Mindfulness Therapy + Methadone for Opioid Use Disorder

(IMPOWR-MORE Trial)

Recruiting at 1 trial location

Overseen By Eric Garland, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Rutgers, The State University of New Jersey

Must be taking: Methadone

Disqualifiers: Severe cognitive impairment, psychosis, suicidal risk, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

450 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you continue methadone treatment.

How is the Mindfulness Therapy + Methadone treatment different from other treatments for opioid use disorder?

This treatment is unique because it combines methadone, a medication that helps reduce withdrawal symptoms, with Mindfulness-Oriented Recovery Enhancement (MORE), a therapy that integrates mindfulness, cognitive behavioral therapy, and positive psychology to address both opioid use and chronic pain, which are often linked. ^{1 2 3 4 5}

Research Team

Eric Garland, Ph

Principal Investigator

Rutgers Robert Wood Johnson Medical School

Eligibility Criteria

This trial is for English-speaking adults over 18 who are on methadone treatment and have been experiencing pain for at least three months. It's not suitable for those unable to attend sessions, with severe cognitive issues or psychosis, at risk of suicide, or with previous formal mindfulness training.

Inclusion Criteria

I am 18 years old or older.

I am currently taking methadone.

I have had pain that has lasted for more than 3 months.

Exclusion Criteria

I have completed a formal mindfulness training program.

I can attend and fully participate in all sessions and assessments.

You have significant problems with memory or thinking, or you experience hallucinations or delusions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Mindfulness-Oriented Recovery Enhancement, Scripted Mindfulness Practice, or Treatment-as-Usual alongside methadone treatment

8 weeks

8 group sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including drug use, craving, and chronic pain

52 weeks

Treatment Details

Interventions

• Mindfulness Oriented Recovery Enhancement (MORE)
• Scripted Mindfulness Practice (SMP)

Trial Overview The study tests Mindfulness-Oriented Recovery Enhancement (MORE) as an add-on to standard methadone treatment for opioid use disorder. Participants will try either a high-intensity MORE strategy, a minimal intensity scripted practice (SMP), or continue regular treatment without additional interventions.

Participant Groups

Group I: MORE Experimental Treatment 1 Intervention

Eight group sessions of Mindfulness-Oriented Recovery Enhancement plus methadone treatment as usual (TAU)

Group II: Scripted Mindfulness Practice (SMP) Active Control 1 Intervention

Eight group sessions of scripted mindfulness practice plus TAU.

Group III: Treatment-as-Usual Active Control 1 Intervention

Methadone treatment as usual.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Findings from Research

In a study of 30 individuals undergoing methadone maintenance treatment (MMT), those who participated in Mindfulness-Oriented Recovery Enhancement (MORE) experienced significantly fewer days of illicit drug use and lower cravings compared to those receiving standard treatment alone over a 16-week follow-up period.

Participants in the MORE group also reported reduced pain, lower levels of depression and anxiety, and improved well-being and social functioning, suggesting that MORE may effectively address both chronic pain and opioid use disorder in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized clinical trial of mindfulness-oriented recovery enhancement as an adjunct to methadone treatment for people with opioid use disorder and chronic pain: Impact on illicit drug use, health, and well-being. Cooperman, NA., Hanley, AW., Kline, A., et al.[2022]

The 8-week Mindfulness-Oriented Recovery Enhancement (MORE) intervention significantly improved emotional regulation in women undergoing treatment for opioid use disorder, as evidenced by decreased difficulty in managing emotions after the program.

Functional MRI results showed increased connectivity in brain regions associated with affect regulation after the MORE intervention, suggesting that this mindfulness approach may enhance brain function related to emotional control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-oriented recovery enhancement in opioid use disorder: Extended emotional regulation and neural effects and immediate effects of guided meditation in a pilot sample. Ray, S., Bhanji, J., Kennelly, N., et al.[2023]

The Mindfulness-Oriented Recovery Enhancement Fidelity Measure (MORE-FM) was developed and validated to assess therapist competence and adherence to the MORE treatment manual, showing high internal consistency and adequate reliability across 40 treatment sessions involving 295 participants.

Higher fidelity in delivering the MORE treatment was linked to significant reductions in opioid misuse, suggesting that the MORE-FM is an effective tool for ensuring treatment integrity and predicting positive clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mindfulness-Oriented Recovery Enhancement Fidelity Measure (MORE-FM): Development and Validation of a New Tool to Assess Therapist Adherence and Competence. Hanley, AW., Garland, EL.[2022]

A pilot study involving 15 adults in a 6-week Mindfulness-Based Relapse Prevention (MBRP) course showed that this approach is feasible and acceptable for individuals undergoing Methadone Maintenance Therapy (MMT) for opiate addiction.

Participants experienced significant reductions in depression, craving, and trauma symptoms after the course, suggesting that MBRP may enhance the effectiveness of MMT in treating opiate addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Relapse Prevention for Methadone Maintenance: A Feasibility Trial. Bowen, S., Somohano, VC., Rutkie, RE., et al.[2017]

The Mindful Recovery OUD Care Continuum (M-ROCC) program, a 24-week mindfulness-based intervention, significantly reduced comorbid pain and anxiety in patients undergoing buprenorphine treatment, as evidenced by improved scores on various psychological scales and decreased substance use.

Participants showed a notable decrease in positive urine toxicology results for cocaine and benzodiazepines, indicating that M-ROCC may help enhance retention in treatment and prevent substance misuse during opioid therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a trauma-informed mindful recovery program on comorbid pain, anxiety, and substance use during primary care buprenorphine treatment: A proof-of-concept study. Schuman-Olivier, Z., Fatkin, T., Creedon, TB., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

A pilot randomized clinical trial of mindfulness-oriented recovery enhancement as an adjunct to methadone treatment for people with opioid use disorder and chronic pain: Impact on illicit drug use, health, and well-being. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-oriented recovery enhancement in opioid use disorder: Extended emotional regulation and neural effects and immediate effects of guided meditation in a pilot sample. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

The Mindfulness-Oriented Recovery Enhancement Fidelity Measure (MORE-FM): Development and Validation of a New Tool to Assess Therapist Adherence and Competence. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Relapse Prevention for Methadone Maintenance: A Feasibility Trial. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Effects of a trauma-informed mindful recovery program on comorbid pain, anxiety, and substance use during primary care buprenorphine treatment: A proof-of-concept study. [2023]