N/A
N=154
Mindfulness Oriented Recovery Enhancement for Chronic Pain and Opioid Relapse
Opioid Use · Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT04491968 ↗Enrolled (actual)
154
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Drug Relapse Through 16-weeks. — 39; 44 Participants — p=.02
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindfulness Oriented Recovery Enhancement (Behavioral); Methadone Treatment as Usual (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Drug Relapse Through 16-weeks. |
39; 44 | .02 sig |
| PRIMARY Methadone Treatment Drop Out Through 16-weeks. |
10; 17 | .04 sig |
| SECONDARY Number of Days of Any Drug Use |
13.9; 21.7 | — |
| SECONDARY Number of Days of Opioid Use. |
7.9; 8.5 | — |
| SECONDARY Number of Days of Other Drug Use. |
9.8; 18.3 | — |
| SECONDARY Changes in Craving |
-.49; -.35 | — |
| SECONDARY Changes in Pain. |
-.62; -.25 | — |
| SECONDARY Changes in Depression. |
-3.68; -2.36 | — |
| SECONDARY Changes in Anxiety. |
-2.51; 1.31 | — |
Summary
The objective of this study is to rigorously examine the impact of online MORE, delivered through video conference, on opioid use and chronic pain among individuals receiving methadone maintenance treatment (MMT). This study is a randomized controlled trial to test the efficacy of online MORE on opioid use and chronic pain immediately after treatment and 8-weeks post-treatment as compared to treatment as usual (TAU) among 154 individuals in MMT. Further, mediators (i.e., metacognitive awareness, negative emotion regulation, and natural reward processing) and moderators (i.e., gender, race, income, mental health, trauma, and MMT phase) of treatment response will be explored.
Eligibility Criteria
Inclusion Criteria
- English-speaking
- Age ≥18
- Currently on methadone
- Experiencing non-malignant pain for a duration of 3 months or longer.
Exclusion Criteria
- Severe cognitive impairment or active psychosis
- Suicide risk
- Inability to attend the MORE group, if randomized to that arm.
Data sourced from ClinicalTrials.gov (NCT04491968). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.