NCT05042388

Mindfulness-Based Relapse Prevention to Improve Medication Assisted Treatment Adherence and Drug-use Outcomes for Opioid Use Disorder

Completed NA Results posted Last updated 31 March 2026

What this trial tests

NA trial testing Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA) in Opioid-use Disorder in 105 participants. Completed in 20 August 2024.

Timeline

1 August 2021

Primary endpoint
20 August 2024

20 August 2024

Quick facts

Lead sponsor	West Chester University of Pennsylvania
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	105
Start date	1 August 2021
Primary completion	20 August 2024
Estimated completion	20 August 2024
Sites	1 location across United States

Drugs / interventions tested

• Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA)
• Treatment-As-Usual

Conditions studied

• Opioid-use Disorder — all drugs for Opioid-use Disorder →

Sponsor

West Chester University of Pennsylvania

Who can join

18 and older, any sex, with Opioid-use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Adherence to Medication Assisted Treatment (MAT) Primary · Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).

Whether participant received MAT during post-residential-treatment discharge follow-up phase

Group	Value	95% CI
Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA)	32
Treatment-As-Usual (TAU)	17

Adherence to Medication Assisted Treatment (MAT) Primary · Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).

Whether participant received MAT during post-residential-treatment discharge follow-up phase

Group	Value	95% CI
Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA)	25
Treatment-As-Usual (TAU)	15

Adherence to Medication Assisted Treatment (MAT) Primary · Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).

Whether participant received MAT during post-residential-treatment discharge follow-up phase

Group	Value	95% CI
Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA)	20
Treatment-As-Usual (TAU)	12

Opioid Drug Use Primary · Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).

Participant relapse to opioids - Determined by synthesis of data recorded from participant EHR, participant self-report, and/or correspondence with participant healthcare provider. Any discrepancies between data sources (i.e., participant report no use, provider and/or EHR designated Yes to use) were coded as opioid use.

Group	Value	95% CI
Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA)	1
Treatment-As-Usual (TAU)	7

Opioid Drug Use Primary · Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).

Participant relapse to opioids - Determined by synthesis of data recorded from participant EHR, participant self-report, and/or correspondence with participant healthcare provider. Any discrepancies between data sources (i.e., participant report no use, provider and/or EHR designated Yes to use) were coded as opioid use.

Group	Value	95% CI
Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA)	1
Treatment-As-Usual (TAU)	5

Opioid Drug Use Primary · Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).

Participant relapse to opioids - Determined by synthesis of data recorded from participant EHR, participant self-report, and/or correspondence with participant healthcare provider. Any discrepancies between data sources (i.e., participant report no use, provider and/or EHR designated Yes to use) were coded as opioid use.

Group	Value	95% CI
Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA)	3
Treatment-As-Usual (TAU)	2

Dispositional Mindfulness Secondary · Assessed immediately prior to discharge from residential addiction treatment facility.

Cognitive and Affective Mindfulness Scale-Revised (CAMS-R; Feldman et al., 2007): 10-item self-report measure of central mindfulness aspects (i.e., present-centered attention, awareness, nonjudgmental acceptance) using language that does not reference meditation (higher scores = better, greater mindfulness; Range: 0-40). Total score reported.

Group	Value	95% CI
Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA)	28.26	± 6.41
Treatment-As-Usual (TAU)	27.72	± 6.11

Dispositional Mindfulness Secondary · Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).

Cognitive and Affective Mindfulness Scale-Revised (CAMS-R; Feldman et al., 2007): 10-item self-report measure of central mindfulness aspects (i.e., present-centered attention, awareness, nonjudgmental acceptance) using language that does not reference meditation (higher scores = better, greater mindfulness; Range: 0-40). Total score reported.

Group	Value	95% CI
Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA)	29.77	± 6.01
Treatment-As-Usual (TAU)	28.62	± 7.22

Dispositional Mindfulness Secondary · Assessed 2 month following discharge from residential addiction treatment facility (approximately 60 days post-discharge).

Cognitive and Affective Mindfulness Scale-Revised (CAMS-R; Feldman et al., 2007): 10-item self-report measure of central mindfulness aspects (i.e., present-centered attention, awareness, nonjudgmental acceptance) using language that does not reference meditation (higher scores = better, greater mindfulness; Range: 0-40). Total score reported.

