide a methodologically sound proposal.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No