N/A
Completed N=30
Pilot of Mindfulness Oriented Recovery Enhancement in MethadoneTreatment
Source: ClinicalTrials.gov NCT03894501 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcomePrimary: Study Interest — 32 Participants
Summary
This pilot study aims to evaluate the impact of a novel intervention, Mindfulness Oriented Recovery Enhancement (MORE), on opioid use and chronic pain among individuals receiving methadone maintenance treatment (MMT). The main goal of this pilot study is to test the feasibility of our study methods before conducting a clinical trial to assess MORE with respect to a range of clinical outcomes. This study will involve a 2-arm individually randomized controlled trial design that compares MORE and treatment as usual (TAU).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Study Interest |
32 | — |
| PRIMARY Study Refusal |
2 | — |
| PRIMARY Individuals Screened |
— | — |
| PRIMARY Individuals Consented. |
31 | — |
| PRIMARY Refusal After/During Consent Process. |
1 | — |
| PRIMARY Mean Sessions Completed |
6.4 | — |
| PRIMARY Percentage of Sessions Completed |
76 | — |
| PRIMARY Number Who Drop Out |
— | — |
| PRIMARY Percentage Who Drop Out |
— | — |
| PRIMARY Baselines Completed |
30 | — |
| PRIMARY Percentage Baselines Completed |
100 | — |
| PRIMARY 8-weeks Completed |
30 | — |
| PRIMARY Percentage 8-Weeks Completed |
100 | — |
| PRIMARY 16-Weeks Completed |
29 | — |
| PRIMARY Percentage of 16-Weeks Completed |
96.7 | — |
| SECONDARY Days of Illicit Drug Use |
6.37; 15.56 | .048 sig |
| SECONDARY Days of Illicit Opioid Use |
2.47; 5.49 | .037 sig |
| SECONDARY Opioid Craving |
15.52; 21.35 | .024 sig |
| SECONDARY Pain Level. |
50.76; 26.65 | .005 sig |
| SECONDARY Depression Level. |
34.11; 42.93 | .013 sig |
| SECONDARY Anxiety Level. |
41.05; 50.83 | .035 sig |
Eligibility Criteria
Inclusion Criteria
- Age 18 or older
- English-speaking
- Been in methadone treatment for at least 3 months
- Experience a non-malignant pain (with an intensity level of 8 or higher on the Gracely Box Scale) for a duration of 2 months or longer.
Exclusion Criteria
- Exhibit cognitive impairment (score <24 on the Mini Mental Status Exam)
- Exhibit psychosis (positive SCID Psychotic Screen),
- Are at suicidal risk (positive score on ASQ Suicide Risk Screening Tool)
- Unable to attend group sessions due to distance, work, commitments or other logistical problems,
- Are currently pregnant or breastfeeding
- Are planning to be pregnant or breastfeeding the next 16 weeks.
Data sourced from ClinicalTrials.gov (NCT03894501). 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. Informational only — not medical advice.