Group	Value	95% CI
Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA)	29.29	± 8.24
Treatment-As-Usual (TAU)	29.05	± 6.85

Dispositional Mindfulness Secondary · Assessed 3 month following discharge from residential addiction treatment facility (approximately 90 days post-discharge).

Cognitive and Affective Mindfulness Scale-Revised (CAMS-R; Feldman et al., 2007): 10-item self-report measure of central mindfulness aspects (i.e., present-centered attention, awareness, nonjudgmental acceptance) using language that does not reference meditation (higher scores = better, greater mindfulness; Range: 0-40). Total score reported.

Group	Value	95% CI
Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA)	32.00	± 6.55
Treatment-As-Usual (TAU)	30.22	± 5.82

Global Mental Health Secondary · Assessed immediately prior to discharge from residential addiction treatment facility.

Patient Reported Outcome Measurement Information System - Global Mental Health (PROMIS-GMH; Hays et al., 2009), 4-item self-report measure of general mental health based on a brief assessment of quality of life, mental health, satisfaction with social activities, and emotional problems (higher scores = better, greater mental health; Range: 4-20). Total score reported.

Group	Value	95% CI
Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA)	12.54	± 3.02
Treatment-As-Usual (TAU)	12.33	± 3.20

Opioid Craving Primary · Assessed immediately prior to discharge from residential addiction treatment facility.

Opioid Craving Scale (OCS; McHugh et al., 2014), 3-item self-report questionnaire assessing opioid craving (higher scores = greater opioid craving; Range: 0-30). This scale uses a visual analogue scale ranging from 0 to 10 to assess opioid craving via response to three questions querying current craving (0 = not at all, 10 = extremely), past week desire for opioids when reminded of opiates (0 = no desire, 10 = extremely strong desire), and imagined likelihood of opioid use if in the environment in which opioids were previously used (0 = not at all, 10 = certainty of use). Total score reported.

Group	Value	95% CI
Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA)	4.80	± 5.11
Treatment-As-Usual (TAU)	6.53	± 6.38

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected from participants from the time of enrollment through the end of the follow-up period, up to 3 months (12 weeks) during the post-treatment assessment period (i.e., 3 consecutive months following discharge from residential treatment). Adverse event data were collected from participants throughout the duration of their study enrollment, approximately 6 months (pre-treatment assessment through final follow-up assessment evaluation).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA)

Serious: 1/53 (2%)

Deaths: 0/53

Treatment-As-Usual (TAU)

Serious: 3/52 (6%)

Deaths: 0/52

Serious adverse events (4 terms)

Reaction	System	Mindfulness-Based Relapse …	Treatment-As-Usual (TAU)
Migraine	General disorders	—	—
Drug Use Relapse/Overdose	General disorders	—	—
Psychiatric Hospitalization	Psychiatric disorders	—	—
Drug Use Relapse	Psychiatric disorders	—	—

Most-reported serious reactions: Migraine, Drug Use Relapse/Overdose, Psychiatric Hospitalization, Drug Use Relapse.

Data from ClinicalTrials.gov NCT05042388 adverse events section.

Sponsor's own description

This proposal aims to determine whether an adjunctive Mindfulness-Based Relapse Prevention (MBRP) treatment program improves Medication Assisted Treatment (MAT) adherence and reduces drug-use among opioid use disorder (OUD) patients. The broad long-term objectives of this project are to investigate how integrative pharmacological and behavioral treatments improve OUD treatment outcomes. This study aims to include 200 patients diagnosed with with opioid use disorder (OUD), that are enrolled in a \~60-day residential addiction treatment program. Participant recruitment will prioritize participants that are prescribed MAT for OUD. Participants will be randomly assigned to a MBRP behavioral treatment condition or a non-MBRP treatment-as-usual (TAU) control condition as part of their treatment within the residential addiction treatment program. All participants will be monitored for three-months following their discharge from the program to test the hypotheses that MBRP participants, relative to TAU participants, will (1) demonstrate greater MAT adherence following discharge, and (2) evidence reduced drug-use following discharge.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.