Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment

Pain Clinical Trial

— IMPOWR-MORE  

Official title:

Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment for Opioid Use Disorder and Chronic Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06032559
• Other study ID #: Pro2022001626
• Secondary ID: R01DA056537
• Status: Recruiting
• Phase: Phase 3
• Start date: September 4, 2023
• Est. completion date: March 30, 2027

Study information

• Verified date: October 2023
• Source: Rutgers, The State University of New Jersey
• Contact: Nina Cooperman, PsyD
• Phone: 732-235-8569
• Email: cooperna[@]rwjms.rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: March 30, 2027
• Est. primary completion date: March 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Opioid Use
• Pain

Intervention

Behavioral:
• MORE
MORE plus TAU
• SMP
SMP plus TAU

Other:
• TAU
TAU only

Locations

Country	Name	City	State
United States	Rutgers Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	University of Utah	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Institute on Drug Abuse (NIDA), University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days of drug use	mber of days of drug use as measured by self-reported days of use and biochemically verified use via drug screen.	Baseline through 52 weeks
Secondary	Chronic Pain	Chronic pain measured by the Brief Pain Inventory Short Form (range 0-10, with higher scores indicating worse pain).	Baseline through 52 weeks